DepressionCNF-ruminationNCT04941066
Cognitive Process-based Real-time fMRI Neurofeedback in MDD and Rumination
A study testing Active neurofeedback in people with Depression and Anxiety, run by Laureate Institute for Brain Research, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to assess the feasibility and efficacy of real-time fMRI neurofeedback for rumination. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression, Anxiety
- What is being tested?
- Active neurofeedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2021to 31 Mar 2022
- 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
- Good general health
- DSM-5 diagnosis of major depressive disorder (MDD)
Who cannot join
- General Exclusion Criteria:
- Pregnancy
- Medical Conditions:
- Moderate to severe traumatic brain injury (>30 min. loss of consciousness or >24 hours posttraumatic amnesia) or other neurocognitive disorder with evidence of neurological deficits.
- Presence of co-morbid medical conditions not limited to but including cardiovascular (e.g., history of acute coronary event, stroke) and neurological diseases (e.g., Parkinson's disease), as well as pain disorders.
- Presence of an uncontrolled medical condition that is deemed by the investigators to interfere with the proposed study procedures, or to put the study participant at undue risk.
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- Psychiatric Disorders:
- Current severe suicidal ideation or attempt within the past 12 months.
- Psychosis
- Bipolar disorder
- Substance abuse or dependence within the previous 6 months
- Contraindications for MRI:
- Bodily implants of unsafe paramagnetic materials such as pace-makers and aneurysm clips.
- Claustrophobia that is severe enough to preclude MRI scanning.
- Medications:
- Evidence of recreational drug use from a urine test.
Trial locations and contacts
1 site in 1 country.
United States1 site
Laureate Institute for Brain Research
Tulsa, Oklahoma, 74136
About this study
The purpose of this study is to assess the feasibility and efficacy of real-time fMRI neurofeedback for rumination.
Read the detailed description
Neuroimaging MRI techniques for measuring brain structure, tissue composition, and Blood Oxygenation Level Dependent functional Magnetic Resonance imaging (BOLD fMRI) will be used to measure task-dependent and task-independent brain hemodynamic and electrophysiological changes in human subjects with major depressive disorders (MDD).
After being informed about the study and potential risks, all participants giving written informed consent will undergo one session of the cognitive process-based fMRI neurofeedback (CNF) targeting the rumination-related brain functional connectivity, and a one-week follow-up. Participants will be randomized in a double-blind manner (participant and investigator) in a 1:1 ratio to Active (receiving feedback from their own brain activity) or Sham (receiving artificially generated feedback).
- Conditions
- Depression, Anxiety
- Being tested
- Active neurofeedback, Sham neurofeedback
- Keywords
- neurofeedback, real-time fMRI, rumination
- Medical subject headings
- Depression, Anxiety Disorders, Rumination Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active neurofeedbackBehavioural
The session will be done on an individual basis. The active group will receive neurofeedback training from the rumination-related brain functional connectivity.
Sham neurofeedbackBehavioural
The session will be done on an individual basis. The sham group will receive neurofeedback training from an artificially generated random feedback signal.
| Study group | Role | What they receive |
|---|---|---|
| Active neurofeedback | Experimental | Receiving feedback signals from the rumination-related brain functional connectivity. Receives: Behavioral: Active neurofeedback |
| Sham neurofeedback | Sham comparator | Receiving artificially generated feedback signals. Receives: Behavioral: Sham neurofeedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional connectivity change between precuneus and right temporoparietal junction (rTPJ)
Functional connectivity between precuneus and rTPJ will be calculated and evaluated using fMRI BOLD percent signal change.
Measured: Through study completion (average: 2 weeks)
Changes in Brooding subscale of Ruminative Responses Scale (RRS) scores
The RRS Brooding subscale is a self-report scale to measure brooding ruminative responses. A higher score indicates higher brooding ruminative responses with a maximum score of 20 and a minimum score of 5.
Measured: Through study completion (average: 2 weeks)
Secondary outcomes (4)
Changes in Depression subscale of Ruminative Responses Scale (RRS) scores
The RRS Depression subscale is a self-report scale to measure depressive ruminative responses. A higher score indicates higher ruminative responses with a maximum score of 48 and a minimum score of 12.
Measured: Through study completion (average: 2 weeks)
Changes in Reflection subscale of Ruminative Responses Scale (RRS) scores
The RRS Reflection subscale is a self-report scale to measure reflective ruminative responses. A higher score indicates higher ruminative responses with a maximum score of 20 and a minimum score of 5.
Measured: Through study completion (average: 2 weeks)
Changes in sum of Brooding and Depression subscales of Ruminative Responses Scale (RRS) scores
The RRS Brooding and Depression subscales are a self-report scale to measure brooding and depressive ruminative responses. A higher score indicates higher ruminative responses with a maximum score of 68 and a minimum score of 17.
Measured: Through study completion (average: 2 weeks)
Changes in total score of Ruminative Responses Scale (RRS) scores
The RRS is a self-report scale to measure ruminative responses. A higher score indicates higher ruminative responses with a maximum score of 88 and a minimum score of 22.
Measured: Through study completion (average: 2 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2021
- Study start1 Mar 2021
- Primary completion31 Mar 2022
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomly assigned to a cognitive process-based real-time fMRI neurofeedback (CNF) or a sham condition.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laureate Institute for Brain Research, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Salvador Guinjoan, MD, PhD, Principal investigator, Laureate Institute for Brain Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04941066
- Sponsor's protocol ID
- 2021-002
- Acronym
- CNF-rumination
- Status last verified
- Jan 2023
- First submitted
- 10 Jun 2021
- Last updated
- 18 Jan 2023
- 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 18 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Process-based Real-time fMRI Neurofeedback in MDD and Rumination
- ClinicalTrials.gov ID
- NCT04941066
- Acronym / sponsor ID
- CNF-rumination / 2021-002
- Conditions
- Depression, Anxiety
- Keywords
- neurofeedback, real-time fMRI, rumination
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Laureate Institute for Brain Research, Inc.University, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 28 Jun 2021 (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 purpose of this study is to assess the feasibility and efficacy of real-time fMRI neurofeedback for rumination.
Detailed description
Neuroimaging MRI techniques for measuring brain structure, tissue composition, and Blood Oxygenation Level Dependent functional Magnetic Resonance imaging (BOLD fMRI) will be used to measure task-dependent and task-independent brain hemodynamic and electrophysiological changes in human subjects with major depressive disorders (MDD).
After being informed about the study and potential risks, all participants giving written informed consent will undergo one session of the cognitive process-based fMRI neurofeedback (CNF) targeting the rumination-related brain functional connectivity, and a one-week follow-up. Participants will be randomized in a double-blind manner (participant and investigator) in a 1:1 ratio to Active (receiving feedback from their own brain activity) or Sham (receiving artificially generated feedback).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are randomly assigned to a cognitive process-based real-time fMRI neurofeedback (CNF) or a sham condition.
| Arm | Type | Receives |
|---|---|---|
| Active neurofeedback | Experimental | Behavioral: Active neurofeedbackReceiving feedback signals from the rumination-related brain functional connectivity. |
| Sham neurofeedback | Sham comparator | Behavioral: Sham neurofeedbackReceiving artificially generated feedback signals. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Good general health
- DSM-5 diagnosis of major depressive disorder (MDD)
Key exclusion criteria (16 listed)
- Pregnancy
- Moderate to severe traumatic brain injury (>30 min. loss of consciousness or >24 hours posttraumatic amnesia) or other neurocognitive disorder with evidence of neurological deficits.
- Presence of co-morbid medical conditions not limited to but including cardiovascular (e.g., history of acute coronary event, stroke) and neurological diseases (e.g., Parkinson's disease), as well as pain disorders.
- Presence of an uncontrolled medical condition that is deemed by the investigators to interfere with the proposed study procedures, or to put the study participant at undue risk.
- Current severe suicidal ideation or attempt within the past 12 months.
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 |
|---|---|---|
| Active neurofeedbackThe session will be done on an individual basis. The active group will receive neurofeedback training from the rumination-related brain functional connectivity. | Behavioural | Active neurofeedback |
| Sham neurofeedbackThe session will be done on an individual basis. The sham group will receive neurofeedback training from an artificially generated random feedback signal. | Behavioural | Sham neurofeedback |
Primary outcome
Functional connectivity change between precuneus and right temporoparietal junction (rTPJ)
Time frame: Through study completion (average: 2 weeks)
Functional connectivity between precuneus and rTPJ will be calculated and evaluated using fMRI BOLD percent signal change.
Changes in Brooding subscale of Ruminative Responses Scale (RRS) scores
Time frame: Through study completion (average: 2 weeks)
The RRS Brooding subscale is a self-report scale to measure brooding ruminative responses. A higher score indicates higher brooding ruminative responses with a maximum score of 20 and a minimum score of 5.
4 secondary outcomes
Changes in Depression subscale of Ruminative Responses Scale (RRS) scores
Time frame: Through study completion (average: 2 weeks)
Changes in Reflection subscale of Ruminative Responses Scale (RRS) scores
Time frame: Through study completion (average: 2 weeks)
Changes in sum of Brooding and Depression subscales of Ruminative Responses Scale (RRS) scores
Time frame: Through study completion (average: 2 weeks)
Changes in total score of Ruminative Responses Scale (RRS) scores
Time frame: Through study completion (average: 2 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2023.
- 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.
Salvador Guinjoan, MD, PhD principal investigator
Laureate Institute for Brain Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active neurofeedback in people with Depression and Anxiety, run by Laureate Institute for Brain Research, Inc. at 1 site in United States.
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 16 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: finished, as of the sponsor's last update on 18 Jan 2023. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional connectivity change between precuneus and right temporoparietal junction (rTPJ) (time frame: Through study completion (average: 2 weeks)). The study lists 2 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 18 Jan 2023.