Clinical trial NCT05221632: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Obsessive-Compulsive Disorder
Accelerated Continue Theta-burst Stimulation
Transcranial Magnetic Stimulation
Functional Magnetic Resonance Imaging
Lead sponsor: Anhui Medical University
Sponsor class: OTHER
First posted: 2022-02-03
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Symptom improvement assessed by the Yale-Brown Obsessive Compulsive Scale
timeFrame: pre-treatment; 1 day post-treatment; Change from baseline score at 1 month
Secondary outcomes:
measure: Obsessive Compulsive Inventory-Revised (OCI-R)
timeFrame: pre-treatment; 1 day post-treatment
measure: Hamilton Depression Scale（HAMD）
timeFrame: pre-treatment; 1 day post-treatment
measure: Hamilton Anxiety Scale（HAMA）
timeFrame: pre-treatment; 1 day post-treatment
measure: Stroop word test
timeFrame: pre-treatment; 1 day post-treatment
measure: Behavioral index TMT=TMT-B reaction time - TMT-A reaction time.
timeFrame: pre-treatment; 1 day post-treatment
Other outcomes:
Locations:
city: Hefei
country: China
facility: Anhui Medical University
state: Anhui
Study officials:
References: