Trial Outcomes & Findings for Rapid Non-Invasive Brain Stimulation for OCD (oTMS) (NCT NCT03404609)
NCT ID: NCT03404609
Last Updated: 2021-05-14
Results Overview
Patients given YBOCS (Yale Brown Obsessive-Compulsive Scale), a gold standard measure of obsessions and compulsions. For the YBOCS the minimum units are 0 and Maximum units on the total scale are 40. The higher the number on the YBOCS, the more severe the symptoms. Response was defined as at least a 35% reduction on the YBOCS.
COMPLETED
NA
7 participants
Baseline and up to two weeks
2021-05-14
Participant Flow
Participant milestones
| Measure |
rTMS
Participants in the rTMS group will receive MagPro X100 by MagVenture (Active) cortical stimulation condition.
MagPro X100 by MagVenture: Participants in the rTMS group will receive MagPro X100 by MagVenture cortical stimulation condition.
|
|---|---|
|
Overall Study
STARTED
|
7
|
|
Overall Study
COMPLETED
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Rapid Non-Invasive Brain Stimulation for OCD (oTMS)
Baseline characteristics by cohort
| Measure |
rTMS
n=7 Participants
Participants in the rTMS group will receive MagPro X100 by MagVenture (Active) cortical stimulation condition.
MagPro X100 by MagVenture: Participants in the rTMS group will receive MagPro X100 by MagVenture cortical stimulation condition.
|
|---|---|
|
Age, Continuous
|
40 years
STANDARD_DEVIATION 15 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and up to two weeksPatients given YBOCS (Yale Brown Obsessive-Compulsive Scale), a gold standard measure of obsessions and compulsions. For the YBOCS the minimum units are 0 and Maximum units on the total scale are 40. The higher the number on the YBOCS, the more severe the symptoms. Response was defined as at least a 35% reduction on the YBOCS.
Outcome measures
| Measure |
rTMS
n=7 Participants
Participants in the rTMS group will receive MagPro X100 by MagVenture (Active) cortical stimulation condition.
MagPro X100 by MagVenture: Participants in the rTMS group will receive MagPro X100 by MagVenture cortical stimulation condition.
|
|---|---|
|
Number of Patients Who Met and Exceeded Response Criteria of Yale-Brown Obsessive-Compulsive Scale.
|
4 Participants
|
Adverse Events
rTMS
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
rTMS
n=7 participants at risk
Participants in the rTMS group will receive MagPro X100 by MagVenture (Active) cortical stimulation condition.
MagPro X100 by MagVenture: Participants in the rTMS group will receive MagPro X100 by MagVenture cortical stimulation condition.
|
|---|---|
|
Nervous system disorders
Fatigue
|
42.9%
3/7 • Number of events 3 • Baseline and through study completion (e.g., up to approximately 4 weeks)
|
|
Nervous system disorders
headache
|
57.1%
4/7 • Number of events 4 • Baseline and through study completion (e.g., up to approximately 4 weeks)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place