Trial Outcomes & Findings for Autonomic Neuromodulation by Transcutaneous Nerve Stimulation in Acute Ischaemic Stroke. (NCT NCT05417009)
NCT ID: NCT05417009
Last Updated: 2025-07-14
Results Overview
Coefficient of variation of systolic blood pressure
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
36 participants
Primary outcome timeframe
0-24h after mechanical thrombectomy
Results posted on
2025-07-14
Participant Flow
Patients referred for urgent mechanical thrombectomy.
Participant milestones
| Measure |
Stimulation - n=18
Electrodes attached bliaterally to tragus nerve region of outer ear, with appropriate device settings to deliver current.
trans-cutaneous auricular sensory stimulation: Transcutaneous auricular sensory stimulation
|
Electrode Attachment Only - n=18
Electrodes attached bliaterally to tragus nerve region of outer ear, with device switched off \[blinded to operator\].
trans-cutaneous auricular sensory stimulation: Transcutaneous auricular sensory stimulation
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
18
|
|
Overall Study
COMPLETED
|
18
|
18
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Autonomic Neuromodulation by Transcutaneous Nerve Stimulation in Acute Ischaemic Stroke.
Baseline characteristics by cohort
| Measure |
Stimulation - n=18
n=18 Participants
Electrodes attached bilaterally to tragus nerve region of outer ear, with appropriate device settings to deliver current.
trans-cutaneous auricular sensory stimulation: Transcutaneous auricular sensory stimulation
|
Electrode Attachment Only - n=18
n=18 Participants
Electrodes attached bilaterally to tragus nerve region of outer ear, with device switched off \[blinded to operator\].
trans-cutaneous auricular sensory stimulation: Transcutaneous auricular sensory stimulation
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
11 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Age, Continuous
|
69 years
STANDARD_DEVIATION 13 • n=99 Participants
|
69 years
STANDARD_DEVIATION 15 • n=107 Participants
|
69 years
STANDARD_DEVIATION 14 • n=206 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Non-white
|
8 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
10 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
|
Region of Enrollment
United Kingdom
|
18 participants
n=99 Participants
|
18 participants
n=107 Participants
|
36 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 0-24h after mechanical thrombectomyCoefficient of variation of systolic blood pressure
Outcome measures
| Measure |
Stimulation
n=18 Participants
Electrodes attached bliaterally to tragus nerve region of outer ear, with appropriate device settings to deliver current.
trans-cutaneous auricular sensory stimulation: Transcutaneous auricular sensory stimulation
|
Electrode Attachment Only.
n=18 Participants
Electrodes attached bliaterally to tragus nerve region of outer ear, with device switched off \[blinded to operator\].
trans-cutaneous auricular sensory stimulation: Transcutaneous auricular sensory stimulation
|
|---|---|---|
|
Blood Pressure Variability
|
0.106 coefficient of variation
Standard Deviation 0.029
|
0.107 coefficient of variation
Standard Deviation 0.027
|
SECONDARY outcome
Timeframe: 0-24h after mechanical thrombectomySystolic blood pressure standard deviation.
Outcome measures
| Measure |
Stimulation
n=18 Participants
Electrodes attached bliaterally to tragus nerve region of outer ear, with appropriate device settings to deliver current.
trans-cutaneous auricular sensory stimulation: Transcutaneous auricular sensory stimulation
|
Electrode Attachment Only.
n=18 Participants
Electrodes attached bliaterally to tragus nerve region of outer ear, with device switched off \[blinded to operator\].
trans-cutaneous auricular sensory stimulation: Transcutaneous auricular sensory stimulation
|
|---|---|---|
|
Systolic Blood Pressure Variability.
|
14 mmHg
Standard Deviation 5
|
14 mmHg
Standard Deviation 4
|
SECONDARY outcome
Timeframe: 24h after admission for mechanical thrombectomycoefficient of variation- diastolic blood pressure
Outcome measures
| Measure |
Stimulation
n=18 Participants
Electrodes attached bliaterally to tragus nerve region of outer ear, with appropriate device settings to deliver current.
trans-cutaneous auricular sensory stimulation: Transcutaneous auricular sensory stimulation
|
Electrode Attachment Only.
n=18 Participants
Electrodes attached bliaterally to tragus nerve region of outer ear, with device switched off \[blinded to operator\].
trans-cutaneous auricular sensory stimulation: Transcutaneous auricular sensory stimulation
|
|---|---|---|
|
Diastolic Blood Pressure Variability
|
0.136 coefficient of variation
Standard Deviation 0.05
|
0.127 coefficient of variation
Standard Deviation 0.04
|
Adverse Events
Stimulation - n=18
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Electrode Attachment Only - n=18
Serious events: 0 serious events
Other events: 0 other events
Deaths: 2 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Stimulation - n=18
n=18 participants at risk
Electrodes attached bliaterally to tragus nerve region of outer ear, with appropriate device settings to deliver current.
trans-cutaneous auricular sensory stimulation: Transcutaneous auricular sensory stimulation
|
Electrode Attachment Only - n=18
n=18 participants at risk
Electrodes attached bliaterally to tragus nerve region of outer ear, with device switched off \[blinded to operator\].
trans-cutaneous auricular sensory stimulation: Transcutaneous auricular sensory stimulation
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
5.6%
1/18 • Number of events 1 • From randomisation until 7 days after thrombectomy
Daily assessment while in hospital
|
0.00%
0/18 • From randomisation until 7 days after thrombectomy
Daily assessment while in hospital
|
|
Respiratory, thoracic and mediastinal disorders
Anaesthetic complication
|
5.6%
1/18 • Number of events 1 • From randomisation until 7 days after thrombectomy
Daily assessment while in hospital
|
0.00%
0/18 • From randomisation until 7 days after thrombectomy
Daily assessment while in hospital
|
Additional Information
Professor Gareth Ackland
Queen Mary University of London
Phone: 02035940348
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place