Neurofeedback for Treatment-resistant Obsessive-compulsive Disorder (OCD)

Pedro Morgado

Status: Unknown

Conditions: Obsessive-Compulsive Disorder; OCD

Treatments: Behavioral: Real neurofeedback; Behavioral: Sham neurofeedback

Study type: Interventional

Funder types: Other

Identifiers

NCT03956771

OCDNF_ICVS2019

Details and patient eligibility

About

The aim of this study is to teach participants with a OCD diagnosis and treatment-resistance how to decrease the response from a brain region involved in the disease by using a technique called neurofeedback. While using this technique, the participants visualize their own brain response in a screen during a MRI exam. Participants will learn strategies to decrease brain responses. The neurofeedback technique is non-invasive, without known risks to participants. With this study, it is expect that the neurofeedback training over 2 weeks (2 sessions) will reduce the OCD symptoms when compared to a control intervention based on neurofeedback's placebo effects.

Full 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 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Primary diagnosis of current OCD according to the fifth Diagnostic and Statistical Manual of Mental Disorders;
• Treatment resistance (≥ 3 selective serotonin reuptake inhibitors in proper dose for ≥ 12 weeks).

Exclusion criteria

• Concomitant psychiatric or neurological illness;
• Substance abuse/dependence in the past 6 months (except nicotine/caffeine);
• Acute suicidal ideation;
• Psychotropic medication (except selective serotonin reuptake inhibitors, anafranil, or low-dose hypnotic or anxiolytic taken occasionally);
• MRI contraindications (pregnancy, major head trauma, severe claustrophobia, severe back pain, ferromagnetic materials/prostheses/implants inside the body, or other).

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups

Real neurofeedback

Experimental group

Description:

Two sessions of neurofeedback training during 2 weeks (2 distinct days; 36 min per session).

Treatment:

Behavioral: Real neurofeedback

Sham neurofeedback

Sham Comparator group

Description:

Two sessions of placebo/control neurofeedback training during 2 weeks (2 distinct days; 36 min per session).

Treatment:

Behavioral: Sham neurofeedback