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

Primary Purpose

Obsessive-Compulsive Disorder, Accelerated Continue Theta-burst Stimulation, Transcranial Magnetic Stimulation

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Accelerated transcranial magnetic stimulation with real coil
Transcranial magnetic stimulation with real coil
Transcranial magnetic stimulation with sham coil
Sponsored by
Anhui Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obsessive-Compulsive Disorder

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Anhui Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Sham Comparator

Arm Label

accelerated continue theta-burst stimulation

1-HZ repetition transcranial magnetic stimulation Stimulation

accelerated continue theta-burst stimulation (sham)

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
Hamilton Depression Scale(HAMD)
Hamilton Depression Scale(HAMD): An assessment of depressive mood status with 17 questions on a Scale of 0 to 4.
Hamilton Anxiety Scale(HAMA)
Hamilton Anxiety Scale(HAMA):a scale of 14 questions on a scale of 0 to 4 on a 5 scale.
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.
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.

Full Information

First Posted
January 3, 2022
Last Updated
April 12, 2023
Sponsor
Anhui Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05221632
Brief Title
Accelerated Continue Theta-burst Stimulation (acTBS)Treatment for Obsessive Compulsive Disease
Official Title
Accelerated cTBS and 1HZ-rTMS in the Treatment of Obsessive-compulsive Disorder With Individualized Stimulation Target
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
January 6, 2022 (Actual)
Study Completion Date
July 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Anhui Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obsessive-Compulsive Disorder, Accelerated Continue Theta-burst Stimulation, Transcranial Magnetic Stimulation, Functional Magnetic Resonance Imaging

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
accelerated continue theta-burst stimulation
Arm Type
Experimental
Arm Description
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.
Arm Title
1-HZ repetition transcranial magnetic stimulation Stimulation
Arm Type
Active Comparator
Arm Description
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.
Arm Title
accelerated continue theta-burst stimulation (sham)
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Accelerated transcranial magnetic stimulation with real coil
Intervention Description
The stimulation mode of TMS is accelerated continue theta-burst stimulation.
Intervention Type
Device
Intervention Name(s)
Transcranial magnetic stimulation with real coil
Intervention Description
The stimulation mode of TMS is 1-Hz repetitive Transcranial magnetic stimulation .
Intervention Type
Device
Intervention Name(s)
Transcranial magnetic stimulation with sham coil
Intervention Description
The stimulation mode of TMS is accelerated continue theta-burst stimulation, but without active stimulation.
Primary Outcome Measure Information:
Title
Symptom improvement assessed by the Yale-Brown Obsessive Compulsive Scale
Description
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.
Time Frame
pre-treatment; 1 day post-treatment; Change from baseline score at 1 month
Secondary Outcome Measure Information:
Title
Obsessive Compulsive Inventory-Revised (OCI-R)
Description
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).
Time Frame
pre-treatment; 1 day post-treatment
Title
Hamilton Depression Scale(HAMD)
Description
Hamilton Depression Scale(HAMD): An assessment of depressive mood status with 17 questions on a Scale of 0 to 4.
Time Frame
pre-treatment; 1 day post-treatment
Title
Hamilton Anxiety Scale(HAMA)
Description
Hamilton Anxiety Scale(HAMA):a scale of 14 questions on a scale of 0 to 4 on a 5 scale.
Time Frame
pre-treatment; 1 day post-treatment
Title
Stroop word test
Description
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.
Time Frame
pre-treatment; 1 day post-treatment
Title
Behavioral index TMT=TMT-B reaction time - TMT-A reaction time.
Description
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.
Time Frame
pre-treatment; 1 day post-treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chunyan Zhu, professor
Phone
+86-0551-62923704
Email
ayswallow@126.com
Facility Information:
Facility Name
Anhui Medical University
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chunyan Zhu, professor
Phone
+86-0551-62923704
Email
ayswallow@126.com

12. IPD Sharing Statement

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

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