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OCDPhase 4NCT06231095

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

A Phase 4 study testing continuous theta burst stimulation - cTBS in people with OCD, run by Wroclaw Medical University at 2 sites in Poland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
OCD
What is being tested?
continuous theta burst stimulation - cTBS
Type of treatment
Medical device
How many people
40 participants
Where
2 sitesPoland
Study dates
1 Jul 2023to 6 Jan 2024
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

Poland2 sites
  • Department of Psychaitry Wroclaw Medical University

    Wroclaw, Lower Silesian Voivodeship, 50-367

  • Deprtment of Psychiatry

    Wroclaw, Lower Silesian Voivodeship, 50-367

Other trials in Poland

About this study

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:

Read more

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

Read the detailed description

Transcranial Magnetic Stimulation (TMS) is an accepted non-invasive method of neurostimulation. Evidence has demonstrated that TMS allows for the reduction of depression symptoms, and an increasing number of reports support its efficacy in reducing symptoms of obsessive-compulsive disorder (OCD). There is a limited body of clinical research available on the mechanisms of TMS action. Neuroplasticity refers to the capacity of neural tissue to form new connections for the purpose of reorganization and adaptation. Brain-Derived Neurotrophic Factor (BDNF) and Cell Adhesion Molecules (CAM) are markers of neuroplasticity. BDNF influences transmission in both excitatory and inhibitory synapses, enhancing neurotransmitter release in cholinergic and dopaminergic neurons. According to the neurotrophic hypothesis, stress may decrease BDNF levels. Serum BDNF concentrations are reduced in untreated patients with depression and normalized by antidepressant treatment. Neuronal CAMs are among the most prevalent proteins, playing a crucial role in synaptic plasticity. Various CAMs appear to interact with BDNF. In depression, both reduced BDNF levels and polysialylated (PSA) neuronal CAMs are observed. Conversely, the levels of Vascular Cell Adhesion Molecule-1 (VCAM-1) and Intracellular Adhesion Molecule-1 (ICAM-1) in depression are inversely correlated with BDNF.

To address this gap, the investiagators aimed to verify the hypothesis that TMS in OCD leads to symptom reduction by inducing neuroplasticity through:

Comparing changes in BDNF and CAM protein concentrations after TMS stimulation in OCD patients before and after stimulation.

Assessing the correlation between changes in BDNF and CAM concentrations and the reduction of psychopathological symptoms.

Evaluating the predictive value of initial BDNF and CAM concentrations.

Study assumptions and planned procedures:

Patients expressing interest in participating will undergo psychiatric assessment to verify the diagnosis of treatment-resistant OCD, assess symptom severity, and exclude TMS contraindications. The study involves a cycle of 35 cTBS stimulations in the supplementary motor area (SMA) over 5 working days, with 7 TMS 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 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
Being tested
continuous theta burst stimulation - cTBS
Keywords
TMS, OCD, cTBS, BDNF, Neuroplasticity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • continuous theta burst stimulation - cTBSDevice

    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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 5 days

  2. 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

    Measured: 30 days

  3. 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

    Measured: 5 days

  4. 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

    Measured: 30days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jan 2024
  2. Study start1 Jul 2023
  3. Primary completion6 Jan 2024
  4. Study completion6 Jan 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06231095
Sponsor's protocol ID
SUBK.C230.23.065
Status last verified
Jan 2024
First submitted
7 Jan 2024
Last updated
30 Jan 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing continuous theta burst stimulation - cTBS in people with OCD, run by Wroclaw Medical University at 2 sites in Poland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

OCD symptoms severity T1 (time frame: 5 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2024; AzTrials last refreshed its copy on 7 Nov 2026.

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