Trial Outcomes & Findings for Multifocal Brain Magnetic Stimulation in Chronic Ischemic Stroke (NCT NCT02817087)
NCT ID: NCT02817087
Last Updated: 2020-10-05
Results Overview
Change in number of active voxels in the cortical areas surrounding the lesion on functional MRI
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
38 participants
Primary outcome timeframe
One business day before treatment begins, one business day after treatment ends, up to 5 weeks
Results posted on
2020-10-05
Participant Flow
38 patients were screened 7 were screen fails. 2 withdrawn. 14 treated-Active, 15 treated-placebo.
Participant milestones
| Measure |
Repetitive Transcranial Magnetic Stimulation -On
Participants wear the repetitive transcranial magnetic stimulation (rTMS) cap delivering magnetic stimulation to part of the brain.
repetitive Transcranial Magnetic Stimulation -On: Cap worn on the scalp will deliver active Repetitive Transcranial Magnetic Stimulation to specific parts of the brain
|
Repetitive Transcranial Magnetic Stimulation -Off
Participants wear the repetitive transcranial magnetic stimulation (rTMS) cap that does NOT delivery any magnetic stimulation to the brain.
repetitive Transcranial Magnetic Stimulation -Off: Cap worn on the scalp will no delivery of the Repetitive Transcranial Magnetic Stimulation to any part of the, referred to as a sham or inactive study treatment.
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
15
|
|
Overall Study
COMPLETED
|
14
|
15
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Repetitive Transcranial Magnetic Stimulation -On
Participants wear the repetitive transcranial magnetic stimulation (rTMS) cap delivering magnetic stimulation to part of the brain.
repetitive Transcranial Magnetic Stimulation -On: Cap worn on the scalp will deliver active Repetitive Transcranial Magnetic Stimulation to specific parts of the brain
|
Repetitive Transcranial Magnetic Stimulation -Off
Participants wear the repetitive transcranial magnetic stimulation (rTMS) cap that does NOT delivery any magnetic stimulation to the brain.
repetitive Transcranial Magnetic Stimulation -Off: Cap worn on the scalp will no delivery of the Repetitive Transcranial Magnetic Stimulation to any part of the, referred to as a sham or inactive study treatment.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
Baseline Characteristics
1 pt was withdrawn early d/t concurrent disease. One pt. withdrew ICF d/t transportation concerns
Baseline characteristics by cohort
| Measure |
Repetitive Transcranial Magnetic Stimulation -On
n=16 Participants
Participants wear the repetitive transcranial magnetic stimulation (rTMS) cap delivering magnetic stimulation to part of the brain.
repetitive Transcranial Magnetic Stimulation -On: Cap worn on the scalp will deliver active Repetitive Transcranial Magnetic Stimulation to specific parts of the brain
|
Repetitive Transcranial Magnetic Stimulation -Off
n=15 Participants
Participants wear the repetitive transcranial magnetic stimulation (rTMS) cap that does NOT delivery any magnetic stimulation to the brain.
repetitive Transcranial Magnetic Stimulation -Off: Cap worn on the scalp will no delivery of the Repetitive Transcranial Magnetic Stimulation to any part of the, referred to as a sham or inactive study treatment.
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=14 Participants • 1 pt was withdrawn early d/t concurrent disease. One pt. withdrew ICF d/t transportation concerns
|
0 Participants
n=15 Participants • 1 pt was withdrawn early d/t concurrent disease. One pt. withdrew ICF d/t transportation concerns
|
0 Participants
n=29 Participants • 1 pt was withdrawn early d/t concurrent disease. One pt. withdrew ICF d/t transportation concerns
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=14 Participants • 1 pt was withdrawn early d/t concurrent disease. One pt. withdrew ICF d/t transportation concerns
|
7 Participants
n=15 Participants • 1 pt was withdrawn early d/t concurrent disease. One pt. withdrew ICF d/t transportation concerns
|
13 Participants
n=29 Participants • 1 pt was withdrawn early d/t concurrent disease. One pt. withdrew ICF d/t transportation concerns
|
|
Age, Categorical
>=65 years
|
8 Participants
n=14 Participants • 1 pt was withdrawn early d/t concurrent disease. One pt. withdrew ICF d/t transportation concerns
|
8 Participants
n=15 Participants • 1 pt was withdrawn early d/t concurrent disease. One pt. withdrew ICF d/t transportation concerns
|
16 Participants
n=29 Participants • 1 pt was withdrawn early d/t concurrent disease. One pt. withdrew ICF d/t transportation concerns
|
|
Age, Continuous
|
65.4 years
n=14 Participants • 1 pt was withdrawn early d/t concurrent disease. One pt. withdrew ICF d/t transportation concerns
|
66.3 years
n=15 Participants • 1 pt was withdrawn early d/t concurrent disease. One pt. withdrew ICF d/t transportation concerns
|
65.8 years
n=29 Participants • 1 pt was withdrawn early d/t concurrent disease. One pt. withdrew ICF d/t transportation concerns
|
|
Sex: Female, Male
Female
|
6 Participants
n=14 Participants • 1 pt was withdrawn early d/t concurrent disease. One pt. withdrew ICF d/t transportation concerns
|
9 Participants
n=15 Participants • 1 pt was withdrawn early d/t concurrent disease. One pt. withdrew ICF d/t transportation concerns
|
15 Participants
n=29 Participants • 1 pt was withdrawn early d/t concurrent disease. One pt. withdrew ICF d/t transportation concerns
|
|
Sex: Female, Male
Male
|
8 Participants
n=14 Participants • 1 pt was withdrawn early d/t concurrent disease. One pt. withdrew ICF d/t transportation concerns
|
6 Participants
n=15 Participants • 1 pt was withdrawn early d/t concurrent disease. One pt. withdrew ICF d/t transportation concerns
|
14 Participants
n=29 Participants • 1 pt was withdrawn early d/t concurrent disease. One pt. withdrew ICF d/t transportation concerns
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=14 Participants • pt was withdrawn early d/t concurrent disease. One pt. withdrew ICF d/t transportation concerns
|
1 Participants
n=15 Participants • pt was withdrawn early d/t concurrent disease. One pt. withdrew ICF d/t transportation concerns
|
3 Participants
n=29 Participants • pt was withdrawn early d/t concurrent disease. One pt. withdrew ICF d/t transportation concerns
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=14 Participants • pt was withdrawn early d/t concurrent disease. One pt. withdrew ICF d/t transportation concerns
|
14 Participants
n=15 Participants • pt was withdrawn early d/t concurrent disease. One pt. withdrew ICF d/t transportation concerns
|
26 Participants
n=29 Participants • pt was withdrawn early d/t concurrent disease. One pt. withdrew ICF d/t transportation concerns
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=14 Participants • pt was withdrawn early d/t concurrent disease. One pt. withdrew ICF d/t transportation concerns
|
0 Participants
n=15 Participants • pt was withdrawn early d/t concurrent disease. One pt. withdrew ICF d/t transportation concerns
|
0 Participants
n=29 Participants • pt was withdrawn early d/t concurrent disease. One pt. withdrew ICF d/t transportation concerns
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=14 Participants • pt was withdrawn early d/t concurrent disease. One pt. withdrew ICF d/t transportation concerns
|
0 Participants
n=15 Participants • pt was withdrawn early d/t concurrent disease. One pt. withdrew ICF d/t transportation concerns
|
0 Participants
n=29 Participants • pt was withdrawn early d/t concurrent disease. One pt. withdrew ICF d/t transportation concerns
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=14 Participants • pt was withdrawn early d/t concurrent disease. One pt. withdrew ICF d/t transportation concerns
|
0 Participants
n=15 Participants • pt was withdrawn early d/t concurrent disease. One pt. withdrew ICF d/t transportation concerns
|
1 Participants
n=29 Participants • pt was withdrawn early d/t concurrent disease. One pt. withdrew ICF d/t transportation concerns
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=14 Participants • pt was withdrawn early d/t concurrent disease. One pt. withdrew ICF d/t transportation concerns
|
0 Participants
n=15 Participants • pt was withdrawn early d/t concurrent disease. One pt. withdrew ICF d/t transportation concerns
|
0 Participants
n=29 Participants • pt was withdrawn early d/t concurrent disease. One pt. withdrew ICF d/t transportation concerns
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=14 Participants • pt was withdrawn early d/t concurrent disease. One pt. withdrew ICF d/t transportation concerns
|
0 Participants
n=15 Participants • pt was withdrawn early d/t concurrent disease. One pt. withdrew ICF d/t transportation concerns
|
3 Participants
n=29 Participants • pt was withdrawn early d/t concurrent disease. One pt. withdrew ICF d/t transportation concerns
|
|
Race (NIH/OMB)
White
|
10 Participants
n=14 Participants • pt was withdrawn early d/t concurrent disease. One pt. withdrew ICF d/t transportation concerns
|
15 Participants
n=15 Participants • pt was withdrawn early d/t concurrent disease. One pt. withdrew ICF d/t transportation concerns
|
25 Participants
n=29 Participants • pt was withdrawn early d/t concurrent disease. One pt. withdrew ICF d/t transportation concerns
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=14 Participants • pt was withdrawn early d/t concurrent disease. One pt. withdrew ICF d/t transportation concerns
|
0 Participants
n=15 Participants • pt was withdrawn early d/t concurrent disease. One pt. withdrew ICF d/t transportation concerns
|
0 Participants
n=29 Participants • pt was withdrawn early d/t concurrent disease. One pt. withdrew ICF d/t transportation concerns
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=14 Participants • pt was withdrawn early d/t concurrent disease. One pt. withdrew ICF d/t transportation concerns
|
0 Participants
n=15 Participants • pt was withdrawn early d/t concurrent disease. One pt. withdrew ICF d/t transportation concerns
|
0 Participants
n=29 Participants • pt was withdrawn early d/t concurrent disease. One pt. withdrew ICF d/t transportation concerns
|
|
Region of Enrollment
United States
|
14 participants
n=14 Participants • 1 pt was withdrawn early d/t concurrent disease. One pt. withdrew ICF d/t transportation concerns
|
15 participants
n=15 Participants • 1 pt was withdrawn early d/t concurrent disease. One pt. withdrew ICF d/t transportation concerns
|
29 participants
n=29 Participants • 1 pt was withdrawn early d/t concurrent disease. One pt. withdrew ICF d/t transportation concerns
|
|
Fugl-Meyer motor arm score
|
43 score on a scale
n=14 Participants • 1 pt was withdrawn early d/t concurrent disease. One pt. withdrew ICF d/t transportation concerns
|
25 score on a scale
n=15 Participants • 1 pt was withdrawn early d/t concurrent disease. One pt. withdrew ICF d/t transportation concerns
|
37.0 score on a scale
n=29 Participants • 1 pt was withdrawn early d/t concurrent disease. One pt. withdrew ICF d/t transportation concerns
|
|
National Institutes of Health Stroke Scale (NIHSS)
|
3 score on a scale
n=14 Participants • 1 pt was withdrawn early d/t concurrent disease. One pt. withdrew ICF d/t transportation concerns
|
3 score on a scale
n=15 Participants • 1 pt was withdrawn early d/t concurrent disease. One pt. withdrew ICF d/t transportation concerns
|
3.0 score on a scale
n=29 Participants • 1 pt was withdrawn early d/t concurrent disease. One pt. withdrew ICF d/t transportation concerns
|
|
Action Research Arm Test (ARAT)
|
29 score on a scale
n=14 Participants • 1 pt was withdrawn early d/t concurrent disease. One pt. withdrew ICF d/t transportation concerns
|
6 score on a scale
n=15 Participants • 1 pt was withdrawn early d/t concurrent disease. One pt. withdrew ICF d/t transportation concerns
|
14.0 score on a scale
n=29 Participants • 1 pt was withdrawn early d/t concurrent disease. One pt. withdrew ICF d/t transportation concerns
|
|
Hand Grip Strength
|
19.7 Pounds
n=14 Participants • 1 pt was withdrawn early d/t concurrent disease. One pt. withdrew ICF d/t transportation concerns
|
30.6 Pounds
n=15 Participants • 1 pt was withdrawn early d/t concurrent disease. One pt. withdrew ICF d/t transportation concerns
|
21.8 Pounds
n=29 Participants • 1 pt was withdrawn early d/t concurrent disease. One pt. withdrew ICF d/t transportation concerns
|
|
Pinch Strength
|
6.5 Pounds
n=14 Participants • 1 pt was withdrawn early d/t concurrent disease. One pt. withdrew ICF d/t transportation concerns
|
3.83 Pounds
n=15 Participants • 1 pt was withdrawn early d/t concurrent disease. One pt. withdrew ICF d/t transportation concerns
|
4.7 Pounds
n=29 Participants • 1 pt was withdrawn early d/t concurrent disease. One pt. withdrew ICF d/t transportation concerns
|
|
Gait velocity on Timed Up and Go Test
|
1.32 feet per second
n=14 Participants • 1 pt was withdrawn early d/t concurrent disease. One pt. withdrew ICF d/t transportation concerns
|
1.45 feet per second
n=15 Participants • 1 pt was withdrawn early d/t concurrent disease. One pt. withdrew ICF d/t transportation concerns
|
1.45 feet per second
n=29 Participants • 1 pt was withdrawn early d/t concurrent disease. One pt. withdrew ICF d/t transportation concerns
|
PRIMARY outcome
Timeframe: One business day before treatment begins, one business day after treatment ends, up to 5 weeksChange in number of active voxels in the cortical areas surrounding the lesion on functional MRI
Outcome measures
| Measure |
Repetitive Transcranial Magnetic Stimulation -On
n=14 Participants
Participants wear the repetitive transcranial magnetic stimulation (rTMS) cap delivering magnetic stimulation to part of the brain.
repetitive Transcranial Magnetic Stimulation -On: Cap worn on the scalp will deliver active Repetitive Transcranial Magnetic Stimulation to specific parts of the brain
|
Repetitive Transcranial Magnetic Stimulation -Off
n=15 Participants
Participants wear the repetitive transcranial magnetic stimulation (rTMS) cap that does NOT delivery any magnetic stimulation to the brain.
repetitive Transcranial Magnetic Stimulation -Off: Cap worn on the scalp will no delivery of the Repetitive Transcranial Magnetic Stimulation to any part of the, referred to as a sham or inactive study treatment.
|
|---|---|---|
|
Changes in Brain Activation
|
48.5 voxels
Interval -60.0 to 81.0
|
-30 voxels
Interval -373.3 to 0.0
|
SECONDARY outcome
Timeframe: One business day before treatment begins, one business day after treatment ends up to 5 weeksChange in arm motor function Total score range is 0-66 with the higher number representing a better outcome
Outcome measures
| Measure |
Repetitive Transcranial Magnetic Stimulation -On
n=14 Participants
Participants wear the repetitive transcranial magnetic stimulation (rTMS) cap delivering magnetic stimulation to part of the brain.
repetitive Transcranial Magnetic Stimulation -On: Cap worn on the scalp will deliver active Repetitive Transcranial Magnetic Stimulation to specific parts of the brain
|
Repetitive Transcranial Magnetic Stimulation -Off
n=15 Participants
Participants wear the repetitive transcranial magnetic stimulation (rTMS) cap that does NOT delivery any magnetic stimulation to the brain.
repetitive Transcranial Magnetic Stimulation -Off: Cap worn on the scalp will no delivery of the Repetitive Transcranial Magnetic Stimulation to any part of the, referred to as a sham or inactive study treatment.
|
|---|---|---|
|
Fugl-Meyer Motor Arm Score
|
2.5 score on a scale
Interval 0.0 to 6.0
|
2.0 score on a scale
Interval -1.0 to 8.0
|
SECONDARY outcome
Timeframe: One business day before treatment begins, one business day after treatment ends up to 5 weeksPopulation: Stroke patients greater than 3 months from qualifying stroke date
Change in arm and hand motor function Total score range is 0-57 with the higher number representing a better outcome
Outcome measures
| Measure |
Repetitive Transcranial Magnetic Stimulation -On
n=14 Participants
Participants wear the repetitive transcranial magnetic stimulation (rTMS) cap delivering magnetic stimulation to part of the brain.
repetitive Transcranial Magnetic Stimulation -On: Cap worn on the scalp will deliver active Repetitive Transcranial Magnetic Stimulation to specific parts of the brain
|
Repetitive Transcranial Magnetic Stimulation -Off
n=15 Participants
Participants wear the repetitive transcranial magnetic stimulation (rTMS) cap that does NOT delivery any magnetic stimulation to the brain.
repetitive Transcranial Magnetic Stimulation -Off: Cap worn on the scalp will no delivery of the Repetitive Transcranial Magnetic Stimulation to any part of the, referred to as a sham or inactive study treatment.
|
|---|---|---|
|
ARAT (Action Research Arm Test)
|
0 score on a scale
Interval 0.0 to 3.0
|
0 score on a scale
Interval 0.0 to 4.0
|
SECONDARY outcome
Timeframe: One business day before treatment begins, one business day after treatment ends up to 5 weeksChange in grip strength The higher the number represents better outcome
Outcome measures
| Measure |
Repetitive Transcranial Magnetic Stimulation -On
n=14 Participants
Participants wear the repetitive transcranial magnetic stimulation (rTMS) cap delivering magnetic stimulation to part of the brain.
repetitive Transcranial Magnetic Stimulation -On: Cap worn on the scalp will deliver active Repetitive Transcranial Magnetic Stimulation to specific parts of the brain
|
Repetitive Transcranial Magnetic Stimulation -Off
n=15 Participants
Participants wear the repetitive transcranial magnetic stimulation (rTMS) cap that does NOT delivery any magnetic stimulation to the brain.
repetitive Transcranial Magnetic Stimulation -Off: Cap worn on the scalp will no delivery of the Repetitive Transcranial Magnetic Stimulation to any part of the, referred to as a sham or inactive study treatment.
|
|---|---|---|
|
Hand Dynamometer
|
1.8 pounds
Interval 0.0 to 4.9
|
0 pounds
Interval -2.2 to 2.2
|
SECONDARY outcome
Timeframe: One business day before treatment begins, one business day after treatment ends up to 5 weeksChange in pinch strength. The higher the number, the better the outcome.
Outcome measures
| Measure |
Repetitive Transcranial Magnetic Stimulation -On
n=14 Participants
Participants wear the repetitive transcranial magnetic stimulation (rTMS) cap delivering magnetic stimulation to part of the brain.
repetitive Transcranial Magnetic Stimulation -On: Cap worn on the scalp will deliver active Repetitive Transcranial Magnetic Stimulation to specific parts of the brain
|
Repetitive Transcranial Magnetic Stimulation -Off
n=15 Participants
Participants wear the repetitive transcranial magnetic stimulation (rTMS) cap that does NOT delivery any magnetic stimulation to the brain.
repetitive Transcranial Magnetic Stimulation -Off: Cap worn on the scalp will no delivery of the Repetitive Transcranial Magnetic Stimulation to any part of the, referred to as a sham or inactive study treatment.
|
|---|---|---|
|
Pinch Dynamometer Score
|
.17 pounds
Interval 0.0 to 0.67
|
.33 pounds
Interval 0.0 to 0.83
|
SECONDARY outcome
Timeframe: One business day before treatment begins, one business day after treatment ends up to 5 weeksChange in gait velocity on Timed Up and Go Test. The lower the time recorded, the better the outcome.
Outcome measures
| Measure |
Repetitive Transcranial Magnetic Stimulation -On
n=14 Participants
Participants wear the repetitive transcranial magnetic stimulation (rTMS) cap delivering magnetic stimulation to part of the brain.
repetitive Transcranial Magnetic Stimulation -On: Cap worn on the scalp will deliver active Repetitive Transcranial Magnetic Stimulation to specific parts of the brain
|
Repetitive Transcranial Magnetic Stimulation -Off
n=15 Participants
Participants wear the repetitive transcranial magnetic stimulation (rTMS) cap that does NOT delivery any magnetic stimulation to the brain.
repetitive Transcranial Magnetic Stimulation -Off: Cap worn on the scalp will no delivery of the Repetitive Transcranial Magnetic Stimulation to any part of the, referred to as a sham or inactive study treatment.
|
|---|---|---|
|
TUG (Timed Up and Go Test)
|
.04 feet per second
Interval 0.0 to 0.11
|
0 feet per second
Interval -0.11 to 0.12
|
SECONDARY outcome
Timeframe: One business day before treatment begins, one business day after treatment ends up to 5 weeksChange in National Institutes of Health Stroke Scale (NIHSS) Total score range is 0-42 with the lower number representing a better outcome
Outcome measures
| Measure |
Repetitive Transcranial Magnetic Stimulation -On
n=14 Participants
Participants wear the repetitive transcranial magnetic stimulation (rTMS) cap delivering magnetic stimulation to part of the brain.
repetitive Transcranial Magnetic Stimulation -On: Cap worn on the scalp will deliver active Repetitive Transcranial Magnetic Stimulation to specific parts of the brain
|
Repetitive Transcranial Magnetic Stimulation -Off
n=15 Participants
Participants wear the repetitive transcranial magnetic stimulation (rTMS) cap that does NOT delivery any magnetic stimulation to the brain.
repetitive Transcranial Magnetic Stimulation -Off: Cap worn on the scalp will no delivery of the Repetitive Transcranial Magnetic Stimulation to any part of the, referred to as a sham or inactive study treatment.
|
|---|---|---|
|
National Institutes of Health Stroke Scale (NIHSS)
|
0 score on a scale
Interval -1.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
Adverse Events
Repetitive Transcranial Magnetic Stimulation -On
Serious events: 2 serious events
Other events: 1 other events
Deaths: 0 deaths
Repetitive Transcranial Magnetic Stimulation -Off
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Repetitive Transcranial Magnetic Stimulation -On
n=16 participants at risk
Participants wear the repetitive transcranial magnetic stimulation (rTMS) cap delivering magnetic stimulation to part of the brain.
repetitive Transcranial Magnetic Stimulation -On: Cap worn on the scalp will deliver active Repetitive Transcranial Magnetic Stimulation to specific parts of the brain
|
Repetitive Transcranial Magnetic Stimulation -Off
n=15 participants at risk
Participants wear the repetitive transcranial magnetic stimulation (rTMS) cap that does NOT delivery any magnetic stimulation to the brain.
repetitive Transcranial Magnetic Stimulation -Off: Cap worn on the scalp will no delivery of the Repetitive Transcranial Magnetic Stimulation to any part of the, referred to as a sham or inactive study treatment.
|
|---|---|---|
|
Nervous system disorders
Acute Ischemic Stroke
|
6.2%
1/16 • Number of events 1 • Adverse events were captured from time of first treatment to completion of the final visit at 3 months post treatment. Serious adverse events were captured from time of informed consent to completion of the final visit at 3 months post treatment.
All reported events were assessed by the Principal Investigator and resulted in no withdrawals due to study treatment
|
0.00%
0/15 • Adverse events were captured from time of first treatment to completion of the final visit at 3 months post treatment. Serious adverse events were captured from time of informed consent to completion of the final visit at 3 months post treatment.
All reported events were assessed by the Principal Investigator and resulted in no withdrawals due to study treatment
|
|
Renal and urinary disorders
Urinary tract infection
|
6.2%
1/16 • Number of events 1 • Adverse events were captured from time of first treatment to completion of the final visit at 3 months post treatment. Serious adverse events were captured from time of informed consent to completion of the final visit at 3 months post treatment.
All reported events were assessed by the Principal Investigator and resulted in no withdrawals due to study treatment
|
0.00%
0/15 • Adverse events were captured from time of first treatment to completion of the final visit at 3 months post treatment. Serious adverse events were captured from time of informed consent to completion of the final visit at 3 months post treatment.
All reported events were assessed by the Principal Investigator and resulted in no withdrawals due to study treatment
|
|
Nervous system disorders
Migraine
|
0.00%
0/16 • Adverse events were captured from time of first treatment to completion of the final visit at 3 months post treatment. Serious adverse events were captured from time of informed consent to completion of the final visit at 3 months post treatment.
All reported events were assessed by the Principal Investigator and resulted in no withdrawals due to study treatment
|
6.7%
1/15 • Number of events 1 • Adverse events were captured from time of first treatment to completion of the final visit at 3 months post treatment. Serious adverse events were captured from time of informed consent to completion of the final visit at 3 months post treatment.
All reported events were assessed by the Principal Investigator and resulted in no withdrawals due to study treatment
|
|
Renal and urinary disorders
Renal stone
|
0.00%
0/16 • Adverse events were captured from time of first treatment to completion of the final visit at 3 months post treatment. Serious adverse events were captured from time of informed consent to completion of the final visit at 3 months post treatment.
All reported events were assessed by the Principal Investigator and resulted in no withdrawals due to study treatment
|
6.7%
1/15 • Number of events 1 • Adverse events were captured from time of first treatment to completion of the final visit at 3 months post treatment. Serious adverse events were captured from time of informed consent to completion of the final visit at 3 months post treatment.
All reported events were assessed by the Principal Investigator and resulted in no withdrawals due to study treatment
|
|
Nervous system disorders
Seizure
|
6.2%
1/16 • Number of events 1 • Adverse events were captured from time of first treatment to completion of the final visit at 3 months post treatment. Serious adverse events were captured from time of informed consent to completion of the final visit at 3 months post treatment.
All reported events were assessed by the Principal Investigator and resulted in no withdrawals due to study treatment
|
0.00%
0/15 • Adverse events were captured from time of first treatment to completion of the final visit at 3 months post treatment. Serious adverse events were captured from time of informed consent to completion of the final visit at 3 months post treatment.
All reported events were assessed by the Principal Investigator and resulted in no withdrawals due to study treatment
|
Other adverse events
| Measure |
Repetitive Transcranial Magnetic Stimulation -On
n=16 participants at risk
Participants wear the repetitive transcranial magnetic stimulation (rTMS) cap delivering magnetic stimulation to part of the brain.
repetitive Transcranial Magnetic Stimulation -On: Cap worn on the scalp will deliver active Repetitive Transcranial Magnetic Stimulation to specific parts of the brain
|
Repetitive Transcranial Magnetic Stimulation -Off
n=15 participants at risk
Participants wear the repetitive transcranial magnetic stimulation (rTMS) cap that does NOT delivery any magnetic stimulation to the brain.
repetitive Transcranial Magnetic Stimulation -Off: Cap worn on the scalp will no delivery of the Repetitive Transcranial Magnetic Stimulation to any part of the, referred to as a sham or inactive study treatment.
|
|---|---|---|
|
General disorders
Fall
|
0.00%
0/16 • Adverse events were captured from time of first treatment to completion of the final visit at 3 months post treatment. Serious adverse events were captured from time of informed consent to completion of the final visit at 3 months post treatment.
All reported events were assessed by the Principal Investigator and resulted in no withdrawals due to study treatment
|
6.7%
1/15 • Number of events 1 • Adverse events were captured from time of first treatment to completion of the final visit at 3 months post treatment. Serious adverse events were captured from time of informed consent to completion of the final visit at 3 months post treatment.
All reported events were assessed by the Principal Investigator and resulted in no withdrawals due to study treatment
|
|
General disorders
Fatigue
|
0.00%
0/16 • Adverse events were captured from time of first treatment to completion of the final visit at 3 months post treatment. Serious adverse events were captured from time of informed consent to completion of the final visit at 3 months post treatment.
All reported events were assessed by the Principal Investigator and resulted in no withdrawals due to study treatment
|
6.7%
1/15 • Number of events 1 • Adverse events were captured from time of first treatment to completion of the final visit at 3 months post treatment. Serious adverse events were captured from time of informed consent to completion of the final visit at 3 months post treatment.
All reported events were assessed by the Principal Investigator and resulted in no withdrawals due to study treatment
|
|
General disorders
Muscle cramps
|
0.00%
0/16 • Adverse events were captured from time of first treatment to completion of the final visit at 3 months post treatment. Serious adverse events were captured from time of informed consent to completion of the final visit at 3 months post treatment.
All reported events were assessed by the Principal Investigator and resulted in no withdrawals due to study treatment
|
6.7%
1/15 • Number of events 1 • Adverse events were captured from time of first treatment to completion of the final visit at 3 months post treatment. Serious adverse events were captured from time of informed consent to completion of the final visit at 3 months post treatment.
All reported events were assessed by the Principal Investigator and resulted in no withdrawals due to study treatment
|
|
General disorders
Dizziness
|
6.2%
1/16 • Number of events 1 • Adverse events were captured from time of first treatment to completion of the final visit at 3 months post treatment. Serious adverse events were captured from time of informed consent to completion of the final visit at 3 months post treatment.
All reported events were assessed by the Principal Investigator and resulted in no withdrawals due to study treatment
|
6.7%
1/15 • Number of events 1 • Adverse events were captured from time of first treatment to completion of the final visit at 3 months post treatment. Serious adverse events were captured from time of informed consent to completion of the final visit at 3 months post treatment.
All reported events were assessed by the Principal Investigator and resulted in no withdrawals due to study treatment
|
|
Ear and labyrinth disorders
Transient tinnitus
|
6.2%
1/16 • Number of events 1 • Adverse events were captured from time of first treatment to completion of the final visit at 3 months post treatment. Serious adverse events were captured from time of informed consent to completion of the final visit at 3 months post treatment.
All reported events were assessed by the Principal Investigator and resulted in no withdrawals due to study treatment
|
0.00%
0/15 • Adverse events were captured from time of first treatment to completion of the final visit at 3 months post treatment. Serious adverse events were captured from time of informed consent to completion of the final visit at 3 months post treatment.
All reported events were assessed by the Principal Investigator and resulted in no withdrawals due to study treatment
|
Additional Information
David Chiu, M.D.
Houston Methodist Neurological Institute
Phone: 713-441-5801
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place