Obsessive-Compulsive DisorderNCT03956771
Neurofeedback for Treatment-resistant Obsessive-compulsive Disorder (OCD)
A study testing Real neurofeedback in people with Obsessive-Compulsive Disorder and OCD, run by Pedro Morgado at 1 site in Portugal.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obsessive-Compulsive Disorder, OCD
- What is being tested?
- Real neurofeedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 sitePortugal
- Study dates
- 5 Apr 2019to 31 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Portugal1 site, 1 recruiting
- Recruiting
Life and Health Sciences Research Institute, School of Medicine, University of Minho
Braga, Gualtar, 4710-057
Pedro Morgado, M.D., Ph.D., 00351 253 604 931, pedromorgado@med.uminho.pt
Sónia Ferreira, M.Sc., 00351 253 604 925, id6533@alunos.uminho.pt
About this study
Official title: Neurofeedback With Magnetic Resonance Imaging (MRI) for OCD Participants With Treatment-resistance
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.
Read the 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.
- Conditions
- Obsessive-Compulsive Disorder, OCD
- Being tested
- Real neurofeedback, Sham neurofeedback
- Keywords
- neurofeedback, biofeedback, OCD, obsessive-compulsive disorder, magnetic resonance imaging, functional magnetic resonance imaging, orbitofrontal cortex
- Medical subject headings
- Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real neurofeedbackBehavioural
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 neurofeedbackBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Real neurofeedback | Experimental | Two sessions of neurofeedback training during 2 weeks (2 distinct days; 36 min per session). Receives: Behavioral: Real neurofeedback |
| Sham neurofeedback | Sham comparator | Two sessions of placebo/control neurofeedback training during 2 weeks (2 distinct days; 36 min per session). Receives: Behavioral: Sham neurofeedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
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.
Measured: 2-3 days before the intervention, 2-3 days after the intervention
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.
Measured: 2-3 days before the intervention, 2-3 days after the intervention
Mean change from baseline in blood hormonal composition
Hemogram and measurement of thyroid-stimulating hormone, cortisol, glucose, and adrenocorticotropic hormone levels in the blood.
Measured: 2-3 days before the intervention, 2-3 days after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2019
- Study start5 Apr 2019
- Primary completion31 Jul 2021 (estimated)
- Study completion31 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obsessive-Compulsive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pedro Morgado
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital de Braga, Clinical Academic Center (2CA)
- Responsible party
- Sponsor-investigator, Pedro Morgado, University of Minho
- Investigators
- Pedro Morgado, M.D., Ph.D., Principal investigator, Life and Health Sciences Research Institute (ICVS), School of Medicine, University of Minho; ICVS/3B's - PT Government Associate Laboratory; Braga, Portugal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03956771
- Sponsor's protocol ID
- OCDNF_ICVS2019
- Status last verified
- Nov 2020
- First submitted
- 16 May 2019
- Last updated
- 4 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurofeedback With Magnetic Resonance Imaging (MRI) for OCD Participants With Treatment-resistance
- ClinicalTrials.gov ID
- NCT03956771
- Acronym / sponsor ID
- OCDNF_ICVS2019
- Conditions
- Obsessive-Compulsive Disorder, OCD
- Keywords
- neurofeedback, biofeedback, OCD, obsessive-compulsive disorder, magnetic resonance imaging, functional magnetic resonance imaging, orbitofrontal cortex
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Pedro MorgadoUniversity, hospital or other
- Collaborators
- Hospital de Braga, Clinical Academic Center (2CA)
- Study start
- 5 Apr 2019 (actual)
- Primary completion
- 31 Jul 2021 (estimated)
- Study completion
- 31 Aug 2021 (estimated)
- First posted
- 21 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Real neurofeedback | Experimental | Behavioral: Real neurofeedbackTwo sessions of neurofeedback training during 2 weeks (2 distinct days; 36 min per session). |
| Sham neurofeedback | Sham comparator | Behavioral: Sham neurofeedbackTwo sessions of placebo/control neurofeedback training during 2 weeks (2 distinct days; 36 min per session). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Real neurofeedbackRegulation 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. | Behavioural | Real neurofeedback |
| Sham neurofeedbackRegulation 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. | Behavioural | Sham neurofeedback |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
3 secondary outcomes
Difference from baseline in functional connectivity patterns in the brain.
Time frame: 2-3 days before the intervention, 2-3 days after the intervention
Differences from baseline in brain grey and white matter structure.
Time frame: 2-3 days before the intervention, 2-3 days after the intervention
Mean change from baseline in blood hormonal composition
Time frame: 2-3 days before the intervention, 2-3 days after the intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pedro Morgado, M.D., Ph.D. principal investigator
Life and Health Sciences Research Institute (ICVS), School of Medicine, University of Minho; ICVS/3B's - PT Government Associate Laboratory; Braga, Portugal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Real neurofeedback in people with Obsessive-Compulsive Disorder and OCD, run by Pedro Morgado at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pedro Morgado, M.D., Ph.D. (00351 253 604 931, pedromorgado@med.uminho.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2020.