Clinical trial NCT06049706: 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
Overall status: RECRUITING
Phase: NA
Conditions: Obsessive-Compulsive Disorder
Keywords: priming
supplementary motor area
obsessive-compulsive disorder
transcranial magnetic stimulation
Lead sponsor: Federal University of Paraíba
Sponsor class: OTHER
First posted: 2023-09-22
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in Yale-Brown Obsessive Compulsive Scale
timeFrame: From date of randomization (1 week before intervention beginning) and up to 8 weeks
Secondary outcomes:
measure: Change in Hamilton Scale for Depression
timeFrame: From date of randomization (1 week before intervention beginning) and up to 8 weeks
measure: Change in Hamilton Scale for Anxiety
timeFrame: From date of randomization (1 week before intervention beginning) and up to 8 weeks
measure: Change in Clinical Global Impression - Scale
timeFrame: From date of randomization (1 week before intervention beginning) and up to 8 weeks
measure: Change in Medical Outcomes Study 36 - Item Short Form Health Survey
timeFrame: From date of randomization (1 week before intervention beginning) and up to 8 weeks
Other outcomes:
Locations:
city: João Pessoa
country: Brazil
facility: Federal University of Paraíba,Department of Psychology
state: Paraiba
Study officials:
affiliation: Federal University of Paraiba
name: Suellen Andrade
role: PRINCIPAL_INVESTIGATOR
References: