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

NCT ID: NCT03956771

Last Updated: 2020-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-05

Study Completion Date

2021-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Obsessive-Compulsive Disorder OCD

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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).
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
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.

Study Groups

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Real neurofeedback

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

Group Type EXPERIMENTAL

Real neurofeedback

Intervention Type BEHAVIORAL

Regulation of brain activity in real-time with feedback from brain activity measured with MRI from the orbitofrontal cortex of the participant him/herself. Participants receive feedback of their own brain activity in a screen with pictures. Participants are instructed to try to decrease the pictures transparency to reduce the orbitofrontal cortical activity. Psychotherapy strategies to decrease brain responses will be teach to the participants before the intervention.

Sham neurofeedback

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

Group Type SHAM_COMPARATOR

Sham neurofeedback

Intervention Type BEHAVIORAL

Regulation of brain activity in real-time with feedback from brain activity measured with MRI from the orbitofrontal cortex of other participant. Participants receive feedback of other participant' brain activity in a screen with pictures. Participants are instructed to try to decrease the pictures transparency to reduce the orbitofrontal cortex activity. Psychotherapy strategies to decrease brain responses will be teach to the participants before the intervention.

Interventions

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Real neurofeedback

Regulation of brain activity in real-time with feedback from brain activity measured with MRI from the orbitofrontal cortex of the participant him/herself. Participants receive feedback of their own brain activity in a screen with pictures. Participants are instructed to try to decrease the pictures transparency to reduce the orbitofrontal cortical activity. Psychotherapy strategies to decrease brain responses will be teach to the participants before the intervention.

Intervention Type BEHAVIORAL

Sham neurofeedback

Regulation of brain activity in real-time with feedback from brain activity measured with MRI from the orbitofrontal cortex of other participant. Participants receive feedback of other participant' brain activity in a screen with pictures. Participants are instructed to try to decrease the pictures transparency to reduce the orbitofrontal cortex activity. Psychotherapy strategies to decrease brain responses will be teach to the participants before the intervention.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital de Braga

OTHER

Sponsor Role collaborator

Clinical Academic Center (2CA)

UNKNOWN

Sponsor Role collaborator

Pedro Morgado

OTHER

Sponsor Role lead

Responsible Party

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Pedro Morgado

Assistant Professor, M.D., Ph.D.

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Pedro Morgado, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Life and Health Sciences Research Institute (ICVS), School of Medicine, University of Minho; ICVS/3B's - PT Government Associate Laboratory; Braga, Portugal

Locations

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Life and Health Sciences Research Institute, School of Medicine, University of Minho

Braga, Gualtar, Portugal

Site Status RECRUITING

Countries

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Portugal

Central Contacts

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Pedro Morgado, M.D., Ph.D.

Role: CONTACT

[email protected]
00351 253 604 931

Sónia Ferreira, M.Sc.

Role: CONTACT

[email protected]
00351 253 604 925

Facility Contacts

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Pedro Morgado, M.D., Ph.D.

Role: primary

[email protected]
00351 253 604 931

Sónia Ferreira, M.Sc.

Role: backup

[email protected]
00351 253 604 925

Other Identifiers

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OCDNF_ICVS2019

Identifier Type: -

Identifier Source: org_study_id