Repetitive Transcranial Magnetic Stimulation (rTMS) Treatment for Obsessive Compulsive Disease

NCT03393078 | Completed DMC

• 1 other identifier: AnhuiMU
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

To investigate the treatment effect of repetitive transcranial magnetic stimulation on Obsessive-compulsive disorder, and the underlying neural mechanism by functional MRI.

Conditions

Obsessive-Compulsive Disorder; Transcranial Magnetic Stimulation; Functional Magnetic Resonance Imaging; Event-Related Potentials

Outcome Measures

Primary Outcomes (1)

• Symptom improvement assessed by the Yale-Brown Obsessive Compulsive Scale

  The Yale-Brown Obsessive Compulsive Scale is a test to rate the severity of obsessive-compulsive disorder symptoms, which measures obsessions separately from compulsions. The scale includes 10 items, the first 5 items are evaluated obsessions, the rest are assessments compulsions. Each item 0-4 points, a total of 40 points. The lower the score, the better the outcome.

  up to 1 months

Secondary Outcomes (5)

• Stop-Signal Task

  pre-treatment; 1 day post-treatment

• Task Switch

  pre-treatment; 1 day post-treatment

• Wisconsin CardSorting Test

  pre-treatment; 1 day post-treatment

• Hanoi Tower

  pre-treatment; 1 day post-treatment

• Symptom improvement assessed by the Padua Inventory-Washington State University Revision

  up to 1 months

Study Arms (2)

Real Stimulation

ACTIVE COMPARATOR

The repetition transcranial magnetic stimulation(rTMS) lasted 30 mins and delivered at 1 Hz with 1s duration, a total of 1800 pulses at 110% of the rest motor threshold (RMT) . MRI dataset should be acquired before the first rTMS session and after the last rTMS session.

Device: transcranial magnetic stimulation with real coil

Sham Stimulation

SHAM COMPARATOR

The procedure of this protocol was performed by a placebo coil, lasted 30 mins and delivered at 1 Hz with 1s duration, a total of 1800 pulses at 110% of the rest motor threshold (RMT). No actual magnetic stimulation was applied on the head of the volunteers. MRI dataset should be acquired before the first rTMS session and after the last rTMS session.

Device: transcranial magnetic stimulation with sham coil

Interventions

transcranial magnetic stimulation with real coil DEVICE

TMS with real coil is a noninvasive technique to activate and modify the activity of the neurons

Real Stimulation

transcranial magnetic stimulation with sham coil DEVICE

TMS with sham coil is a placebo

Sham Stimulation

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients met diagnostic criteria for obsessive-compulsive disorder using The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)，confirmed by two clinical psychiatrist.
• Y-BOCS total severity scores ≥16（Simple forced obsessions or compulsions ≥ 10），HAMA-14 scores \< 14，HAMD-17 scores \< 17； Raven's Standard Progressive Matrices（SPM） up to normal levels.
• After more than one anti-OCD drugs treatment for 8-10 weeks, no significant improvement in symptoms.
• Voluntarily participated and cooperated with the experiment.

You may not qualify if:

• \- History of significant head trauma or neurological disorders. Alcohol or drug abuse. Organic brain defects on T1 or T2 images. History of seizures or unexplained loss of consciousness. Family history of medication refractory epilepsy. recent aggression or other forms of behavioral dyscontrol.

Sponsors & Collaborators

• Anhui Medical University: lead

Study Sites (1)

Anhui Medical University

Hefei, Anhui, 230032, China

Location

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: A/Prof.

Study Record Dates

• First Submitted: December 28, 2017
• First Posted: January 8, 2018
• Study Start: August 1, 2017
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: January 4, 2022

Record last verified: 2021-12

Locations

CN (1)