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

NCT ID: NCT05221632

Last Updated: 2023-04-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-01

Study Completion Date

2023-07-01

Brief Summary

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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

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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.

Conditions

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Obsessive-Compulsive Disorder Accelerated Continue Theta-burst Stimulation Transcranial Magnetic Stimulation Functional Magnetic Resonance Imaging

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Accelerated transcranial magnetic stimulation with real coil

Intervention Type DEVICE

The stimulation mode of TMS is accelerated continue theta-burst stimulation.

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.

Group Type ACTIVE_COMPARATOR

Transcranial magnetic stimulation with real coil

Intervention Type DEVICE

The stimulation mode of TMS is 1-Hz repetitive Transcranial magnetic stimulation .

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.

Group Type SHAM_COMPARATOR

Transcranial magnetic stimulation with sham coil

Intervention Type DEVICE

The stimulation mode of TMS is accelerated continue theta-burst stimulation, but without active stimulation.

Interventions

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Accelerated transcranial magnetic stimulation with real coil

The stimulation mode of TMS is accelerated continue theta-burst stimulation.

Intervention Type DEVICE

Transcranial magnetic stimulation with real coil

The stimulation mode of TMS is 1-Hz repetitive Transcranial magnetic stimulation .

Intervention Type DEVICE

Transcranial magnetic stimulation with sham coil

The stimulation mode of TMS is accelerated continue theta-burst stimulation, but without active stimulation.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Anhui Medical University

OTHER

Sponsor Role lead

Responsible Party

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Chunyan Zhu

A/Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Anhui Medical University

Hefei, Anhui, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Chunyan Zhu, professor

Role: CONTACT

+86-0551-62923704

Facility Contacts

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Chunyan Zhu, professor

Role: primary

+86-0551-62923704

References

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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.

Reference Type DERIVED
PMID: 38099081 (View on PubMed)

Other Identifiers

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precise high-dose OCD

Identifier Type: -

Identifier Source: org_study_id

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