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N/A N=26 Randomized Triple-blind Treatment

Transcranial Magnetic Stimulation (TMS) in Obsessive Compulsive Disorder (OCD): Mechanisms and Biomarkers

Obsessive Compulsive Disorder

Enrolled (actual)
26
Serious AEs
0.0%
Results posted
Jun 2023
Primary outcome: Primary: Obsessive Compulsive Symptoms as Measured by Yale-Brown Obsessive Compulsive Scale (Y-BOCS) — 23.9; 23.1; 23.23; 20.6 score on a scale

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Transcranial Magnetic Stimulation (Device)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Massachusetts General Hospital
Primary completion
Oct 2021

Outcome Measures

OutcomeResultp-value
PRIMARY
Obsessive Compulsive Symptoms as Measured by Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
23.9; 23.1; 23.23; 20.6; 23.5; 17.0
SECONDARY
Obsessive Compulsive Beliefs as Measured by Obsessive-Compulsive Beliefs Questionnaire (OBQ)
186.53; 178.91; 190.60; 180.30; 220.00; 147.00
SECONDARY
Total Number of Obsessive Symptoms is Reduced as Measured by Obsessive-Compulsive Inventory Questionnaire (OCI)-Revised
26.27; 31.20; 31.00; 24.70; 30.50; 15.50

Summary

The purpose of this study is to test the efficacy of 1-Hz repetitive transcranial magnetic stimulation (TMS) over the pre-supplementary motor area as a treatment for obsessive compulsive disorder. Additionally, this study aims to identify the mechanisms of action of TMS and potential biomarkers and predictors of treatment response.

Eligibility Criteria

Inclusion Criteria

  • 18-65 years of age.
  • Proficient in English.
  • A diagnosis of primary OCD (as determined by SCID).
  • Yale-Brown Obsessive Compulsive Scale total score ≥ 16.
  • Normal (or corrected) vision.
  • Stable medication regimen or medication free for ≥ 12 weeks prior to study; benzodiazepine free ≥ 2 weeks.
  • Right-handed (Edinburgh Handedness Inventory - Short Form total score ≥ 61)
  • Able to give informed consent.

Exclusion Criteria

  • Current or history of neurologic or psychiatric disease (e.g., mental retardation, dementia, brain damage, or other cognitive impairment) that would interfere with ability to engage in TMS
  • Psychopathology not appropriate for the treatment (e.g., manic episode or psychosis)
  • Substance abuse or dependence that is current or within the last six months or use of an illicit drug that is not prescribed, as indicated by a urine drug screen and/or clinical inference.
  • Use of benzodiazepines or anticonvulsants within 2 weeks prior to study (to be ruled out by a urine drug screen).
  • Use of Tricyclic Antidepressants (e.g. Clomipramine).
  • Use of other psychotropic medications (e.g., SSRIs) will be allowed provided the dose has been stable for > 12 weeks.
  • Documented resistance to 4 or more valid pharmacological trials of 2 or more different medication classes (e.g. SSRIs and TCAs).
  • Previous exposure to TMS.
  • Major/chronic medical conditions.
  • History of head injury resulting in prolonged loss of consciousness and/or neurological sequelae.
  • Prior neurosurgical procedure.
  • Metal in the body, metal injury to the eyes.
  • History of seizures.
  • Implanted pacemaker, medication pump, vagal stimulator, deep brain stimulator, TENS unit, or ventriculo-peritoneal shunt
  • Pregnancy; breastfeeding or nursing; for women of childbearing a pregnancy test (to be ruled out by urine β-HCG) will be conducted prior to study.
  • Currently in Cognitive Behavioral Therapy (CBT).
  • Diagnosis of primary sleep disorder such as primary insomnia, narcolepsy, sleep apnea, shift work sleep disorder and others. Sleep disorders such as insomnia or hypersomnia that are secondary to depression or OCD are permitted.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02355002). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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