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

Obsessive-Compulsive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05221632
• Other study ID #: precise high-dose OCD
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: July 1, 2023

Study information

• Verified date: April 2023
• Source: Anhui Medical University
• Contact: Chunyan Zhu, professor
• Phone: +86-0551-62923704
• Email: ayswallow[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 1, 2023
• Est. primary completion date: January 6, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Functional Magnetic Resonance Imaging
• Obsessive-Compulsive Disorder
• Transcranial Magnetic Stimulation

Intervention

Device:
• Accelerated transcranial magnetic stimulation with real coil
The stimulation mode of TMS is accelerated continue theta-burst stimulation.
• Transcranial magnetic stimulation with real coil
The stimulation mode of TMS is 1-Hz repetitive Transcranial magnetic stimulation .
• Transcranial magnetic stimulation with sham coil
The stimulation mode of TMS is accelerated continue theta-burst stimulation, but without active stimulation.

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.	pre-treatment; 1 day post-treatment; Change from baseline score at 1 month
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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