NCT05221632

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Anhui Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
DEVICE	Accelerated transcranial magnetic stimulation with real coil	The stimulation mode of TMS is accelerated continue theta-burst stimulation.
DEVICE	Transcranial magnetic stimulation with real coil	The stimulation mode of TMS is 1-Hz repetitive Transcranial magnetic stimulation .
DEVICE	Transcranial magnetic stimulation with sham coil	The stimulation mode of TMS is accelerated continue theta-burst stimulation, but without active stimulation.

Timeline

• Start date: 2021-03-01
• Primary completion: 2022-01-06
• Completion: 2023-07-01
• First posted: 2022-02-03
• Last updated: 2023-04-14

Locations

1 site across 1 country: China