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

NCT03956771 | Unknown

• 1 other identifier: OCDNF_ICVS2019
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obsessive-Compulsive Disorder; OCD

Keywords

neurofeedback; biofeedback; OCD; obsessive-compulsive disorder; magnetic resonance imaging; functional magnetic resonance imaging; orbitofrontal cortex

Outcome Measures

Primary Outcomes (7)

• Mean change from baseline in Yale-Brown Obsessive Compulsive Scale score.

  Psychometric scale to evaluate obsessive-compulsive symptoms. The total score ranges from 0 to 50 with the following classification: 0-7 sub-clinical symptoms, 8-15 moderate symptoms, 16-31 severe symptoms, and \>= 32 extreme symptoms. This scale can be divided into two subscales: compulsions subscale (score ranging from 0 to 25) and obsessions subscale (score ranging from 0 to 25). The sum of the subscales scores gives the total score of the scale. Lower total and subscale scores represent a better outcome.

  2-3 days before the intervention, 2-3 days after the intervention, and 3 months after the intervention.

• Mean change from baseline in Obsessive-Compulsive Inventory-Revised score.

  Psychometric scale to evaluate obsessive-compulsive symptoms. The total score ranges from 0 to 72. This scale can be divided into six subscales: checking subscale (score ranging from 0 to 12), hoarding subscale (score ranging from 0 to 12), neutralizing subscale (score ranging from 0 to 12), obsessing subscale (score ranging from 0 to 12), ordering subscale (score ranging from 0 to 12), and washing subscale (score ranging from 0 to 12). The sum of the subscales scores gives the total score of the scale. Lower total and subscale scores represent a better outcome.

  2-3 days before the intervention, 2-3 days after the intervention, and 3 months after the intervention.

• Mean change from baseline in Hamilton Anxiety Rating Scale score.

  Psychometric scale to evaluate anxiety symptoms. The total score ranges from 0 to 56 with the following classification: 0-16 mild anxiety symptoms, 17-24 mild to moderate anxiety symptoms, 25-30 moderate to severe anxiety symptoms, and \>= 31 severe anxiety symptoms. Lower total scores represent a better outcome.

  2-3 days before the intervention, 2-3 days after the intervention, and 3 months after the intervention.

• Mean change from baseline in Hamilton Depression Rating Scale score.

  Psychometric scale to evaluate depression symptoms. The total score ranges from 0 to 52 with the following classification: 0-7 no symptoms, 8-16 mild depression symptoms, 17-23 moderate depression symptoms, and \>= 24 severe depression symptoms. Lower total scores represent a better outcome.

  2-3 days before the intervention, 2-3 days after the intervention, and 3 months after the intervention.

• Mean change from baseline in State-Trait Anxiety Inventory score.

  Psychometric scale to evaluate anxiety symptoms. The total score ranges from 40 to 160 with the following classification: 40-76 sub-clinical symptoms, \>= 78 clinical symptoms. This scale can be divided into two subscales: state anxiety subscale (score ranging from 20 to 80) and trait anxiety subscale (score ranging from 20 to 80). The sum of the subscales scores gives the total score of the scale. Lower total and subscale scores represent a better outcome.

  2-3 days before the intervention, 2-3 days after the intervention, and 3 months after the intervention.

• Mean change from baseline in the score of Perceived Stress Scale with 10 items.

  Psychometric scale to evaluate perceived stress symptoms. The total score ranges from 0 to 40. Lower total scores represent a better outcome.

  2-3 days before the intervention, 2-3 days after the intervention, and 3 months after the intervention.

• Mean change from baseline in Emotion Regulation Questionnaire score.

  Psychometric scale to evaluate cognitive regulation and emotional suppression capabilities. The cognitive regulation subscale score ranges from 6 to 42 and the emotional suppression subscale score ranges from 4 to 28. Lower emotional suppression scores and higher cognitive regulation scores represent a better outcome.

  2-3 days before the intervention, 2-3 days after the intervention, and 3 months after the intervention.

Secondary Outcomes (3)

• Difference from baseline in functional connectivity patterns in the brain.

  2-3 days before the intervention, 2-3 days after the intervention

• Differences from baseline in brain grey and white matter structure.

  2-3 days before the intervention, 2-3 days after the intervention

• Mean change from baseline in blood hormonal composition

  2-3 days before the intervention, 2-3 days after the intervention

Study Arms (2)

Real neurofeedback

EXPERIMENTAL

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

Behavioral: Real neurofeedback

Sham neurofeedback

SHAM COMPARATOR

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

Behavioral: Sham neurofeedback

Interventions

Real neurofeedback 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.

Real neurofeedback

Sham neurofeedback 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.

Sham neurofeedback

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Pedro Morgado: lead
• Hospital de Braga: collaborator
• Clinical Academic Center (2CA): collaborator

Study Sites (1)

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

Braga, Gualtar, 4710-057, Portugal

RECRUITING

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

00351 253 604 931; pedromorgado@med.uminho.pt

Sónia Ferreira, M.Sc.

CONTACT

00351 253 604 925; id6533@alunos.uminho.pt

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor, M.D., Ph.D.

Model Details: 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).

Study Record Dates

• First Submitted: May 16, 2019
• First Posted: May 21, 2019
• Study Start: April 5, 2019
• Primary Completion: July 31, 2021
• Study Completion: August 31, 2021
• Last Updated: November 4, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)