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

NCT ID: NCT06049706

Last Updated: 2023-09-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-17
• Study Completion Date: 2023-10-31

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.

Conditions

Obsessive-Compulsive Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Active Priming

Intervention Type: DEVICE

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.

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.

Group Type: SHAM_COMPARATOR

Sham Priming

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Other Intervention Names

Priming TMSr

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Suellen Andrade

OTHER

Sponsor Role: lead

Responsible Party

Suellen Andrade

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Suellen Andrade

Role: PRINCIPAL_INVESTIGATOR

Federal University of Paraiba

Locations

Federal University of Paraíba,Department of Psychology

João Pessoa, Paraíba, Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Suellen Andrade

Role: CONTACT

suellenandrade@gmail.com

986046032 ext. 55 83

Facility Contacts

Suellen Andrade, Phd

Role: primary

suellenadrade@gmail.com

986046032 ext. 5583

Raissa Fonseca

Role: backup

raissaalexandria@gmail.com

999501512 ext. 5583

Other Identifiers

PrimingTMS/OCD

Identifier Type: -

Identifier Source: org_study_id