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
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2021
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2021
CompletedFirst Submitted
Initial submission to the registry
January 3, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 6, 2022
CompletedFirst Posted
Study publicly available on registry
February 3, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2023
CompletedApril 14, 2023
April 1, 2023
10 months
January 3, 2022
April 12, 2023
Conditions
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.
pre-treatment; 1 day post-treatment; Change from baseline score at 1 month
Secondary Outcomes (5)
Obsessive Compulsive Inventory-Revised (OCI-R)
pre-treatment; 1 day post-treatment
Hamilton Depression Scale（HAMD）
pre-treatment; 1 day post-treatment
Hamilton Anxiety Scale（HAMA）
pre-treatment; 1 day post-treatment
Stroop word test
pre-treatment; 1 day post-treatment
Behavioral index TMT=TMT-B reaction time - TMT-A reaction time.
pre-treatment; 1 day post-treatment
Study Arms (3)
accelerated continue theta-burst stimulation
EXPERIMENTALFifty 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.
1-HZ repetition transcranial magnetic stimulation Stimulation
ACTIVE COMPARATORThe 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.
accelerated continue theta-burst stimulation (sham)
SHAM COMPARATORFifty 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.
Interventions
The stimulation mode of TMS is accelerated continue theta-burst stimulation.
The stimulation mode of TMS is 1-Hz repetitive Transcranial magnetic stimulation .
The stimulation mode of TMS is accelerated continue theta-burst stimulation, but without active stimulation.
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of obsessive-compulsive disorder
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Anhui Medical University
Hefei, Anhui, 230032, China
Related Publications (1)
Jiang J, Wan K, Liu Y, Tang Y, Tang W, Liu J, Ma J, Xue C, Chen L, Qian H, Liu D, Shen X, Fan R, Wang Y, Wang K, Ji G, Zhu C. A Controlled Clinical Study of Accelerated High-Dose Theta Burst Stimulation in Patients with Obsessive-Compulsive Disorder. Neural Plast. 2023 Dec 7;2023:2741287. doi: 10.1155/2023/2741287. eCollection 2023.
PMID: 38099081DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
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
January 3, 2022
First Posted
February 3, 2022
Study Start
March 1, 2021
Primary Completion
January 6, 2022
Study Completion
July 1, 2023
Last Updated
April 14, 2023
Record last verified: 2023-04