Accelerated Continue Theta-burst Stimulation (acTBS)Treatment for Obsessive Compulsive Disease

Accelerated cTBS and 1HZ-rTMS in the Treatment of Obsessive-compulsive Disorder With Individualized Stimulation Target

The therapeutic effects of high-dose accelerated continue theta-burst stimulation (acTBS) and 1-Hz repetitive transcranial magnetic stimulation (rTMS) on obsessive-compulsive disorder (OCD) and its neural mechanism were investigated by functional MRI.

Study Overview

• Status: Recruiting
• Conditions: Transcranial Magnetic Stimulation; Obsessive-Compulsive Disorder; Functional Magnetic Resonance Imaging; Accelerated Continue Theta-burst Stimulation
• Intervention / Treatment: Device: Transcranial magnetic stimulation with real coil; Device: Accelerated transcranial magnetic stimulation with real coil; Device: Transcranial magnetic stimulation with sham coil

Detailed Description

All patients underwent a medical evaluation that included physical examination and routine laboratory studies before and after transcranial magnetic stimulation (rTMS) treatment. Patients were randomly allocated to 1-Hz rTMS group，acTBS group and sham group. Patients ware allocated by random number. The decision to enroll a patient was always made prior to randomization. The 1-Hz rTMS group received one round of stimulation every day for 30 minutes with a total stimulation of 1800 pulses for 5 consecutive days. Patients in the acTBS group received 10 two-minute rounds of stimulation each day, spaced 50 minutes apart, with a total of 18,000 pulses for five days.

Before the TMS treatment, Y-BOCS, Obsessions Symptom Scale revised (OCI-R), Hamilton Depression Scale (HAMD-17) and Hamilton Anxiety Scale (HAMA-14) were obtained by a trained investigator to assess baseline severity 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。

After the last treatment, Yale-Brown Obsessive-Compulsive Scale (Y-BOCS), OCI-R, 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 5 days.The patients had also receiving a battery measure of neuropsychological tests and magnetic resonance imaging scan in multimodalities.

Participants were interviewed for two and four weeks after their last treatment to obtain a Y-BOCS score, and they were asked to focus their answers on the past week.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chunyan Zhu, professor; Phone Number: +86-0551-62923704; Email: ayswallow@126.com

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China, 230032
      • Recruiting
      • Anhui Medical University
      • Contact: Chunyan Zhu, professor; Phone Number: +86-0551-62923704; Email: ayswallow@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 41 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Clinical diagnosis of obsessive-compulsive disorder
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1-HZ repetition transcranial magnetic stimulation Stimulation; The repetition transcranial magnetic stimulation(rTMS) lasted 30 mins and delivered at 1 Hz with 1s duration, a total of 1800 pulses at 80% 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; The stimulation mode of TMS is 1-Hz repetitive Transcranial magnetic stimulation .
Experimental: accelerated continue theta-burst stimulation; Fifty intermittent TBS sessions (1800 pulses per session, 50 minute inter-session interval ) were delivered as ten daily sessions over five consecutive days at 80% resting motor threshold (RMT). The MRI data set should be collected before the first cTBS session and after the last cTBS session.	Device: Accelerated transcranial magnetic stimulation with real coil; The stimulation mode of TMS is accelerated continue theta-burst stimulation.
Sham Comparator: accelerated continue theta-burst stimulation (sham); Fifty intermittent TBS sessions (1800 pulses per session, 50 minute inter-session interval ) were delivered as ten daily sessions over five consecutive days at 80% resting motor threshold (RMT). The MRI data set should be collected before the first cTBS session and after the last rTMS session. No actual magnetic stimulation was applied on the head of the volunteers. MRI dataset should be acquired before the first cTBS session and after the last cTBS session.	Device: Transcranial magnetic stimulation with sham coil; The stimulation mode of TMS is accelerated continue theta-burst stimulation, but without active stimulation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	pre-treatment; 1 day post-treatment; Change from baseline score at 1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Obsessive Compulsive Inventory-Revised (OCI-R)	a simplified version of the OCI for self-assessment of Obsessive symptoms, Revised to include only 18 items from 42 items in the original Obsessive Compulsive Questionnaire. Divided into six obsessional subscales, respectively washing (5, 11, 17), obsessional thinking (6, 12, 18), storage (1, 7, 13), sorting (3, 9, 15), check (2, 8, 14), mixed (4, 10, 16), can be very good to distinguish the characteristics of different obsessional symptoms. Each item was assessed on a five-point scale of 0 to 4, with 0 being "not at all" and 5 being "extremely painful," and participants were asked to tick a number that best described the extent of their pain or distress on a scale of 0 to 72, with higher scores indicating more severe obsessive-compulsive symptoms. The questionnaire is simple and easy to understand. It can objectively evaluate individual obsessive-compulsive symptoms from six dimensions, with high reliability (0.82) and validity (0.81).	pre-treatment; 1 day post-treatment
Hamilton Depression Scale（HAMD）	Hamilton Depression Scale（HAMD）: An assessment of depressive mood status with 17 questions on a Scale of 0 to 4.	pre-treatment; 1 day post-treatment
Hamilton Anxiety Scale（HAMA）	Hamilton Anxiety Scale（HAMA）：a scale of 14 questions on a scale of 0 to 4 on a 5 scale.	pre-treatment; 1 day post-treatment
Stroop word test	To measure the conflict suppression ability of the subjects, consisting of three groups of cards, namely dot, word and color word. The subjects were asked to read the color as quickly and accurately as possible, and record the response time and accuracy. Behavioral indicators :(Stroop interference effects, SIE)= reaction time of color word - reaction time of word.	pre-treatment; 1 day post-treatment
Behavioral index TMT=TMT-B reaction time - TMT-A reaction time.	Evaluate the executive function of the subjects, including attention, memory, thinking flexibility, reasoning, conversion and other broad executive function components, including A and B. TMT is simple and involves less cognitive involvement. TMT-B involves response inhibition and attentional switching. The task required the subjects to complete the connection according to certain rules and record the reaction time. Behavioral index TMT=TMT-B reaction time - TMT-A reaction time.	pre-treatment; 1 day post-treatment

Collaborators and Investigators

• Sponsor: Anhui Medical University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Actual): January 6, 2022
• Study Completion (Anticipated): July 1, 2023

Study Registration Dates

• First Submitted: January 3, 2022
• First Submitted That Met QC Criteria: January 23, 2022
• First Posted (Actual): February 3, 2022

Study Record Updates

• Last Update Posted (Actual): April 14, 2023
• Last Update Submitted That Met QC Criteria: April 12, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Personality Disorders; Anxiety Disorders; Compulsive Personality Disorder; Obsessive-Compulsive Disorder
• Other Study ID Numbers: precise high-dose OCD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No