Neurofeedback for Treatment-resistant Obsessive-compulsive Disorder (OCD)
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 45
Summary
- Conditions
- Obsessive Compulsive Disorder
- OCD
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: Non-RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: OCD participants will be blindly split into two groups (n = 15): the real neurofeedback group (group 1, experimental group) and the sham neurofeedback group (group 2, sham comparator control group). Group 1 will receive feedback information from real activity from the target brain region, while group 2 will receive false feedback not matching real brain responses to account for placebo effects (from other participant's data).Masking: Double (Participant, Outcomes Assessor)Masking Description: OCD participants will be blindly split into the two groups before the neurofeedback intervention. The psychologist evaluating the psychometric outcomes will be blind to the type of intervention of each participant.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 65 years
- Gender
- Both males and females
Description
OCD individuals will be recruited at Hospital of Braga, Braga, Portugal, in collaboration with the Psychiatry Unit (n = 30, nonrandom convenience sample based on effect size of 0.30, alpha = beta = 0.05, and ANOVA repeated measures within-between interaction). Some participants may quit the study bu...
OCD individuals will be recruited at Hospital of Braga, Braga, Portugal, in collaboration with the Psychiatry Unit (n = 30, nonrandom convenience sample based on effect size of 0.30, alpha = beta = 0.05, and ANOVA repeated measures within-between interaction). Some participants may quit the study but sample size was predetermined considering a putative 30 percent dropout rate. Clinical history will be assessed (sociodemographic information, disease onset and severity, and previous/current treatments). The participants' neuropsychological state, the blood hormonal levels, and brain function and structure as baseline measures before and after the neurofeedback intervention will be assessed. Two MRI neurofeedback sessions will be performed during 2 weeks (2 distinct days; 36 min per session) in a 3 T MRI scanner. Data analysis will be performed with a repeated measures design (baseline and after neurofeedback) between the groups to measure brain, blood, and neuropsychological changes. Patients will be supervised by a physician to track putative complications/adverse effects during the intervention. The participation will be immediately interrupted in case of adverse reactions or symptomatic worsening and a physician will follow the participants to provide the appropriated care.
Tracking Information
- NCT #
- NCT03956771
- Collaborators
- Hospital de Braga
- Clinical Academic Center (2CA)
- Investigators
- Principal Investigator: Pedro Morgado, M.D., Ph.D. Life and Health Sciences Research Institute (ICVS), School of Medicine, University of Minho; ICVS/3B's - PT Government Associate Laboratory; Braga, Portugal
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