Does TMS Affect Neuroplasticity? The Role of Brain-derived Neurotrophic Factor and Neuronal Cell Adhesion Molecules - an Intensive Clinical Protocol Among Patients With Obsessive-compulsive Disorders

NCT06231095 | Completed Phase 4 DMC

• 1 other identifier: SUBK.C230.23.065
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

Patients expressing interest in participating will undergo psychiatric assessment to verify the diagnosis of treatment-resistant obsessive-compulsive disorder (OCD), assess symptom severity, and exclude TMS contraindications. The study involves a cycle of 35 continuous theta burst stimulations (cTBS) in the supplementary motor area (SMA) over 5 working days, with 7 stimulation sessions each day lasting 40 seconds. A 1-hour break between sessions will be observed, and each session will comprise 600 pulses at 90% of the motor threshold intensity. Biochemical analysis of blood serum from 40 patients will be conducted at three time points in an open-label study with active TMS stimulation: T0 - before starting stimulation T1 - after completing stimulation T2 - 1 month after completing stimulation Inclusion criteria: Diagnosis of depression or OCD according to the 10th revision of the International Statistical Classification of Diseases and Related Health Problems (ICD-10) criteria, Hamilton Depression Rating Scale (HAM-D) score \> 16 points, or Yale-Brown Obsessive Compulsive Scale (Y-BOCS) score \> 19 points; age 18-70 years. Exclusion criteria: Contraindications to TMS procedures, lack of informed consent, and documented persistent non-cooperation with treatment

Conditions

OCD

Keywords

TMS; OCD; cTBS; BDNF; Neuroplasticity

Outcome Measures

Primary Outcomes (4)

• OCD symptoms severity T1

  OCD symptoms severity - Yale Brown Obsessive-Compulsive Scale (Y-BOCS) scoring from 0-40. Higher score means higher severity of symptoms

  5 days

• OCD symptoms severity T2

  OCD symptoms severity - OCD symptoms severity - Yale Brown Obsessive-Compulsive Scale (Y-BOCS) scoring from 0-40. Higher score means higher severity of symptoms

  30 days

• depressive symptoms severity T1

  depressive symptoms severity -Montgomery-Asberg Depression Rating Scale (MADRS) scoring from 0-60. Higher score means higher severity of depressive symptoms

  5 days

• depressive symptoms severity T2

  depressive symptoms severity - depressive symptoms severity -Montgomery-Asberg Depression Rating Scale (MADRS) scoring from 0-60. Higher score means higher severity of depressive symptoms

  30days

Interventions

continuous theta burst stimulation - cTBS DEVICE

Continuous theta burst stimulation (cTBS) is a quicker and potentially more effective technique to reduce cortical hyperactivity than repetitive transcranial magnetic stimulation (rTMS). The study involves a cycle of 35 cTBS stimulations in the supplementary motor area (SMA) over 5 working days, with 7 stimulation sessions each day lasting 40 seconds. A 1-hour break between sessions will be observed, and each session will comprise 600 pulses at 90% of the motor threshold intensity.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of depression or OCD according to ICD-10 criteria,
• Yale-Brown Obsessive Compulsive Scale (Y-BOCS) score \> 19 points;
• age 18-70 years.

You may not qualify if:

• Contraindications to TMS procedures,
• lack of informed consent, and documented persistent non-cooperation with treatment.

Sponsors & Collaborators

• Wroclaw Medical University: lead

Study Sites (2)

Department of Psychaitry Wroclaw Medical University

Wroclaw, Lower Silesian Voivodeship, 50-367, Poland

Location

Deprtment of Psychiatry

Wroclaw, Lower Silesian Voivodeship, 50-367, Poland

Location

Study Officials

• Błażej Misiak, Prof

  Department of Psychaitry Wroclaw Medical Univeristy, Pasteura 10 Str Wrocław Poland

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 7, 2024
• First Posted: January 30, 2024
• Study Start: July 1, 2023
• Primary Completion: January 6, 2024
• Study Completion: January 6, 2024
• Last Updated: January 30, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

PL (2)