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

Primary Purpose

Obsessive-Compulsive Disorder

Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Active Priming
Sham Priming
Sponsored by
Suellen Andrade
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obsessive-Compulsive Disorder focused on measuring priming, supplementary motor area, obsessive-compulsive disorder, transcranial magnetic stimulation

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Federal University of Paraíba,Department of PsychologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Active Priming (TMSr)

Sham Priming

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in Yale-Brown Obsessive Compulsive Scale
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.

Secondary Outcome Measures

Change in Hamilton Scale for Depression
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.
Change in Hamilton Scale for Anxiety
A 14-item scale that evaluates both physical and psychological aspects of anxiety
Change in Clinical Global Impression - Scale
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).
Change in Medical Outcomes Study 36 - Item Short Form Health Survey
Evaluates quality of life and takes into account 36 items, across 8 dimensions.

Full Information

First Posted
July 14, 2022
Last Updated
September 19, 2023
Sponsor
Suellen Andrade
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1. Study Identification

Unique Protocol Identification Number
NCT06049706
Brief Title
Priming in Repetitive Transcranial Magnetic Stimulation in the Treatment of Obsessive Compulsive Disorder
Official Title
Priming in Repetitive Transcranial Magnetic Stimulation (TMSr) in the Adjuvant Treatment of Obsessive Compulsive Disorder (OCD)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 17, 2022 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Suellen Andrade

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obsessive-Compulsive Disorder
Keywords
priming, supplementary motor area, obsessive-compulsive disorder, transcranial magnetic stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment Participants will be divided into 02 groups, each with 16 patients, totaling 32 volunteers: Active - participants who will receive real priming stimulation; Sham - participants who will receive simulated priming stimulation. Participants entered into the study through the eligibility criteria will be randomly allocated in a simple way, at a rate of 1:1.
Masking
ParticipantInvestigator
Masking Description
Duble (Participant, Investigator) All examiners will be blinded to the type of treatment the patient received (active stimulation or sham) and other assessments. Thus, all guidelines established by CONSORT 2010 (Consolidated Standards of Reporting Trials) will be complied with variable control following systematized and countersigned procedures: random sequence generation, allocation concealment, blinding of participants and professionals, blinding of outcome evaluators and attrition bias (loss analysis using the last observation carried forward method)
Allocation
Randomized
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active Priming (TMSr)
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham Priming
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Active Priming
Other Intervention Name(s)
Priming TMSr
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Sham Priming
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Yale-Brown Obsessive Compulsive Scale
Description
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.
Time Frame
From date of randomization (1 week before intervention beginning) and up to 8 weeks
Secondary Outcome Measure Information:
Title
Change in Hamilton Scale for Depression
Description
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.
Time Frame
From date of randomization (1 week before intervention beginning) and up to 8 weeks
Title
Change in Hamilton Scale for Anxiety
Description
A 14-item scale that evaluates both physical and psychological aspects of anxiety
Time Frame
From date of randomization (1 week before intervention beginning) and up to 8 weeks
Title
Change in Clinical Global Impression - Scale
Description
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).
Time Frame
From date of randomization (1 week before intervention beginning) and up to 8 weeks
Title
Change in Medical Outcomes Study 36 - Item Short Form Health Survey
Description
Evaluates quality of life and takes into account 36 items, across 8 dimensions.
Time Frame
From date of randomization (1 week before intervention beginning) and up to 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Suellen Andrade
Phone
986046032
Ext
55 83
Email
suellenandrade@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suellen Andrade
Organizational Affiliation
Federal University of Paraiba
Official's Role
Principal Investigator
Facility Information:
Facility Name
Federal University of Paraíba,Department of Psychology
City
João Pessoa
State/Province
Paraiba
ZIP/Postal Code
58051-900
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Suellen Andrade, Phd
Phone
986046032
Ext
5583
Email
suellenadrade@gmail.com
First Name & Middle Initial & Last Name & Degree
Raissa Fonseca
Phone
999501512
Ext
5583
Email
raissaalexandria@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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