Functional Neurological DisorderBRAVE-FNDNCT07006415
Brain-computer Interface Rehabilitation And Virtual Environments in Functional Neurological Disorder (BRAVE-FND)
A study testing Brain-computer interface rehabilitation in people with Functional Neurological Disorder and Conversion Disorder, run by King's College London.
Trial summary
The purpose of this study is to determine whether a course of rehabilitation using a device called a brain-computer interface can change the level of control people feel over bodily movements, in functional neurological disorder. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Functional Neurological Disorder, Conversion Disorder, Functional Neurological Disorders
- What is being tested?
- Brain-computer interface rehabilitation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2025to 31 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- DSM5 diagnosis of motor FND (limb weakness, gait disorder, tremor or dystonia) from a neurologist and/or neuropsychiatrist.
- Moderate or severe symptoms (≥4 on Clinical Global Impression Severity (CGI-S) scale).
- Able to tolerate VR and BCI use.
- Age 18 - 60 years.
- English speaking.
Who cannot join
- Current diagnosis of epilepsy, severe depression, bipolar disorder, psychotic disorder, personality disorder, or drug/alcohol dependence/harmful use (defined as meeting DSM-5 criteria) (Mini International Neuropsychiatric Interview [MINI] 7.0). Positive diagnoses on the MINI will be subject to confirmation at clinical interview by a psychiatrist.
- Current diagnosis of epilepsy, autistic spectrum disorder, dementia, learning disability (defined as meeting DSM-5 criteria) based on clinical interview by a psychiatrist.
- A pacemaker, implantable cardioverter-defibrillator or any other implanted electronic or metallic device.
- Current pregnancy.
- Non-registration with a GP or failure to consent to sharing of the GP summary care record and any psychiatric assessments held.
- Those enrolled in another clinical or research study.
- Those unable to give informed consent.
About this study
The purpose of this study is to determine whether a course of rehabilitation using a device called a brain-computer interface can change the level of control people feel over bodily movements, in functional neurological disorder.
- Conditions
- Functional Neurological Disorder, Conversion Disorder, Functional Neurological Disorders, Conversion Disorder With Weakness/Paralysis
- Being tested
- Brain-computer interface rehabilitation
- Keywords
- brain-computer interface, rehabilitation
- Medical subject headings
- Conversion Disorder, Paralysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain-computer interface rehabilitationDevice
10 sessions of motor imagery rehearsal rehabilitation using a brain-computer interface with functional electrical stimulation and a virtual avatar
| Study group | Role | What they receive |
|---|---|---|
| Brain-computer interface rehabilitation | Experimental | Brain-computer interface rehabilitation Receives: Device: Brain-computer interface rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in sense of agency over limb movements
Seven point Likert scale for explicit self-reported sense of agency over limb movements
Measured: Baseline (same day as rehabilitation session 1, immediately before session) and after course of 10 sessions of brain-computer interface rehabilitation (same day as rehabilitation session 10, immediately after session) (intra-subject)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2025
- Study start1 Oct 2025 (estimated)
- Primary completion31 Jan 2028 (estimated)
- Study completion31 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional Neurological 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07006415
- Sponsor's protocol ID
- 349392
- Other IDs
- TBC
- Acronym
- BRAVE-FND
- Status last verified
- May 2025
- First submitted
- 19 May 2025
- Last updated
- 5 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain-computer Interface Rehabilitation And Virtual Environments in Functional Neurological Disorder (BRAVE-FND)
- ClinicalTrials.gov ID
- NCT07006415
- Acronym / sponsor ID
- BRAVE-FND / 349392
- Conditions
- Functional Neurological Disorder, Conversion Disorder, Functional Neurological Disorders, Conversion Disorder With Weakness/Paralysis
- Keywords
- brain-computer interface, rehabilitation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 31 Jan 2028 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 5 Jun 2025 (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 determine whether a course of rehabilitation using a device called a brain-computer interface can change the level of control people feel over bodily movements, in functional neurological disorder.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Brain-computer interface rehabilitation | Experimental | Device: Brain-computer interface rehabilitationBrain-computer interface rehabilitation |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- DSM5 diagnosis of motor FND (limb weakness, gait disorder, tremor or dystonia) from a neurologist and/or neuropsychiatrist.
- Moderate or severe symptoms (≥4 on Clinical Global Impression Severity (CGI-S) scale).
- Able to tolerate VR and BCI use.
- Age 18 - 60 years.
- English speaking.
Key exclusion criteria (7 listed)
- Current diagnosis of epilepsy, severe depression, bipolar disorder, psychotic disorder, personality disorder, or drug/alcohol dependence/harmful use (defined as meeting DSM-5 criteria) (Mini International Neuropsychiatric Interview [MINI] 7.0). Positive diagnoses on the MINI will be subject to confirmation at clinical interview by a psychiatrist.
- Current diagnosis of epilepsy, autistic spectrum disorder, dementia, learning disability (defined as meeting DSM-5 criteria) based on clinical interview by a psychiatrist.
- A pacemaker, implantable cardioverter-defibrillator or any other implanted electronic or metallic device.
- Current pregnancy.
- Non-registration with a GP or failure to consent to sharing of the GP summary care record and any psychiatric assessments held.
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 |
|---|---|---|
| Brain-computer interface rehabilitation10 sessions of motor imagery rehearsal rehabilitation using a brain-computer interface with functional electrical stimulation and a virtual avatar | Device | Brain-computer interface rehabilitation |
Primary outcome
Change in sense of agency over limb movements
Time frame: Baseline (same day as rehabilitation session 1, immediately before session) and after course of 10 sessions of brain-computer interface rehabilitation (same day as rehabilitation session 10, immediately after session) (intra-subject)
Seven point Likert scale for explicit self-reported sense of agency over limb movements
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Brain-computer interface rehabilitation in people with Functional Neurological Disorder and Conversion Disorder, run by King's College London.
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 5 inclusion and 7 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: opening soon, as of the sponsor's last update on 5 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
This study is still under way. Results are not available in the source record yet.
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?
Change in sense of agency over limb movements (time frame: Baseline (same day as rehabilitation session 1, immediately before session) and after course of 10 sessions of brain-computer interface rehabilitation (same day as rehabilitation session 10, immediately after session) (intra-subject)). 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 5 Jun 2025; AzTrials last refreshed its copy on 30 Oct 2026.