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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 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-01-30

No results posted yet for this study

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

Interventions

DEVICE

continuous theta burst stimulation - cTBS

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.

Sponsors & Collaborators

  • Wroclaw Medical University

    lead OTHER

Principal Investigators

  • Błażej Misiak, Prof · Department of Psychaitry Wroclaw Medical Univeristy, Pasteura 10 Str Wrocław Poland

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-01
Primary Completion
2024-01-06
Completion
2024-01-06

Countries

  • Poland

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06231095 on ClinicalTrials.gov