Trial Outcomes & Findings for fMRI Guided TMS Enhancement of Associative Memory Networks (NCT NCT02749422)
NCT ID: NCT02749422
Last Updated: 2024-05-29
Results Overview
A face-object pair association task will be administered before and after rTMS treatment at each treatment session. This measure is evaluating the mean change in the task score from immediately before rTMS is applied to the left lateral parietal site to immediately after treatment.
TERMINATED
NA
8 participants
Immediately before Left Lateral Parietal Site Stimulation, Immediately after Left Lateral Parietal Site Stimulation (20 minute procedure; Up to Week 6)
2024-05-29
Participant Flow
No patients were enrolled in the Healthy Subjects arm.
Participant milestones
| Measure |
Healthy Subjects
MagStim RapidStim2: Repetitive transcranial magnetic stimulation (TMS)
|
Temporal Lobe Epilepsy Patients
MagStim RapidStim2: Repetitive transcranial magnetic stimulation (TMS)
|
|---|---|---|
|
Overall Study
STARTED
|
0
|
8
|
|
Overall Study
COMPLETED
|
0
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
3
|
Reasons for withdrawal
| Measure |
Healthy Subjects
MagStim RapidStim2: Repetitive transcranial magnetic stimulation (TMS)
|
Temporal Lobe Epilepsy Patients
MagStim RapidStim2: Repetitive transcranial magnetic stimulation (TMS)
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
|
Overall Study
Ineligible
|
0
|
1
|
Baseline Characteristics
fMRI Guided TMS Enhancement of Associative Memory Networks
Baseline characteristics by cohort
| Measure |
Healthy Subjects
MagStim RapidStim2: Repetitive transcranial magnetic stimulation (TMS)
|
Temporal Lobe Epilepsy Patients
n=5 Participants
MagStim RapidStim2: Repetitive transcranial magnetic stimulation (TMS)
|
Total
n=5 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
—
|
26.6 years
STANDARD_DEVIATION 7.3 • n=107 Participants
|
26.6 years
STANDARD_DEVIATION 7.3 • n=206 Participants
|
|
Sex: Female, Male
Female
|
—
|
4 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
—
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
—
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
—
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
—
|
4 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
—
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
—
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
—
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
—
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
—
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
—
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
—
|
4 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
—
|
5 participants
n=107 Participants
|
5 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Immediately before Left Lateral Parietal Site Stimulation, Immediately after Left Lateral Parietal Site Stimulation (20 minute procedure; Up to Week 6)Population: Data for this outcome measure were not collected from participants in the study.
A face-object pair association task will be administered before and after rTMS treatment at each treatment session. This measure is evaluating the mean change in the task score from immediately before rTMS is applied to the left lateral parietal site to immediately after treatment.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Immediately before Motor Cortex Stimulation, Immediately after Motor Cortex Stimulation (20 minute procedure; Up to Week 6)Population: Data for this outcome measure were not collected from participants in the study.
A face-object pair association task will be administered before and after rTMS treatment at each treatment session. This measure is evaluating the mean change in the task score from immediately before rTMS is applied to the motor cortex to immediately after treatment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week 6Population: Data for this outcome measure were not collected from participants in the study.
Changes in hippocampal-cortical functional connectivity will be identified using voxel-wise paired T-tests. The change will be measured between baseline assessment and resting state fMRI assessment following rTMS.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Immediately before Left Lateral Parietal Site Stimulation, Immediately after Left Lateral Parietal Site Stimulation (20 minute procedure; Up to Week 6)Population: Data for this outcome measure were not collected from participants in the study.
A word-pair association task will be administered before and after rTMS treatment at each treatment session. This measure is evaluating the mean change in the task score from immediately before rTMS is applied to the left lateral parietal site to immediately after treatment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Immediately before Motor Cortex Stimulation, Immediately after Motor Cortex Stimulation (20 minute procedure; Up to Week 6)Population: Data for this outcome measure were not collected from participants in the study.
A word-pair association task will be administered before and after rTMS treatment at each treatment session. This measure is evaluating the mean change in the task score from immediately before rTMS is applied to the motor cortex to immediately after treatment.
Outcome measures
Outcome data not reported
Adverse Events
Healthy Subjects
Temporal Lobe Epilepsy Patients
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place