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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00106249
First Posted: March 22, 2005
Last Update Posted: January 27, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
New York State Psychiatric Institute
Results First Submitted: September 6, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Obsessive-Compulsive Disorder
Interventions: Device: Repetitive Transcranial Magnetic Stimulation (rTMS)
Device: Sham

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
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.


Participant Flow:   Overall Study
    Active rTMS   Sham rTMS
STARTED   14   13 
COMPLETED   11   11 
NOT COMPLETED   3   2 
Lost to Follow-up                3                2 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
A total of 22 patients with at least 1 follow up were included in the final analyses. Four subjects only had baseline measure. The reason for them to withdraw from the study was their inability to attend daily treatment sessions due to schedule conflict with their job and long commute to the TMS laboratory.

Reporting Groups
  Description
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.

Total Total of all reporting groups

Baseline Measures
   Active rTMS   Sham rTMS   Total 
Overall Participants Analyzed 
[Units: Participants]
 14   13   27 
Age 
[Units: Years]
Mean (Standard Deviation)
 40.1  (13.1)   37.1  (11.8)   38.6  (12.5) 
Gender 
[Units: Participants]
Count of Participants
     
Female      5  35.7%      5  38.5%      10  37.0% 
Male      9  64.3%      8  61.5%      17  63.0% 
Region of Enrollment 
[Units: Participants]
     
United States   14   13   27 


  Outcome Measures
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1.  Primary:   Clinical Improvement (Yale-Brown Obsessive Compulsive Scale/Y-BOCS)   [ Time Frame: Through study completion ]

2.  Secondary:   Motor Cortex Excitability (Motor Threshold)   [ Time Frame: Through study completion ]

3.  Secondary:   Motor Cortex Excitability (Short Intracortical Inhibition)   [ Time Frame: Through study completion ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Antonio Mantovani
Organization: CUNY
phone: 212-650-5417
e-mail: amantovani@med.cuny.edu


Publications:

Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00106249     History of Changes
Other Study ID Numbers: 5926R
First Submitted: March 21, 2005
First Posted: March 22, 2005
Results First Submitted: September 6, 2016
Results First Posted: January 27, 2017
Last Update Posted: January 27, 2017