Trial Outcomes & Findings for The Use of Magnetic Brain Stimulation to Treat Obsessive Compulsive Disorder, a Pilot Study (NCT NCT02541812)

NCT ID: NCT02541812

Last Updated: 2020-09-17

Results Overview

Yale-Brown Obsessive Compulsive Scale. Minimum value = 0. Maximum value = 40. Higher scores indicate greater severity of obsessive and compulsive symptoms.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

20 participants

Primary outcome timeframe

Recordings: baseline; after two weeks of rTMS

Results posted on

2020-09-17

Participant Flow

Participant milestones

Participant milestones
Measure
Patients
Ten sessions of 1Hz repetitive Transcranial Magnetic Stimulation of the dorsal anterior cingulate cortex in patients with obsessive compulsive disorder Transcranial Magnetic Stimulation: A non-invasive method for brain stimulation
Healthy Control Subjects
One session of 1Hz repetitive Transcranial Magnetic Stimulation of the dorsal anterior cingulate cortex in healthy control individuals Transcranial Magnetic Stimulation: A non-invasive method for brain stimulation
Overall Study
STARTED
10
10
Overall Study
COMPLETED
10
10
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Patients
n=10 Participants
Ten sessions of 1Hz repetitive Transcranial Magnetic Stimulation of the dorsal anterior cingulate cortex in patients with obsessive compulsive disorder Transcranial Magnetic Stimulation: A non-invasive method for brain stimulation
Healthy Control Subjects
n=10 Participants
One session of 1Hz repetitive Transcranial Magnetic Stimulation of the dorsal anterior cingulate cortex in healthy control individuals Transcranial Magnetic Stimulation: A non-invasive method for brain stimulation
Total
n=20 Participants
Total of all reporting groups
Age, Continuous
28.7 years
STANDARD_DEVIATION 12.1 • n=10 Participants
29.5 years
STANDARD_DEVIATION 12.1 • n=10 Participants
29.2 years
STANDARD_DEVIATION 12.1 • n=20 Participants
Sex: Female, Male
Female
8 Participants
n=10 Participants
4 Participants
n=10 Participants
12 Participants
n=20 Participants
Sex: Female, Male
Male
2 Participants
n=10 Participants
6 Participants
n=10 Participants
8 Participants
n=20 Participants
Race and Ethnicity Not Collected
0 Participants
Race and Ethnicity were not collected from any participant.
Region of Enrollment
Canada
10 participants
n=10 Participants
10 participants
n=10 Participants
20 participants
n=20 Participants

PRIMARY outcome

Timeframe: Recordings: baseline; after two weeks of rTMS

Yale-Brown Obsessive Compulsive Scale. Minimum value = 0. Maximum value = 40. Higher scores indicate greater severity of obsessive and compulsive symptoms.

Outcome measures

Outcome measures
Measure
Patients
n=10 Participants
Ten sessions of 1Hz repetitive Transcranial Magnetic Stimulation of the dorsal anterior cingulate cortex in patients with obsessive compulsive disorder Transcranial Magnetic Stimulation: A non-invasive method for brain stimulation
Healthy Control Subjects
One session of 1Hz repetitive Transcranial Magnetic Stimulation of the dorsal anterior cingulate cortex in healthy control individuals Transcranial Magnetic Stimulation: A non-invasive method for brain stimulation
Change in Obsessive and Compulsive Symptom Severity (Yale-Brown Obsessive Compulsive Scale)
-39.4 Percent change
Standard Deviation 15.4

SECONDARY outcome

Timeframe: Recordings: baseline; after one session of rTMS

Post-error slowing (PES) is the difference in response time on trials following an error to trials following a correct response. Higher numbers indicate more post-error slowing (i.e. longer response times following an error trial compared to following a correct trial). The outcome measure is the change in PES from baseline to following one session of rTMS.

Outcome measures

Outcome measures
Measure
Patients
n=10 Participants
Ten sessions of 1Hz repetitive Transcranial Magnetic Stimulation of the dorsal anterior cingulate cortex in patients with obsessive compulsive disorder Transcranial Magnetic Stimulation: A non-invasive method for brain stimulation
Healthy Control Subjects
n=10 Participants
One session of 1Hz repetitive Transcranial Magnetic Stimulation of the dorsal anterior cingulate cortex in healthy control individuals Transcranial Magnetic Stimulation: A non-invasive method for brain stimulation
Change in Post-error Slowing
1.4 ms
Standard Deviation 5.8
-3.0 ms
Standard Deviation 4.8

Adverse Events

Patients

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Healthy Control Subjects

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Mandana Modirrousta

University of Manitoba

Phone: 2042372303

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place