Priming in Repetitive Transcranial Magnetic Stimulation in the Treatment of Obsessive Compulsive Disorder

September 19, 2023 updated by: Suellen Andrade

Priming in Repetitive Transcranial Magnetic Stimulation (TMSr) in the Adjuvant Treatment of Obsessive Compulsive Disorder (OCD)

Obsessive Compulsive Disorder results in high social impact, affecting quality of life and tending to a chronic course. A considerable proportion of patients, up tp 60%, remain with symptoms even thought treatment is administrated. Therefore, new therapeutic interventions are highly necessary. In this context, repetitive transcranial magnetic stimulation has been used for several psychiatric conditions, including OCD treatment. Moreover, many approaches of neuromodulation seem to reach a better result when used a priming stimulation. In an attemp to optimize particularities of the thecnique applied, this study aims to assess if a priming stimulation with rTMS might impact in a better outcome when compared with rTMS without previous stimulation.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a randomized, double-blind, sham-controlled clinical trial. Neuropsychological tests and a sociodemographic and clinical questionnaire will be used to assess and characterize the subjects. Participants captured by the Laboratory of Studies in Aging and Neuroscience at the Federal University of Paraíba will be divided into 02 groups, each with 16 patients, totaling 50 volunteers: Active - participants who will receive real priming stimulation; Sham - participants who will receive simulated priming stimulation. Participants entered through the eligibility criteria will be randomly allocated in a simple way, at a rate of 1:1.

In the active priming, the parameters are: frequency of 6 Hz for 10 minutos, 80% do Motor Threshold (MT), 20 trains of 5 seconds, with intertrain interval of 25 seconds, a total f 600 stimulations. The group of innactive priming will have the same parameters, but without active atimulation. After this previous stimulation, all participants will receive the main stimulation: 10 sessions of rTMS, each lasting around 20 minutes, for 5 days a week, during two consecutive weeks.

The target area will be the supplementary motor area. Primary outcome will be assessed by change in Yale-Brown Obsessive Compulsive Scale scores. As secondary outcomes, it will be used HAM-A for anxiety, HAM-D for depression, CGI-S for global clinical impression and SF-36 for quality of life.

Study Type

Interventional

Enrollment (Estimated)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Brazil
    • Paraiba
      • João Pessoa, Paraiba, Brazil, 58051-900
        • Recruiting
        • Federal University of Paraíba,Department of Psychology
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Being right-handed;
  • Age between 18 and 60;
  • Diagnose of OCD according to DSM-5;
  • Score in YBOCS between 16 and 23;
  • No change in dose prescription in the previous 3 months;
  • Signature of informed consent term.

Exclusion Criteria:

  • Being pregnant;
  • Having cognitive deficit;
  • Diagnose of drug use disorder;
  • In current psychotherapy (or interrupted in less than 3 months);
  • Diagnose of severe Major Depression;
  • Risk of suicide;
  • Patients with metallic implants in the brain;
  • Epileptics.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active Priming (TMSr)

To apply intervention, it will be used Repetitive Transcranial Magnetic Stimulation Model MagPro R20 (MagVenture Brazil, country Brazil) and the butterfly coil MCF-B70 (MagVenture Brazil, country Brazil).

Each session will last around 20 minutes, and it will be used a 1 Hz frequency, 1200 pulses/day, with 100% of Motor Threshold, once a day, 5 days a week, for two consecutive weeks.

Active Priming group participants will be previously stimulated for 10 minutes (20 trains of 5 seconds with intertrain interval of 25 seconds), with 6Hz frequency over Supplementary Motor Area, receiving 80% of Motor Threshold, with a total of 600 stimulations.
Device: Active Priming

It will be applied an active priming stimulation in the supplementary motor area previously to the main stimulation to analyse if that will enhance the response to TMSr, compared to inactive priming.

To apply intervention, it will be used Repetitive Transcranial Magnetic Stimulation Model MagPro R20 (MagVenture Brazil, country Brazil) and the butterfly coil MCF-B70 (MagVenture Brazil, country Brazil).

Each session will last around 20 minutes, and it will be used a 1 Hz frequency, 1200 pulses/day, with 100% of Motor Threshold, once a day, 5 days a week, for two consecutive weeks.

Active Priming group participants will be previously stimulated for 10 minutes (20 trains of 5 seconds with intertrain interval of 25 seconds), with 6Hz frequency over Supplementary Motor Area, receiving 80% of Motor Threshold, with a total of 600 stimulations.

Other Names:
  • Priming TMSr
Sham Comparator: Sham Priming
Sham Priming group participants will receive a placebo stimulation for ten minutes, with the same parameters and target area as the active group, they will hear the equipament noise and might feel any sensation in the scalp, but there won't be effective stimulation.
Device: Sham Priming
Sham Priming group participants will receive a placebo stimulation for ten minutes, with the same parameters and target area as the active group, they will hear the equipament noise and might feel any sensation in the scalp, but there won't be effective stimulation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Yale-Brown Obsessive Compulsive Scale
Time Frame: From date of randomization (1 week before intervention beginning) and up to 8 weeks
It's a 10-item-scale that evaluates the symptoms' severity of Obsessive Compulsive Disorder. Includes five dimensions that evaluate obsessions and compulsions. The ten itens score from 0 (no symptom) to 4 (extreme symptoms), possibly scoring from 0-20 in obsessions' severity, 0-20 in compulsions' severity, with a total 0-40. YBOCS is considered gold standard in evaluating the severity of OCD symptoms.
From date of randomization (1 week before intervention beginning) and up to 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Hamilton Scale for Depression
Time Frame: From date of randomization (1 week before intervention beginning) and up to 8 weeks
It's a multidimensional scale which allows evaluating depression symptoms. It will be chosen the variant of 17-item, given that the 21-item doesn't add relevant information for our purposes.
From date of randomization (1 week before intervention beginning) and up to 8 weeks
Change in Hamilton Scale for Anxiety
Time Frame: From date of randomization (1 week before intervention beginning) and up to 8 weeks
A 14-item scale that evaluates both physical and psychological aspects of anxiety
From date of randomization (1 week before intervention beginning) and up to 8 weeks
Change in Clinical Global Impression - Scale
Time Frame: From date of randomization (1 week before intervention beginning) and up to 8 weeks
It's divided into two sub-scales, one that evaluates the severity of disease and one that evaluates clinical improvements. Scores from 1 to 7 (in which 7 refers to worse severity or worse improvement).
From date of randomization (1 week before intervention beginning) and up to 8 weeks
Change in Medical Outcomes Study 36 - Item Short Form Health Survey
Time Frame: From date of randomization (1 week before intervention beginning) and up to 8 weeks
Evaluates quality of life and takes into account 36 items, across 8 dimensions.
From date of randomization (1 week before intervention beginning) and up to 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Suellen Andrade

Investigators

  • Principal Investigator: Suellen Andrade, Federal University of Paraíba

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 17, 2022

Primary Completion (Estimated)

September 1, 2023

Study Completion (Estimated)

October 1, 2023

Study Registration Dates

First Submitted

July 14, 2022

First Submitted That Met QC Criteria

September 19, 2023

First Posted (Actual)

September 22, 2023

Study Record Updates

Last Update Posted (Actual)

September 22, 2023

Last Update Submitted That Met QC Criteria

September 19, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PrimingTMS/OCD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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