Trial Outcomes & Findings for ExAblate Transcranial MRgFUS of the Subthalamic Nucleus for Treatment of Parkinson's Disease (NCT NCT02246374)
NCT ID: NCT02246374
Last Updated: 2026-08-13
Results Overview
Safety will evaluate the incidence and severity of adverse events associated with ExAblate subthalamotomy for the treatment of Parkinson's Disease motor features.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
7 participants
Primary outcome timeframe
Baseline to 4 months post treatment
Results posted on
2026-08-13
Participant Flow
Participant milestones
| Measure |
ExAblate Treated Arm
ExAblate Transcranial System subthalamotomy for motor symptoms of Parkinson's Disease.
ExAblate Transcranial System: ExAblate Transcranial System subthalamotomy for symptoms of Parkinson's Disease
|
ExAblate Sham Treated Arm
ExAblate Transcranial System sham subthalamotomy for motor symptoms of Parkinson's Disease. Sham subjects completing the 4 Month visit may be offered the actual ExAblate subthalamotomy.
ExAblate Transcranial System: ExAblate Transcranial System subthalamotomy for symptoms of Parkinson's Disease
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
1
|
|
Overall Study
COMPLETED
|
6
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
ExAblate Transcranial MRgFUS of the Subthalamic Nucleus for Treatment of Parkinson's Disease
Baseline characteristics by cohort
| Measure |
ExAblate Treated Arm
n=6 Participants
ExAblate Transcranial System subthalamotomy for motor symptoms of Parkinson's Disease.
ExAblate Transcranial System: ExAblate Transcranial System subthalamotomy for symptoms of Parkinson's Disease
|
ExAblate Sham Treated Arm
n=1 Participants
ExAblate Transcranial System sham subthalamotomy for motor symptoms of Parkinson's Disease. Sham subjects completing the 4 Month visit may be offered the actual ExAblate subthalamotomy.
ExAblate Transcranial System: ExAblate Transcranial System subthalamotomy for symptoms of Parkinson's Disease
|
Total
n=7 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.2 years
STANDARD_DEVIATION 3.6 • n=1 Participants
|
55.6 years
STANDARD_DEVIATION 0 • n=1 Participants
|
61.7 years
STANDARD_DEVIATION 3.5 • n=1 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=1 Participants
|
1 Participants
n=1 Participants
|
3 Participants
n=1 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=1 Participants
|
0 Participants
n=1 Participants
|
4 Participants
n=1 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
5 Participants
n=1 Participants
|
1 Participants
n=1 Participants
|
6 Participants
n=1 Participants
|
|
Race/Ethnicity, Customized
Race · Hispanic
|
1 Participants
n=1 Participants
|
0 Participants
n=1 Participants
|
1 Participants
n=1 Participants
|
|
Region of Enrollment
United States
|
6 Participants
n=1 Participants
|
1 Participants
n=1 Participants
|
7 Participants
n=1 Participants
|
PRIMARY outcome
Timeframe: Baseline to 4 months post treatmentPopulation: The subject in the Exablate Sham Treated arm crossover after 4 months to actual treatment and included in the group Exablate Treeated arm plus crossovers
Safety will evaluate the incidence and severity of adverse events associated with ExAblate subthalamotomy for the treatment of Parkinson's Disease motor features.
Outcome measures
| Measure |
ExAblate Treated Arm
n=6 Participants
ExAblate Transcranial System subthalamotomy for motor symptoms of Parkinson's Disease.
ExAblate Transcranial System: ExAblate Transcranial System subthalamotomy for symptoms of Parkinson's Disease
|
ExAblate Sham Treated Arm
n=1 Participants
ExAblate Transcranial System sham subthalamotomy for motor symptoms of Parkinson's Disease. Sham subjects completing the 4 Month visit may be offered the actual ExAblate subthalamotomy.
ExAblate Transcranial System: ExAblate Transcranial System subthalamotomy for symptoms of Parkinson's Disease
|
Exablate Treated Arm Plus Crossovers
n=7 Participants
This group includes subjects treated with Exablate at the beginning and subjects who cross over after 4 months from the Sham group to be actually treated with Exablate
|
|---|---|---|---|
|
Incidence and Severity of Adverse Events
Persistent falls
|
0 number of events
|
0 number of events
|
1 number of events
|
|
Incidence and Severity of Adverse Events
Hemichorea
|
0 number of events
|
0 number of events
|
1 number of events
|
|
Incidence and Severity of Adverse Events
Ataxia
|
1 number of events
|
0 number of events
|
1 number of events
|
|
Incidence and Severity of Adverse Events
Dyskinesia
|
1 number of events
|
0 number of events
|
1 number of events
|
|
Incidence and Severity of Adverse Events
Dysarthria
|
2 number of events
|
0 number of events
|
3 number of events
|
|
Incidence and Severity of Adverse Events
Imbalance
|
1 number of events
|
0 number of events
|
1 number of events
|
|
Incidence and Severity of Adverse Events
Musculoskeletal weakness
|
2 number of events
|
0 number of events
|
2 number of events
|
|
Incidence and Severity of Adverse Events
Cognitive disturbance
|
1 number of events
|
0 number of events
|
1 number of events
|
|
Incidence and Severity of Adverse Events
Facial Weakness
|
0 number of events
|
0 number of events
|
1 number of events
|
PRIMARY outcome
Timeframe: Baseline to 4 months post treatmentThis is a feasibility trial with no hypothesis testing. Primary efficacy will be evaluated using basic summary statistics including comparison of between- and within-group differences in the mean change (from baseline to 4 months) of the motor MDS-UPDRS Part III score for the side contralateral to subthalamotomy in the off-medication condition. For the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III (Motor Examination), the scores range from a minimum of 0 (no motor symptoms) to a maximum of 132 (severe motor impairment). The Minimal Clinically Important Difference (MCID) for MDS-UPDRS Part III (Motor Examination) generally ranges from 3.25 to 5 points for improvement.
Outcome measures
| Measure |
ExAblate Treated Arm
n=6 Participants
ExAblate Transcranial System subthalamotomy for motor symptoms of Parkinson's Disease.
ExAblate Transcranial System: ExAblate Transcranial System subthalamotomy for symptoms of Parkinson's Disease
|
ExAblate Sham Treated Arm
n=1 Participants
ExAblate Transcranial System sham subthalamotomy for motor symptoms of Parkinson's Disease. Sham subjects completing the 4 Month visit may be offered the actual ExAblate subthalamotomy.
ExAblate Transcranial System: ExAblate Transcranial System subthalamotomy for symptoms of Parkinson's Disease
|
Exablate Treated Arm Plus Crossovers
n=7 Participants
This group includes subjects treated with Exablate at the beginning and subjects who cross over after 4 months from the Sham group to be actually treated with Exablate
|
|---|---|---|---|
|
Mean Change in MDS-UPDRS Part III Scores
Baseline
|
50 score on the scale MDSUPDR part III
Standard Deviation 12.3
|
38 score on the scale MDSUPDR part III
Standard Deviation 0
|
51.7 score on the scale MDSUPDR part III
Standard Deviation 12.1
|
|
Mean Change in MDS-UPDRS Part III Scores
4 Months
|
36.5 score on the scale MDSUPDR part III
Standard Deviation 12.7
|
36 score on the scale MDSUPDR part III
Standard Deviation 0
|
35.6 score on the scale MDSUPDR part III
Standard Deviation 11.8
|
SECONDARY outcome
Timeframe: Baseline to 12- months post treatmentPopulation: The subject in the Exablate Sham Treated arm crossover after 4 months to actual treatment.
Additional safety will be evaluated by follow up of adverse events through 12 months post treatment.
Outcome measures
| Measure |
ExAblate Treated Arm
n=6 Participants
ExAblate Transcranial System subthalamotomy for motor symptoms of Parkinson's Disease.
ExAblate Transcranial System: ExAblate Transcranial System subthalamotomy for symptoms of Parkinson's Disease
|
ExAblate Sham Treated Arm
ExAblate Transcranial System sham subthalamotomy for motor symptoms of Parkinson's Disease. Sham subjects completing the 4 Month visit may be offered the actual ExAblate subthalamotomy.
ExAblate Transcranial System: ExAblate Transcranial System subthalamotomy for symptoms of Parkinson's Disease
|
Exablate Treated Arm Plus Crossovers
n=7 Participants
This group includes subjects treated with Exablate at the beginning and subjects who cross over after 4 months from the Sham group to be actually treated with Exablate
|
|---|---|---|---|
|
Long Term Adverse Events Profile
|
0 number of events
|
—
|
2 number of events
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to 12-months post treatmentPopulation: The subject in the Exablate Sham Treated arm crossover after 4 months to actual treatment.
Long term impact of ExAblate transcranial pallidotomy will be further evaluated using the MPS-UPDRS Part IV scores. Higher scores mean worse outcome. For the Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part IV, the minimum value is 0 and the maximum value is 24. Part IV evaluates the complications of Parkinson's therapy (such as dyskinesias and motor fluctuations) and consists of 6 specific items, each graded on a severity scale of 0 to 4. Higher scores mean worse outcome. The minimal clinically important difference (MCID) for MDS-UPDRS Part IV (Motor Complications) is a change of 0.9 points for improvement.
Outcome measures
| Measure |
ExAblate Treated Arm
n=6 Participants
ExAblate Transcranial System subthalamotomy for motor symptoms of Parkinson's Disease.
ExAblate Transcranial System: ExAblate Transcranial System subthalamotomy for symptoms of Parkinson's Disease
|
ExAblate Sham Treated Arm
ExAblate Transcranial System sham subthalamotomy for motor symptoms of Parkinson's Disease. Sham subjects completing the 4 Month visit may be offered the actual ExAblate subthalamotomy.
ExAblate Transcranial System: ExAblate Transcranial System subthalamotomy for symptoms of Parkinson's Disease
|
Exablate Treated Arm Plus Crossovers
n=7 Participants
This group includes subjects treated with Exablate at the beginning and subjects who cross over after 4 months from the Sham group to be actually treated with Exablate
|
|---|---|---|---|
|
Mean Change in MDS-UPDRS Part IV Scores
Baseline
|
8 score on MDSUPDRS part IV
Standard Deviation 2.7
|
—
|
8.2 score on MDSUPDRS part IV
Standard Deviation 2.5
|
|
Mean Change in MDS-UPDRS Part IV Scores
12 Month
|
0.25 score on MDSUPDRS part IV
Standard Deviation 0.5
|
—
|
0.25 score on MDSUPDRS part IV
Standard Deviation 0.5
|
Adverse Events
ExAblate Sham Treated Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Crossover
Serious events: 1 serious events
Other events: 1 other events
Deaths: 1 deaths
ExAblate Treated Arm
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ExAblate Sham Treated Arm
n=1 participants at risk
ExAblate Transcranial System sham subthalamotomy for motor symptoms of Parkinson's Disease. Sham subjects completing the 4 Month visit may be offered the actual ExAblate subthalamotomy.
ExAblate Transcranial System: ExAblate Transcranial System subthalamotomy for symptoms of Parkinson's Disease
|
Crossover
n=1 participants at risk
Sham subjects completing the 4 Month visit whom crossover to the actual ExAblate subthalamotomy.
|
ExAblate Treated Arm
n=6 participants at risk
ExAblate Transcranial System subthalamotomy for motor symptoms of Parkinson's Disease.
ExAblate Transcranial System: ExAblate Transcranial System subthalamotomy for symptoms of Parkinson's Disease
|
|---|---|---|---|
|
Nervous system disorders
Hemichorea
|
0.00%
0/1 • Adverse events have been recorded starting from treatment up to 1 year follow up.
Adverse events have been recorded and categorized according to severity, relationship to procedure and relationship to device starting from treatment up to 1 year follow up. .All AEs has been assessed for their relationship to the study device or procedure.
|
100.0%
1/1 • Number of events 1 • Adverse events have been recorded starting from treatment up to 1 year follow up.
Adverse events have been recorded and categorized according to severity, relationship to procedure and relationship to device starting from treatment up to 1 year follow up. .All AEs has been assessed for their relationship to the study device or procedure.
|
0.00%
0/6 • Adverse events have been recorded starting from treatment up to 1 year follow up.
Adverse events have been recorded and categorized according to severity, relationship to procedure and relationship to device starting from treatment up to 1 year follow up. .All AEs has been assessed for their relationship to the study device or procedure.
|
Other adverse events
| Measure |
ExAblate Sham Treated Arm
n=1 participants at risk
ExAblate Transcranial System sham subthalamotomy for motor symptoms of Parkinson's Disease. Sham subjects completing the 4 Month visit may be offered the actual ExAblate subthalamotomy.
ExAblate Transcranial System: ExAblate Transcranial System subthalamotomy for symptoms of Parkinson's Disease
|
Crossover
n=1 participants at risk
Sham subjects completing the 4 Month visit whom crossover to the actual ExAblate subthalamotomy.
|
ExAblate Treated Arm
n=6 participants at risk
ExAblate Transcranial System subthalamotomy for motor symptoms of Parkinson's Disease.
ExAblate Transcranial System: ExAblate Transcranial System subthalamotomy for symptoms of Parkinson's Disease
|
|---|---|---|---|
|
Cardiac disorders
Vasovagal Syncope
|
0.00%
0/1 • Adverse events have been recorded starting from treatment up to 1 year follow up.
Adverse events have been recorded and categorized according to severity, relationship to procedure and relationship to device starting from treatment up to 1 year follow up. .All AEs has been assessed for their relationship to the study device or procedure.
|
0.00%
0/1 • Adverse events have been recorded starting from treatment up to 1 year follow up.
Adverse events have been recorded and categorized according to severity, relationship to procedure and relationship to device starting from treatment up to 1 year follow up. .All AEs has been assessed for their relationship to the study device or procedure.
|
33.3%
2/6 • Number of events 2 • Adverse events have been recorded starting from treatment up to 1 year follow up.
Adverse events have been recorded and categorized according to severity, relationship to procedure and relationship to device starting from treatment up to 1 year follow up. .All AEs has been assessed for their relationship to the study device or procedure.
|
|
Gastrointestinal disorders
Nausea/Vomiting
|
0.00%
0/1 • Adverse events have been recorded starting from treatment up to 1 year follow up.
Adverse events have been recorded and categorized according to severity, relationship to procedure and relationship to device starting from treatment up to 1 year follow up. .All AEs has been assessed for their relationship to the study device or procedure.
|
0.00%
0/1 • Adverse events have been recorded starting from treatment up to 1 year follow up.
Adverse events have been recorded and categorized according to severity, relationship to procedure and relationship to device starting from treatment up to 1 year follow up. .All AEs has been assessed for their relationship to the study device or procedure.
|
33.3%
2/6 • Number of events 2 • Adverse events have been recorded starting from treatment up to 1 year follow up.
Adverse events have been recorded and categorized according to severity, relationship to procedure and relationship to device starting from treatment up to 1 year follow up. .All AEs has been assessed for their relationship to the study device or procedure.
|
|
General disorders
Floating sensation
|
0.00%
0/1 • Adverse events have been recorded starting from treatment up to 1 year follow up.
Adverse events have been recorded and categorized according to severity, relationship to procedure and relationship to device starting from treatment up to 1 year follow up. .All AEs has been assessed for their relationship to the study device or procedure.
|
0.00%
0/1 • Adverse events have been recorded starting from treatment up to 1 year follow up.
Adverse events have been recorded and categorized according to severity, relationship to procedure and relationship to device starting from treatment up to 1 year follow up. .All AEs has been assessed for their relationship to the study device or procedure.
|
16.7%
1/6 • Number of events 1 • Adverse events have been recorded starting from treatment up to 1 year follow up.
Adverse events have been recorded and categorized according to severity, relationship to procedure and relationship to device starting from treatment up to 1 year follow up. .All AEs has been assessed for their relationship to the study device or procedure.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal weakness
|
0.00%
0/1 • Adverse events have been recorded starting from treatment up to 1 year follow up.
Adverse events have been recorded and categorized according to severity, relationship to procedure and relationship to device starting from treatment up to 1 year follow up. .All AEs has been assessed for their relationship to the study device or procedure.
|
0.00%
0/1 • Adverse events have been recorded starting from treatment up to 1 year follow up.
Adverse events have been recorded and categorized according to severity, relationship to procedure and relationship to device starting from treatment up to 1 year follow up. .All AEs has been assessed for their relationship to the study device or procedure.
|
33.3%
2/6 • Number of events 2 • Adverse events have been recorded starting from treatment up to 1 year follow up.
Adverse events have been recorded and categorized according to severity, relationship to procedure and relationship to device starting from treatment up to 1 year follow up. .All AEs has been assessed for their relationship to the study device or procedure.
|
|
Musculoskeletal and connective tissue disorders
Rib fracture
|
0.00%
0/1 • Adverse events have been recorded starting from treatment up to 1 year follow up.
Adverse events have been recorded and categorized according to severity, relationship to procedure and relationship to device starting from treatment up to 1 year follow up. .All AEs has been assessed for their relationship to the study device or procedure.
|
0.00%
0/1 • Adverse events have been recorded starting from treatment up to 1 year follow up.
Adverse events have been recorded and categorized according to severity, relationship to procedure and relationship to device starting from treatment up to 1 year follow up. .All AEs has been assessed for their relationship to the study device or procedure.
|
16.7%
1/6 • Number of events 1 • Adverse events have been recorded starting from treatment up to 1 year follow up.
Adverse events have been recorded and categorized according to severity, relationship to procedure and relationship to device starting from treatment up to 1 year follow up. .All AEs has been assessed for their relationship to the study device or procedure.
|
|
Musculoskeletal and connective tissue disorders
Fall
|
0.00%
0/1 • Adverse events have been recorded starting from treatment up to 1 year follow up.
Adverse events have been recorded and categorized according to severity, relationship to procedure and relationship to device starting from treatment up to 1 year follow up. .All AEs has been assessed for their relationship to the study device or procedure.
|
0.00%
0/1 • Adverse events have been recorded starting from treatment up to 1 year follow up.
Adverse events have been recorded and categorized according to severity, relationship to procedure and relationship to device starting from treatment up to 1 year follow up. .All AEs has been assessed for their relationship to the study device or procedure.
|
16.7%
1/6 • Number of events 1 • Adverse events have been recorded starting from treatment up to 1 year follow up.
Adverse events have been recorded and categorized according to severity, relationship to procedure and relationship to device starting from treatment up to 1 year follow up. .All AEs has been assessed for their relationship to the study device or procedure.
|
|
Surgical and medical procedures
Head pain (sonication related)
|
0.00%
0/1 • Adverse events have been recorded starting from treatment up to 1 year follow up.
Adverse events have been recorded and categorized according to severity, relationship to procedure and relationship to device starting from treatment up to 1 year follow up. .All AEs has been assessed for their relationship to the study device or procedure.
|
0.00%
0/1 • Adverse events have been recorded starting from treatment up to 1 year follow up.
Adverse events have been recorded and categorized according to severity, relationship to procedure and relationship to device starting from treatment up to 1 year follow up. .All AEs has been assessed for their relationship to the study device or procedure.
|
66.7%
4/6 • Number of events 6 • Adverse events have been recorded starting from treatment up to 1 year follow up.
Adverse events have been recorded and categorized according to severity, relationship to procedure and relationship to device starting from treatment up to 1 year follow up. .All AEs has been assessed for their relationship to the study device or procedure.
|
|
Surgical and medical procedures
Positional pain
|
0.00%
0/1 • Adverse events have been recorded starting from treatment up to 1 year follow up.
Adverse events have been recorded and categorized according to severity, relationship to procedure and relationship to device starting from treatment up to 1 year follow up. .All AEs has been assessed for their relationship to the study device or procedure.
|
0.00%
0/1 • Adverse events have been recorded starting from treatment up to 1 year follow up.
Adverse events have been recorded and categorized according to severity, relationship to procedure and relationship to device starting from treatment up to 1 year follow up. .All AEs has been assessed for their relationship to the study device or procedure.
|
16.7%
1/6 • Number of events 1 • Adverse events have been recorded starting from treatment up to 1 year follow up.
Adverse events have been recorded and categorized according to severity, relationship to procedure and relationship to device starting from treatment up to 1 year follow up. .All AEs has been assessed for their relationship to the study device or procedure.
|
|
Surgical and medical procedures
Sonication-related warmth
|
0.00%
0/1 • Adverse events have been recorded starting from treatment up to 1 year follow up.
Adverse events have been recorded and categorized according to severity, relationship to procedure and relationship to device starting from treatment up to 1 year follow up. .All AEs has been assessed for their relationship to the study device or procedure.
|
0.00%
0/1 • Adverse events have been recorded starting from treatment up to 1 year follow up.
Adverse events have been recorded and categorized according to severity, relationship to procedure and relationship to device starting from treatment up to 1 year follow up. .All AEs has been assessed for their relationship to the study device or procedure.
|
16.7%
1/6 • Number of events 1 • Adverse events have been recorded starting from treatment up to 1 year follow up.
Adverse events have been recorded and categorized according to severity, relationship to procedure and relationship to device starting from treatment up to 1 year follow up. .All AEs has been assessed for their relationship to the study device or procedure.
|
|
Surgical and medical procedures
Numbness/tingling
|
0.00%
0/1 • Adverse events have been recorded starting from treatment up to 1 year follow up.
Adverse events have been recorded and categorized according to severity, relationship to procedure and relationship to device starting from treatment up to 1 year follow up. .All AEs has been assessed for their relationship to the study device or procedure.
|
0.00%
0/1 • Adverse events have been recorded starting from treatment up to 1 year follow up.
Adverse events have been recorded and categorized according to severity, relationship to procedure and relationship to device starting from treatment up to 1 year follow up. .All AEs has been assessed for their relationship to the study device or procedure.
|
16.7%
1/6 • Number of events 2 • Adverse events have been recorded starting from treatment up to 1 year follow up.
Adverse events have been recorded and categorized according to severity, relationship to procedure and relationship to device starting from treatment up to 1 year follow up. .All AEs has been assessed for their relationship to the study device or procedure.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/1 • Adverse events have been recorded starting from treatment up to 1 year follow up.
Adverse events have been recorded and categorized according to severity, relationship to procedure and relationship to device starting from treatment up to 1 year follow up. .All AEs has been assessed for their relationship to the study device or procedure.
|
0.00%
0/1 • Adverse events have been recorded starting from treatment up to 1 year follow up.
Adverse events have been recorded and categorized according to severity, relationship to procedure and relationship to device starting from treatment up to 1 year follow up. .All AEs has been assessed for their relationship to the study device or procedure.
|
16.7%
1/6 • Number of events 1 • Adverse events have been recorded starting from treatment up to 1 year follow up.
Adverse events have been recorded and categorized according to severity, relationship to procedure and relationship to device starting from treatment up to 1 year follow up. .All AEs has been assessed for their relationship to the study device or procedure.
|
|
Ear and labyrinth disorders
Imbalance
|
0.00%
0/1 • Adverse events have been recorded starting from treatment up to 1 year follow up.
Adverse events have been recorded and categorized according to severity, relationship to procedure and relationship to device starting from treatment up to 1 year follow up. .All AEs has been assessed for their relationship to the study device or procedure.
|
0.00%
0/1 • Adverse events have been recorded starting from treatment up to 1 year follow up.
Adverse events have been recorded and categorized according to severity, relationship to procedure and relationship to device starting from treatment up to 1 year follow up. .All AEs has been assessed for their relationship to the study device or procedure.
|
16.7%
1/6 • Number of events 1 • Adverse events have been recorded starting from treatment up to 1 year follow up.
Adverse events have been recorded and categorized according to severity, relationship to procedure and relationship to device starting from treatment up to 1 year follow up. .All AEs has been assessed for their relationship to the study device or procedure.
|
|
Nervous system disorders
Ataxia
|
0.00%
0/1 • Adverse events have been recorded starting from treatment up to 1 year follow up.
Adverse events have been recorded and categorized according to severity, relationship to procedure and relationship to device starting from treatment up to 1 year follow up. .All AEs has been assessed for their relationship to the study device or procedure.
|
0.00%
0/1 • Adverse events have been recorded starting from treatment up to 1 year follow up.
Adverse events have been recorded and categorized according to severity, relationship to procedure and relationship to device starting from treatment up to 1 year follow up. .All AEs has been assessed for their relationship to the study device or procedure.
|
16.7%
1/6 • Number of events 1 • Adverse events have been recorded starting from treatment up to 1 year follow up.
Adverse events have been recorded and categorized according to severity, relationship to procedure and relationship to device starting from treatment up to 1 year follow up. .All AEs has been assessed for their relationship to the study device or procedure.
|
|
Nervous system disorders
Dyskinesia
|
0.00%
0/1 • Adverse events have been recorded starting from treatment up to 1 year follow up.
Adverse events have been recorded and categorized according to severity, relationship to procedure and relationship to device starting from treatment up to 1 year follow up. .All AEs has been assessed for their relationship to the study device or procedure.
|
0.00%
0/1 • Adverse events have been recorded starting from treatment up to 1 year follow up.
Adverse events have been recorded and categorized according to severity, relationship to procedure and relationship to device starting from treatment up to 1 year follow up. .All AEs has been assessed for their relationship to the study device or procedure.
|
16.7%
1/6 • Number of events 1 • Adverse events have been recorded starting from treatment up to 1 year follow up.
Adverse events have been recorded and categorized according to severity, relationship to procedure and relationship to device starting from treatment up to 1 year follow up. .All AEs has been assessed for their relationship to the study device or procedure.
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/1 • Adverse events have been recorded starting from treatment up to 1 year follow up.
Adverse events have been recorded and categorized according to severity, relationship to procedure and relationship to device starting from treatment up to 1 year follow up. .All AEs has been assessed for their relationship to the study device or procedure.
|
100.0%
1/1 • Number of events 1 • Adverse events have been recorded starting from treatment up to 1 year follow up.
Adverse events have been recorded and categorized according to severity, relationship to procedure and relationship to device starting from treatment up to 1 year follow up. .All AEs has been assessed for their relationship to the study device or procedure.
|
33.3%
2/6 • Number of events 2 • Adverse events have been recorded starting from treatment up to 1 year follow up.
Adverse events have been recorded and categorized according to severity, relationship to procedure and relationship to device starting from treatment up to 1 year follow up. .All AEs has been assessed for their relationship to the study device or procedure.
|
|
Nervous system disorders
Imbalance
|
0.00%
0/1 • Adverse events have been recorded starting from treatment up to 1 year follow up.
Adverse events have been recorded and categorized according to severity, relationship to procedure and relationship to device starting from treatment up to 1 year follow up. .All AEs has been assessed for their relationship to the study device or procedure.
|
0.00%
0/1 • Adverse events have been recorded starting from treatment up to 1 year follow up.
Adverse events have been recorded and categorized according to severity, relationship to procedure and relationship to device starting from treatment up to 1 year follow up. .All AEs has been assessed for their relationship to the study device or procedure.
|
16.7%
1/6 • Number of events 1 • Adverse events have been recorded starting from treatment up to 1 year follow up.
Adverse events have been recorded and categorized according to severity, relationship to procedure and relationship to device starting from treatment up to 1 year follow up. .All AEs has been assessed for their relationship to the study device or procedure.
|
|
Nervous system disorders
Sonication-related Vertigo
|
0.00%
0/1 • Adverse events have been recorded starting from treatment up to 1 year follow up.
Adverse events have been recorded and categorized according to severity, relationship to procedure and relationship to device starting from treatment up to 1 year follow up. .All AEs has been assessed for their relationship to the study device or procedure.
|
100.0%
1/1 • Number of events 1 • Adverse events have been recorded starting from treatment up to 1 year follow up.
Adverse events have been recorded and categorized according to severity, relationship to procedure and relationship to device starting from treatment up to 1 year follow up. .All AEs has been assessed for their relationship to the study device or procedure.
|
16.7%
1/6 • Number of events 1 • Adverse events have been recorded starting from treatment up to 1 year follow up.
Adverse events have been recorded and categorized according to severity, relationship to procedure and relationship to device starting from treatment up to 1 year follow up. .All AEs has been assessed for their relationship to the study device or procedure.
|
|
Nervous system disorders
Cognitive disturbance
|
0.00%
0/1 • Adverse events have been recorded starting from treatment up to 1 year follow up.
Adverse events have been recorded and categorized according to severity, relationship to procedure and relationship to device starting from treatment up to 1 year follow up. .All AEs has been assessed for their relationship to the study device or procedure.
|
0.00%
0/1 • Adverse events have been recorded starting from treatment up to 1 year follow up.
Adverse events have been recorded and categorized according to severity, relationship to procedure and relationship to device starting from treatment up to 1 year follow up. .All AEs has been assessed for their relationship to the study device or procedure.
|
16.7%
1/6 • Number of events 1 • Adverse events have been recorded starting from treatment up to 1 year follow up.
Adverse events have been recorded and categorized according to severity, relationship to procedure and relationship to device starting from treatment up to 1 year follow up. .All AEs has been assessed for their relationship to the study device or procedure.
|
|
Musculoskeletal and connective tissue disorders
Facial Weakness
|
0.00%
0/1 • Adverse events have been recorded starting from treatment up to 1 year follow up.
Adverse events have been recorded and categorized according to severity, relationship to procedure and relationship to device starting from treatment up to 1 year follow up. .All AEs has been assessed for their relationship to the study device or procedure.
|
100.0%
1/1 • Number of events 1 • Adverse events have been recorded starting from treatment up to 1 year follow up.
Adverse events have been recorded and categorized according to severity, relationship to procedure and relationship to device starting from treatment up to 1 year follow up. .All AEs has been assessed for their relationship to the study device or procedure.
|
0.00%
0/6 • Adverse events have been recorded starting from treatment up to 1 year follow up.
Adverse events have been recorded and categorized according to severity, relationship to procedure and relationship to device starting from treatment up to 1 year follow up. .All AEs has been assessed for their relationship to the study device or procedure.
|
|
Nervous system disorders
Falling
|
0.00%
0/1 • Adverse events have been recorded starting from treatment up to 1 year follow up.
Adverse events have been recorded and categorized according to severity, relationship to procedure and relationship to device starting from treatment up to 1 year follow up. .All AEs has been assessed for their relationship to the study device or procedure.
|
100.0%
1/1 • Number of events 1 • Adverse events have been recorded starting from treatment up to 1 year follow up.
Adverse events have been recorded and categorized according to severity, relationship to procedure and relationship to device starting from treatment up to 1 year follow up. .All AEs has been assessed for their relationship to the study device or procedure.
|
0.00%
0/6 • Adverse events have been recorded starting from treatment up to 1 year follow up.
Adverse events have been recorded and categorized according to severity, relationship to procedure and relationship to device starting from treatment up to 1 year follow up. .All AEs has been assessed for their relationship to the study device or procedure.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place