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NCT Number: NCT03207633

Low Frequency TMS on DLPFC and OFC in OCD Patients

This study aims to evaluate the therapeutic effect of low frequency rTMS over the right DLPFC, versus right OFC versus Sham group of obsessive-compulsive disorder (OCD) patients. Sixty patients will be recruited from the out-patient psychiatric clinic of a university hospital, and randomized into three equal groups. The 1st group will receive 10 sessions of low frequency rTMS targeting right DLPFC by means of a butterfly coil, 120% RMT, 1 Hz, 3 trains, each of 500 pulses with a 40 seconds inter-train interval allowing the coil to cool. The 2nd group will receive 10 sessions of low-frequency rTMS over the right orbitofrontal cortex (OFC), the international 10-20 EEG system will be used to position the coil over the right OFC, at the right frontopolar 2 (Fp2) electrode site, using the following parameters: 120% motor threshold, 1 Hz, 3 trains, each of 500 pulses with a 40 seconds inter-train interval allowing the coil to cool. The 3rd group will receive sham stimulations with the same pulse delivery as the other groups but with the coil placed perpendicular to the scalp.

The resting motor threshold (RMT) and cortical silent period (CSP) at different intensities from 110 % to 150 % will be measured before and after the end of sessions. All assessments like (Y-BOCS), (HAM-A), Beck Depression Inventory, (CGI-S), (MoCA) will be performed before and after end of the sessions and 3 months later.

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Key information

Conditions

Psychiatric Disorder Mental Disorders

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eman Khedr

Asyut, 11517, Egypt

About this study

This study aims to evaluate the therapeutic effect of low frequency rTMS over the right DLPFC, versus right OFC versus Sham group of OCD patients. Sixty patients will be recruited from the out-patient psychiatric clinic of a university hospital, the patients will be randomized into three groups (20 patients for each group) using closed envelopes.

The first group (20 patients) will receive 10 sessions of low frequency rTMS targeting right DLPFC by means of a Butterfly coil, The DLPFC stimulation site was defined as the region 5 cm dorsolateral in the same sagittal plane as the optimal site for MT production in the first dorsal interosseous, using the following parameters: 120% RMT, 1 Hz, 3 trains, each of 500 pulses with a 40 seconds inter-train interval allowing the coil to cool.

The second group (20 patients) will receive 10 sessions of low-frequency rTMS over the right orbitofrontal cortex (OFC) by means of a butterfly coil, the international 10-20 EEG system will be used to position the coil over the right OFC, at the right frontopolar 2 (Fp2) electrode site, using the following parameters: 120% motor threshold, 1 Hz, 3 trains, each of 500 pulses with a 40 seconds inter-train interval allowing the coil to cool.

The third group (the sham condition) (20 patients) group will receive sham stimulations with the same pulse delivery as the other groups but with the coil placed perpendicular to the scalp.

The resting motor threshold (RMT) and cortical silent period (CSP) at different intensities from 110 % to 150 % will be measured before and after the end of sessions. All assessments like (Y-BOCS), (HAM-A), Beck Depression Inventory, (CGI-S), (MoCA) will be performed before and after end of the sessions and 3 months later.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • being 18 or over
  • being assigned a Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) or DSM-V diagnosis of OCD by the referring psychiatrist

Exclusion criteria

  • (1) presenting established cognitive or communication problems which makes it challenging to understand the questionnaires and take part in the therapeutic encounters
  • (2) suffering from other severe psychiatric disorders, metabolic, or neurological disorders .
  • (3) Patients with pacemaker, or metallic devices

Treatment and study plan

Repetitive trans-magnetic stimulation (rTMS) on DLPFC

Procedure

Repetitive trans-magnetic stimulation (rTMS) on DLPFC

Repetitive trans-magnetic stimulation (rTMS) on OFC

Procedure

Repetitive trans-magnetic stimulation (rTMS) on OFC

Sham repetitive trans-magnetic stimulation (rTMS)

Procedure

Sham repetitive trans-magnetic stimulation (rTMS)

Primary outcomes

  1. Yale-Brown Obsessive Compulsive Scale (Y-BOCS)

    Time frame: Three months

    Assessment of Obsessive Compulsive disorder using (Y-BOCS)

  2. Hamilton Anxiety Rating Scale (HAM-A)

    Time frame: Three months

    Assessment of anxiety using Hamilton scale

  3. Beck Depression Inventory

    Time frame: Three months

    Assessment of Depression using Beck depression inventory

  4. Clinical Global Impression-Severity scale (CGI-S)

    Time frame: Three months

    Assessment of clinical severity using CGI-S

  5. Montreal Cognitive Assessment (MoCA)

    Time frame: Three months

    Assessment of cognitive function using (MoCA)

Secondary outcomes

  1. Changes of cortical excitability parameters (RMT and CSP)

    Time frame: Ten days

    Measurment of changes of cortical excitability parameters (RMT and CSP) before and after sessions in the three groups.

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Comparative Study of the Therapeutic Effect of Low Frequency TMS on DLPFC and OFC in OCD Patients

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jul 5, 2017
Registry last updated
Sep 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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