NCT02528331

Brief Summary

The purpose of this study is to evaluate the effectiveness of repetitive TMS (rTMS) delivered simultaneously with elements of cognitive behavioral therapy/exposure-response prevention (CBT/ERP) in adult subjects (greater or equal to 18 years old) with obsessive-compulsive disorder (OCD). This is an open label study that involves standard of care for OCD (CBT) and an investigational treatment modality (TMS). The investigators will compare the Yale-Brown Obsessive Compulsive Scale (YBOCS) scores before and after treatment to quantify clinical improvement. The side effects from TMS include, but are not limited to, headache, seizure, and general pain. CBT has minimal side effects other than mental discomfort during the exposure sessions. For safety concerns, pregnant women and subjects with seizure-related history will be excluded as well as other indicated conditions in the details protocol.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 17, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 19, 2015

Completed
7 months until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
6 months until next milestone

Results Posted

Study results publicly available

February 9, 2017

Completed
Last Updated

February 9, 2017

Status Verified

November 1, 2016

Enrollment Period

4 months

First QC Date

August 17, 2015

Results QC Date

November 29, 2016

Last Update Submit

December 19, 2016

Conditions

Obsessive Compulsive Disorder (OCD)

Keywords

Transcranial magnetic stimulation (TMS)Cognitive behavioral therapy (CBT)

Outcome Measures

Primary Outcomes (1)

  • Remission Rate, as Measured by Y-BOCS

    Remission is defined as end-point Yale-Brown Obsessive Compulsive Scale (Y-BOCS) score less than the value of 16.

    6 weeks

Secondary Outcomes (3)

  • Complete Response, as Measured by Y-BOCS

    6 weeks

  • Partial Response Rate, as Measured by Y-BOCS

    6 weeks

  • Percentage of Adverse Events

    6 weeks

Study Arms (1)

rTMS and Cognitive Behavior Therapy

EXPERIMENTAL
Device: Transcranial magnetic stimulationBehavioral: Cognitive behavioral therapy

Interventions

Transcranial magnetic stimulationDEVICE
rTMS and Cognitive Behavior Therapy
Cognitive behavioral therapyBEHAVIORAL
rTMS and Cognitive Behavior Therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All subjects will be 18 - 65 years of age.
  • Obsessive-compulsive disorder:
  • Subjects will meet the DSM-IV primary diagnosis of obsessive-compulsive
  • Y-BOCS total score \> 16
  • Subjects are willing and able to adhere to the intensive treatment schedule and all required study visits.

You may not qualify if:

  • Subjects are unable or unwilling to give informed consent.
  • Subjects with a clinically defined neurological disorder that caused significant safety concern to receive TMS treatment, including, but not limited to:
  • Any condition likely to be associated with increased intracranial pressure.
  • Space occupying brain lesion.
  • Any history of seizure EXCEPT those therapeutically induced by ECT (childhood febrile seizures are acceptable and these subjects may be included in the study).
  • History of stroke.
  • Transient ischemic attack within two years.
  • Cerebral aneurysm.
  • Dementia.
  • Mini Mental Status Exam (MMSE-2) score of \<24.
  • Parkinson's disease.
  • Huntington's disease.
  • Multiple sclerosis.
  • Increased risk of seizure for any reason, including prior diagnosis of increased intracranial pressure (such as after large infarctions or trauma), or currently taking medication that lowers the seizure threshold. Medications that lower the seizure threshold are included in the Prohibited Concomitant Medication (Section 5.8).
  • Subjects with any of the following treatment histories:
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

Transcranial Magnetic StimulationCognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeuticsBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Limitations and Caveats

This trial was terminated early leading to small numbers of subjects analyzed.

Results Point of Contact

Title
Richard Weiner, MD, PhD
Organization
Duke University
weine002@duke.edu
919-681-8742

Study Officials

  • Richard Weiner, MD

    Duke University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 17, 2015

First Posted

August 19, 2015

Study Start

March 1, 2016

Primary Completion

July 1, 2016

Study Completion

August 1, 2016

Last Updated

February 9, 2017

Results First Posted

February 9, 2017

Record last verified: 2016-11

Locations

US(1)