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

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ClinicalTrials.gov Identifier: NCT03956771
Recruitment Status : Recruiting
First Posted : May 21, 2019
Last Update Posted : May 24, 2019
Sponsor:
Collaborators:
Hospital de Braga
Clinical Academic Center (2CA)
Information provided by (Responsible Party):
Pedro Morgado, University of Minho

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.

Condition or disease Intervention/treatment Phase
Obsessive-Compulsive Disorder OCD Behavioral: Real neurofeedback Behavioral: Sham neurofeedback Not Applicable

Detailed Description:
OCD individuals will be recruited at Hospital of Braga, Braga, Portugal, in collaboration with the Psychiatry Unit (n = 45, 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: OCD participants will be blindly split into three groups (n = 15): the real neurofeedback group (group 1, experimental group), the sham neurofeedback group (group 2, sham comparator control group), and the null neurofeedback group (group 3, no intervention 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). Group 3 will not perform the neurofeedback sessions but will also be longitudinally evaluated for symptomatic, blood, and neural changes associated with the disease course without the intervention.
Masking: Double (Participant, Outcomes Assessor)
Masking Description: OCD participants will be blindly split into the three 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
Official Title: Neurofeedback With Magnetic Resonance Imaging (MRI) for OCD Participants With Treatment-resistance
Actual Study Start Date : April 5, 2019
Estimated Primary Completion Date : March 31, 2020
Estimated Study Completion Date : August 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Real neurofeedback
Two sessions of neurofeedback training during 2 weeks (2 distinct days; 36 min per session).
Behavioral: 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.

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

No Intervention: Null neurofeedback
Participants will not perform the neurofeedback intervention nor other interventions.



Primary Outcome Measures :
  1. Mean change from baseline in Yale-Brown Obsessive Compulsive Scale score. [ Time Frame: 2-3 days before the intervention, 2-3 days after the intervention, and 3 months after the intervention. ]
    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. Mean change from baseline in Obsessive-Compulsive Inventory-Revised score. [ Time Frame: 2-3 days before the intervention, 2-3 days after the intervention, and 3 months after the intervention. ]
    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.

  3. Mean change from baseline in Hamilton Anxiety Rating Scale score. [ Time Frame: 2-3 days before the intervention, 2-3 days after the intervention, and 3 months after the intervention. ]
    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.

  4. Mean change from baseline in Hamilton Depression Rating Scale score. [ Time Frame: 2-3 days before the intervention, 2-3 days after the intervention, and 3 months after the intervention. ]
    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.

  5. Mean change from baseline in State-Trait Anxiety Inventory score. [ Time Frame: 2-3 days before the intervention, 2-3 days after the intervention, and 3 months after the intervention. ]
    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.

  6. Mean change from baseline in the score of Perceived Stress Scale with 10 items. [ Time Frame: 2-3 days before the intervention, 2-3 days after the intervention, and 3 months after the intervention. ]
    Psychometric scale to evaluate perceived stress symptoms. The total score ranges from 0 to 40. Lower total scores represent a better outcome.

  7. Mean change from baseline in Emotion Regulation Questionnaire score. [ Time Frame: 2-3 days before the intervention, 2-3 days after the intervention, and 3 months after the intervention. ]
    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 :
  1. Difference from baseline in functional connectivity patterns in the brain. [ Time Frame: 2-3 days before the intervention, 2-3 days after the intervention ]
    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.

  2. Differences from baseline in brain grey and white matter structure. [ Time Frame: 2-3 days before the intervention, 2-3 days after the intervention ]
    Diffusion tensor imaging and anatomical MRI sequences will be applied to assess brain white matter integrity and gray matter morphology, respectively.

  3. Mean change from baseline in blood hormonal composition [ Time Frame: 2-3 days before the intervention, 2-3 days after the intervention ]
    Hemogram and measurement of thyroid-stimulating hormone, cortisol, glucose, and adrenocorticotropic hormone levels in the blood.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03956771


Contacts
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Contact: Pedro Morgado, M.D., Ph.D. 00351 253 604 931 pedromorgado@med.uminho.pt
Contact: Sónia Ferreira, M.Sc. 00351 253 604 925 id6533@alunos.uminho.pt

Locations
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Portugal
Life and Health Sciences Research Institute, School of Medicine, University of Minho Recruiting
Braga, Gualtar, Portugal, 4710-057
Contact: Pedro Morgado, M.D., Ph.D.    00351 253 604 931    pedromorgado@med.uminho.pt   
Contact: Sónia Ferreira, M.Sc.    00351 253 604 925    id6533@alunos.uminho.pt   
Principal Investigator: Pedro Morgado, M.D., Ph.D.         
Sub-Investigator: Sónia Ferreira, M.Sc.         
Sub-Investigator: Maria Picó-Pérez, Ph.D.         
Sponsors and Collaborators
Pedro Morgado
Hospital de Braga
Clinical Academic Center (2CA)
Investigators
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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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Responsible Party: Pedro Morgado, Assistant Professor, M.D., Ph.D., University of Minho
ClinicalTrials.gov Identifier: NCT03956771     History of Changes
Other Study ID Numbers: OCDNF_ICVS2019
First Posted: May 21, 2019    Key Record Dates
Last Update Posted: May 24, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Pedro Morgado, University of Minho:
neurofeedback
biofeedback
OCD
obsessive-compulsive disorder
magnetic resonance imaging
functional magnetic resonance imaging
orbitofrontal cortex

Additional relevant MeSH terms:
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Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Personality Disorders
Mental Disorders
Anxiety Disorders