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

Obsessive-Compulsive Disorder Clinical Trial

Official title:

Study of Brain Network Mechanism for Individualized Accurate Target Positioning rTMS Treatment on Obsessive Compulsive Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03393078
• Other study ID #: AnhuiMU
• Status: Completed
• Phase: N/A
• Start date: August 1, 2017
• Est. completion date: December 1, 2020

Study information

• Verified date: December 2021
• Source: Anhui Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

All patients underwent a medical evaluation that included physical examination and routine laboratory studies before and after repetitive transcranial magnetic stimulation (rTMS) treatment. Patients were randomly allocated to rTMS group and the sham group. There are about 30 patients in each group. For the first 30 patients, allocation was by coin toss. For the subsequent 30 patients, allocation was according to computer generated random numbers. The decision to enroll a patient was always made prior to randomization. Patients were studied using a double-blind design. Study participants, clinical raters, and all personnel responsible for the clinical care of the patient remained masked to allocated condition and allocation parameters. Only rTMS administrators had access to the randomization list; they had minimal contact with the patients, and no role in assessing the Yale-Brown Obsessive Compulsive Scale(Y-BOCS). Each patient would be treated for continuous 15 days by rTMS.

Before the rTMS treatment, Y-BOCS, Padua Inventory-Washington State University Revision(PI-WSUR), Hamilton Depression Scale(HAMD-17) and Hamilton Anxiety Scale (HAMA-14) were obtained by a trained investigator to assess baseline severity of and other symptoms. The patients had receiving a battery measure of neuropsychological tests (standardized tests to investigate their cognitive problems, anxiety and depressive symptoms in daily life), magnetic resonance imaging scan in multimodalities, electroencephalography (EEG), event-related potentials during stop signal test and task switch paradigm record.

After the last treatment, Y-BOCS, PI-WSUR, HAMD-17 and HAMA-14 were obtained, as well as the Global Index of Safety to assess adverse events of the treatment. Patients were instructed to focus their answers on the past 15 days. The patients had also receiving a battery measure of neuropsychological tests, magnetic resonance imaging scan in multimodalities, and EEG record.

A month after the last treatment, participants were interviewed to obtain the Y-BOCS, PI-WSUR, HAMD-17 and HAMA-14. They were instructed to focus their answers on the past week. Additionally, they were also asked to assess the battery of neuropsychological tests, and have magnetic resonance imaging scan in multimodalities, and EEG record. Afterwards, they were unblinded by the study coordinator.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: December 1, 2020
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

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

Intervention

Device:
• transcranial magnetic stimulation with real coil
TMS with real coil is a noninvasive technique to activate and modify the activity of the neurons
• transcranial magnetic stimulation with sham coil
TMS with sham coil is a placebo

Locations

Country	Name	City	State
China	Anhui Medical University	Hefei	Anhui

Sponsors (1)

Lead Sponsor	Collaborator
Anhui Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Stop-Signal Task	Stop-Signal Task is a typical paradigm for measuring response inhibition and contains three indicators: Stop-signal reaction time (SSRT), the lower the SSRT value, the better the inhibition of reaction; Go task reaction time (GORT), GoRT is usually used in combination with SSRT to reveal the impaired of response inhibition; Stop-signal delays (SSD), SSD value increases, more difficult to inhibit successfully.	pre-treatment; 1 day post-treatment
Secondary	Task Switch	Task Switch is a paradigm for measuring cognitive flexibility, which involves the ability to unconsciously shift attention between one task and another and contains two indicators: task repeat and task switch.	pre-treatment; 1 day post-treatment
Secondary	Wisconsin CardSorting Test	The Wisconsin Card Sorting Test is a cognitive neuropsychological test, used to determine the abilities of human abstraction, concept formation, working memory and cognitive flexibility. Test measures a total of five indicators: Correct Response, Total Errors, Perseverative Responses, Perseverative Errors and Trials to complete 1st cat.	pre-treatment; 1 day post-treatment
Secondary	Hanoi Tower	Hanoi Tower is a test of planning and problem solving, that contains four indicators: total movement, Latency, 1st move reaction time and total reaction time.	pre-treatment; 1 day post-treatment
Secondary	Symptom improvement assessed by the Padua Inventory-Washington State University Revision	The Padua Inventory-Washington State University Revision is a self-rating scale for the severity of symptoms,that contains 5 subscales, 35 items. Each item 0-4 points, a total of 140 points. The lower the score, the better the outcome.	up to 1 months