Study of Magnetic Brain Stimulation in Treatment of Obses... | NCT02018185

Studies
Study of Magnetic Brain Stimulation in Treatment of Obsessive Compulsive Disorder

NCT02018185

Sponsor

University of Manitoba

Status

Suspended

Last Update Posted

Mar 23, 2021Actual

Enrollment

30Estimated

Phase

Not Applicable

Conditions

Obsessive Compulsive Disorder

Interventions

Transcranial Magnetic Stimulation
Sham Transcranial Magnetic Stimulation

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2021

Overall Recruitment Status or Expanded Access Status

Suspended

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Recruitment has been suspended in order to perform interim data analysis.

Expanded Access Info

Start Date

Jan 2014Actual

Primary Completion Date

Dec 2018Actual

Completion Date

Aug 2021Estimated

First Submitted Date

Dec 10, 2013

First Submission Date that Met QC Criteria

Dec 16, 2013

First Posted Date

Dec 23, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 22, 2021

Last Update Posted Date

Mar 23, 2021Actual

Name	Class
Manitoba Medical Service Foundation	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

In a preliminary pilot study, the investigators tested the efficacy of rTMS over the medial prefrontal cortex in symptom profiles of obsessive compulsive disorder (OCD) patients. This study revealed considerable benefit in using rTMS for the treatment of OCD.

In the current proposal, in a randomized clinical trial, the investigators aim to further evaluate the efficacy of rTMS in OCD in a larger sample size and for a longer period. Studies into the efficacy of rTMS in other psychiatric disorders such as depression have consistently shown that extension of the treatment to four weeks significantly increased the effect size. In the pilot study, the investigators applied rTMS for only two weeks. Although all patients consistently showed improvement in their symptoms, none of them showed complete remission of their OCD. Here, the investigators hypothesize that longer duration of rTMS treatment will have greater benefit in OCD symptom reduction.

Detailed Description

The purpose of study is to examine the efficacy of rTMS over the medial prefrontal cortex in the treatment of OCD.

rTMS will be provided to OCD patients in a randomized double blind controlled setting, and the investigators hypothesize that in this setting the treatment group would still show significant improvement in OCD symptoms as compared to the sham group.

rTMS will be applied for four weeks on OCD patients and the investigators will assess improvement after four weeks of rTMS. The investigators hypothesize that patients will show significantly greater improvement after four weeks of rTMS vs. two weeks of rTMS.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Transcranial Magnetic Stimulation	Active Comparator	Transcranial Magnetic Stimulation	Device: Transcranial Magnetic Stimulation
Sham rTMS	Sham Comparator	Sham Transcranial Magnetic Stimulation	Device: Sham Transcranial Magnetic Stimulation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Transcranial Magnetic Stimulation	Device	A non-invasive method for brain stimulation	Transcranial Magnetic Stimulation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in obsessive and compulsive symptom severity (Yale-Brown Obsessive Compulsive Scale)		Recordings: baseline; after two weeks of rTMS; after four weeks of rTMS; monthly for three months following the last session of rTMS

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosed obsessive compulsive disorder
Not currently receiving cognitive behavioural therapy
Not currently on any medication or only taking one selective serotonin reuptake inhibitor (SSRI)

Exclusion Criteria:

History of psychotic episodes
History of neurological illness
Previous head injury
Active alcohol or substance abuse
History of seizure disorders
Currently pregnant

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
St. Boniface Hospital		Winnipeg	Manitoba	R3P2B4	Canada

Type	Date	Date Unknown
Release	Oct 1, 2021
Reset	Oct 29, 2021

Submission Tracking

Estimated Results First Submitted Date

Oct 1, 2021

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Oct 1, 2021			Oct 29, 2021

Condition Browse Module

MeSH Terms

ID	Term
D009771	Obsessive-Compulsive Disorder

Ancestor Terms

ID	Term
D001008	Anxiety Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D050781	Transcranial Magnetic Stimulation

Ancestor Terms

ID	Term
D055909	Magnetic Field Therapy
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided