Trial Outcomes & Findings for Transcranial Magnetic Stimulation (TMS) and Obsessive Compulsive Disorder (OCD) (NCT NCT00106249)

Results Overview

Response rate was defined as a decrease \>25% on the YBOCS-SR. Y-BOCS-Self Report (Baer et al. 1993) is very similar to the clinician-administered one, and has shown excellent internal consistency and test-retest reliability, performing somewhat better than the interview (Steketee et al., 1996); subjects are asked to focus on the main obsessions and main compulsions and to answer five questions: time spent, interference, distress, resistance, and control. Consistent with the interview format, subjects rate each item on a 0 (none) to 4 (extreme) scale.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

27 participants

Primary outcome timeframe

Through study completion

Results posted on

2017-01-27

Participant Flow

Participant milestones

Participant milestones
Measure	Active rTMS Active Repetitive Transcranial Magnetic Stimulation (rTMS) Repetitive Transcranial Magnetic Stimulation (rTMS): Stimulus train of 30 min duration, 1Hz frequency, and 110% of the motor threshold intensity given once a day, 5 days a week, for 4 weeks by Magstim SuperRapid Magnetic Stimulator.	Sham rTMS Placebo Repetitive Transcranial Magnetic Stimulation (rTMS) Sham: Sham rTMS will be administered using the Magstim Sham coil which contains a mu-metal shield that diverts the majority of the magnetic flux such that a minimal (less than 3%) magnetic field is delivered to the cortex in order to provoke a subjective sensation similar to that obtained with the real stimulation but without inducing significant cortical stimulation.
Overall Study STARTED	14	13
Overall Study COMPLETED	11	11
Overall Study NOT COMPLETED	3	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Active rTMS Active Repetitive Transcranial Magnetic Stimulation (rTMS) Repetitive Transcranial Magnetic Stimulation (rTMS): Stimulus train of 30 min duration, 1Hz frequency, and 110% of the motor threshold intensity given once a day, 5 days a week, for 4 weeks by Magstim SuperRapid Magnetic Stimulator.	Sham rTMS Placebo Repetitive Transcranial Magnetic Stimulation (rTMS) Sham: Sham rTMS will be administered using the Magstim Sham coil which contains a mu-metal shield that diverts the majority of the magnetic flux such that a minimal (less than 3%) magnetic field is delivered to the cortex in order to provoke a subjective sensation similar to that obtained with the real stimulation but without inducing significant cortical stimulation.
Overall Study Lost to Follow-up	3	2

Baseline Characteristics

Transcranial Magnetic Stimulation (TMS) and Obsessive Compulsive Disorder (OCD)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Active rTMS n=14 Participants Active Repetitive Transcranial Magnetic Stimulation (rTMS) Repetitive Transcranial Magnetic Stimulation (rTMS): Stimulus train of 30 min duration, 1Hz frequency, and 110% of the motor threshold intensity given once a day, 5 days a week, for 4 weeks by Magstim SuperRapid Magnetic Stimulator.	Sham rTMS n=13 Participants Placebo Repetitive Transcranial Magnetic Stimulation (rTMS) Sham: Sham rTMS will be administered using the Magstim Sham coil which contains a mu-metal shield that diverts the majority of the magnetic flux such that a minimal (less than 3%) magnetic field is delivered to the cortex in order to provoke a subjective sensation similar to that obtained with the real stimulation but without inducing significant cortical stimulation.	Total n=27 Participants Total of all reporting groups
Age, Continuous	40.1 years STANDARD_DEVIATION 13.1 • n=5 Participants	37.1 years STANDARD_DEVIATION 11.8 • n=7 Participants	38.6 years STANDARD_DEVIATION 12.5 • n=5 Participants
Gender Female	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Gender Male	9 Participants n=5 Participants	8 Participants n=7 Participants	17 Participants n=5 Participants
Region of Enrollment United States	14 participants n=5 Participants	13 participants n=7 Participants	27 participants n=5 Participants

PRIMARY outcome

Timeframe: Through study completion

Response rate was defined as a decrease \>25% on the YBOCS-SR. Y-BOCS-Self Report (Baer et al. 1993) is very similar to the clinician-administered one, and has shown excellent internal consistency and test-retest reliability, performing somewhat better than the interview (Steketee et al., 1996); subjects are asked to focus on the main obsessions and main compulsions and to answer five questions: time spent, interference, distress, resistance, and control. Consistent with the interview format, subjects rate each item on a 0 (none) to 4 (extreme) scale.

Outcome measures

Outcome measures
Measure	Active rTMS n=11 Participants Active Repetitive Transcranial Magnetic Stimulation (rTMS) Repetitive Transcranial Magnetic Stimulation (rTMS): Stimulus train of 30 min duration, 1Hz frequency, and 110% of the motor threshold intensity given once a day, 5 days a week, for 4 weeks by Magstim SuperRapid Magnetic Stimulator.	Sham rTMS n=11 Participants Placebo Repetitive Transcranial Magnetic Stimulation (rTMS) Sham: Sham rTMS will be administered using the Magstim Sham coil which contains a mu-metal shield that diverts the majority of the magnetic flux such that a minimal (less than 3%) magnetic field is delivered to the cortex in order to provoke a subjective sensation similar to that obtained with the real stimulation but without inducing significant cortical stimulation.
Clinical Improvement (Yale-Brown Obsessive Compulsive Scale/Y-BOCS)	36 percentage of participants	9 percentage of participants

SECONDARY outcome

Timeframe: Through study completion

Population: repeated measure ANOVA, time X group interaction, right hemisphere MT

In 22 OCD patients, who completed the RCT, we applied the new customized software for acquisition and analysis of neurophysiology data that was developed to allow for automatic control of the TMS devices during motor cortex excitability measures. Specifically, the software delivers TMS pulses and automatically determines motor threshold (MT); a descending staircase method is utilized, starting at the intensity at which the optimal site selection for the MT is determined. After each stimulus in the MT experiments, the software would prompt the user to confirm the automated MEP-detection.

Outcome measures

Outcome measures
Measure	Active rTMS n=11 Participants Active Repetitive Transcranial Magnetic Stimulation (rTMS) Repetitive Transcranial Magnetic Stimulation (rTMS): Stimulus train of 30 min duration, 1Hz frequency, and 110% of the motor threshold intensity given once a day, 5 days a week, for 4 weeks by Magstim SuperRapid Magnetic Stimulator.	Sham rTMS n=11 Participants Placebo Repetitive Transcranial Magnetic Stimulation (rTMS) Sham: Sham rTMS will be administered using the Magstim Sham coil which contains a mu-metal shield that diverts the majority of the magnetic flux such that a minimal (less than 3%) magnetic field is delivered to the cortex in order to provoke a subjective sensation similar to that obtained with the real stimulation but without inducing significant cortical stimulation.
Motor Cortex Excitability (Motor Threshold)	13 % MT change on right hemisphere Interval 0.0 to 100.0	0 % MT change on right hemisphere Interval 0.0 to 100.0

SECONDARY outcome

Timeframe: Through study completion

Population: Independent sample t-test, right hemisphere SICI

In 22 OCD patients enrolled in the RCT, we applied the new customized software for acquisition and analysis of neurophysiology data that was developed to allow for automatic control of the TMS devices during motor cortex excitability measures. For the paired-pulse (PP) measurements of short intracortical inhibition (SICI) the interstimulus interval (ISI) was set to 8-12 seconds on a continuous uniform distribution. The FPGA board samples the EMG data, controls the timing of the TMS stimuli, and also controls the intensity of the devices.

Outcome measures

Outcome measures
Measure	Active rTMS n=11 Participants Active Repetitive Transcranial Magnetic Stimulation (rTMS) Repetitive Transcranial Magnetic Stimulation (rTMS): Stimulus train of 30 min duration, 1Hz frequency, and 110% of the motor threshold intensity given once a day, 5 days a week, for 4 weeks by Magstim SuperRapid Magnetic Stimulator.	Sham rTMS n=11 Participants Placebo Repetitive Transcranial Magnetic Stimulation (rTMS) Sham: Sham rTMS will be administered using the Magstim Sham coil which contains a mu-metal shield that diverts the majority of the magnetic flux such that a minimal (less than 3%) magnetic field is delivered to the cortex in order to provoke a subjective sensation similar to that obtained with the real stimulation but without inducing significant cortical stimulation.
Motor Cortex Excitability (Short Intracortical Inhibition)	2.5 % change in conditioned/control MEP Interval 0.0 to 3.0	1 % change in conditioned/control MEP Interval 0.0 to 3.0

Adverse Events

Active rTMS

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sham rTMS

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. Antonio Mantovani

CUNY

Phone: 212-650-5417

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place