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

Obsessive-Compulsive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06049706
• Other study ID #: PrimingTMS/OCD
• Status: Recruiting
• Phase: N/A
• Start date: May 17, 2022
• Est. completion date: October 2023

Study information

• Verified date: September 2023
• Source: Federal University of Paraíba
• Contact: Suellen Andrade
• Phone: 986046032
• Email: suellenandrade[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: October 2023
• Est. primary completion date: September 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obsessive-Compulsive Disorder

Intervention

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.
• 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.

Locations

Country	Name	City	State
Brazil	Federal University of Paraíba,Department of Psychology	João Pessoa	Paraiba

Sponsors (1)

Lead Sponsor	Collaborator
Suellen Andrade

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	From date of randomization (1 week before intervention beginning) and up to 8 weeks
Secondary	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.	From date of randomization (1 week before intervention beginning) and up to 8 weeks
Secondary	Change in Hamilton Scale for Anxiety	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
Secondary	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).	From date of randomization (1 week before intervention beginning) and up to 8 weeks
Secondary	Change in Medical Outcomes Study 36 - Item Short Form Health Survey	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