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

A

Anhui Medical University

Status

Enrolling

Conditions

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

Treatments

Device: Transcranial magnetic stimulation with real coil
Device: Accelerated transcranial magnetic stimulation with real coil
Device: Transcranial magnetic stimulation with sham coil

Study type

Interventional

Funder types

Other

Identifiers

NCT05221632
precise high-dose OCD

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 estimated patients

Sex

All

Ages

18 to 45 years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

60 participants in 3 patient groups

accelerated continue theta-burst stimulation
Experimental group
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.
Treatment:
Device: Accelerated transcranial magnetic stimulation with real coil
1-HZ repetition transcranial magnetic stimulation Stimulation
Active Comparator group
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.
Treatment:
Device: Transcranial magnetic stimulation with real coil
accelerated continue theta-burst stimulation (sham)
Sham Comparator group
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.
Treatment:
Device: Transcranial magnetic stimulation with sham coil

Trial contacts and locations

1

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Central trial contact

Chunyan Zhu, professor

Data sourced from clinicaltrials.gov

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