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

Primary Purpose

Obsessive-Compulsive Disorder, OCD

Status
Unknown status
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
Real neurofeedback
Sham neurofeedback
Sponsored by
Pedro Morgado
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obsessive-Compulsive Disorder focused on measuring neurofeedback, biofeedback, OCD, obsessive-compulsive disorder, magnetic resonance imaging, functional magnetic resonance imaging, orbitofrontal cortex

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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).

Sites / Locations

  • Life and Health Sciences Research Institute, School of Medicine, University of MinhoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Real neurofeedback

Sham neurofeedback

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

Difference from baseline in functional connectivity patterns in the brain.
Functional connectivity maps will be obtained with resting state functional MRI sequences to study changes in brain function induced by the intervention, mainly in regions associated with the target region - the orbitofrontal cortex.
Differences from baseline in brain grey and white matter structure.
Diffusion tensor imaging and anatomical MRI sequences will be applied to assess brain white matter integrity and gray matter morphology, respectively.
Mean change from baseline in blood hormonal composition
Hemogram and measurement of thyroid-stimulating hormone, cortisol, glucose, and adrenocorticotropic hormone levels in the blood.

Full Information

First Posted
May 16, 2019
Last Updated
November 3, 2020
Sponsor
Pedro Morgado
Collaborators
Hospital de Braga, Clinical Academic Center (2CA)
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1. Study Identification

Unique Protocol Identification Number
NCT03956771
Brief Title
Neurofeedback for Treatment-resistant Obsessive-compulsive Disorder (OCD)
Official Title
Neurofeedback With Magnetic Resonance Imaging (MRI) for OCD Participants With Treatment-resistance
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 5, 2019 (Actual)
Primary Completion Date
July 31, 2021 (Anticipated)
Study Completion Date
August 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Pedro Morgado
Collaborators
Hospital de Braga, Clinical Academic Center (2CA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obsessive-Compulsive Disorder, OCD
Keywords
neurofeedback, biofeedback, OCD, obsessive-compulsive disorder, magnetic resonance imaging, functional magnetic resonance imaging, orbitofrontal cortex

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantOutcomes 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.
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Real neurofeedback
Arm Type
Experimental
Arm Description
Two sessions of neurofeedback training during 2 weeks (2 distinct days; 36 min per session).
Arm Title
Sham neurofeedback
Arm Type
Sham Comparator
Arm Description
Two sessions of placebo/control neurofeedback training during 2 weeks (2 distinct days; 36 min per session).
Intervention Type
Behavioral
Intervention Name(s)
Real neurofeedback
Intervention Description
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
Intervention Name(s)
Sham neurofeedback
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mean change from baseline in Yale-Brown Obsessive Compulsive Scale score.
Description
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.
Time Frame
2-3 days before the intervention, 2-3 days after the intervention, and 3 months after the intervention.
Title
Mean change from baseline in Obsessive-Compulsive Inventory-Revised score.
Description
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.
Time Frame
2-3 days before the intervention, 2-3 days after the intervention, and 3 months after the intervention.
Title
Mean change from baseline in Hamilton Anxiety Rating Scale score.
Description
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.
Time Frame
2-3 days before the intervention, 2-3 days after the intervention, and 3 months after the intervention.
Title
Mean change from baseline in Hamilton Depression Rating Scale score.
Description
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.
Time Frame
2-3 days before the intervention, 2-3 days after the intervention, and 3 months after the intervention.
Title
Mean change from baseline in State-Trait Anxiety Inventory score.
Description
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.
Time Frame
2-3 days before the intervention, 2-3 days after the intervention, and 3 months after the intervention.
Title
Mean change from baseline in the score of Perceived Stress Scale with 10 items.
Description
Psychometric scale to evaluate perceived stress symptoms. The total score ranges from 0 to 40. Lower total scores represent a better outcome.
Time Frame
2-3 days before the intervention, 2-3 days after the intervention, and 3 months after the intervention.
Title
Mean change from baseline in Emotion Regulation Questionnaire score.
Description
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.
Time Frame
2-3 days before the intervention, 2-3 days after the intervention, and 3 months after the intervention.
Secondary Outcome Measure Information:
Title
Difference from baseline in functional connectivity patterns in the brain.
Description
Functional connectivity maps will be obtained with resting state functional MRI sequences to study changes in brain function induced by the intervention, mainly in regions associated with the target region - the orbitofrontal cortex.
Time Frame
2-3 days before the intervention, 2-3 days after the intervention
Title
Differences from baseline in brain grey and white matter structure.
Description
Diffusion tensor imaging and anatomical MRI sequences will be applied to assess brain white matter integrity and gray matter morphology, respectively.
Time Frame
2-3 days before the intervention, 2-3 days after the intervention
Title
Mean change from baseline in blood hormonal composition
Description
Hemogram and measurement of thyroid-stimulating hormone, cortisol, glucose, and adrenocorticotropic hormone levels in the blood.
Time Frame
2-3 days before the intervention, 2-3 days after the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pedro Morgado, M.D., Ph.D.
Phone
00351 253 604 931
Email
pedromorgado@med.uminho.pt
First Name & Middle Initial & Last Name or Official Title & Degree
Sónia Ferreira, M.Sc.
Phone
00351 253 604 925
Email
id6533@alunos.uminho.pt
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pedro Morgado, M.D., Ph.D.
Organizational Affiliation
Life and Health Sciences Research Institute (ICVS), School of Medicine, University of Minho; ICVS/3B's - PT Government Associate Laboratory; Braga, Portugal
Official's Role
Principal Investigator
Facility Information:
Facility Name
Life and Health Sciences Research Institute, School of Medicine, University of Minho
City
Braga
State/Province
Gualtar
ZIP/Postal Code
4710-057
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pedro Morgado, M.D., Ph.D.
Phone
00351 253 604 931
Email
pedromorgado@med.uminho.pt
First Name & Middle Initial & Last Name & Degree
Sónia Ferreira, M.Sc.
Phone
00351 253 604 925
Email
id6533@alunos.uminho.pt
First Name & Middle Initial & Last Name & Degree
Pedro Morgado, M.D., Ph.D.
First Name & Middle Initial & Last Name & Degree
Sónia Ferreira, M.Sc.
First Name & Middle Initial & Last Name & Degree
Maria Picó-Pérez, Ph.D.

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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