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Brain-computer Interface Rehabilitation And Virtual Environments in Functional Neurological Disorder (BRAVE-FND)

Brain-computer Interface Rehabilitation And Virtual Environments in Functional Neurological Disorder (BRAVE-FND)

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07006415
Acronym
BRAVE-FND
Enrollment
24
Registered
2025-06-05
Start date
2025-10-01
Completion date
2028-01-31
Last updated
2025-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Conversion Disorder, Conversion Disorder With Weakness/Paralysis, Functional Neurological Disorder, Functional Neurological Disorders

Keywords

brain-computer interface, rehabilitation

Brief 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.

Interventions

DEVICEBrain-computer interface rehabilitation

10 sessions of motor imagery rehearsal rehabilitation using a brain-computer interface with functional electrical stimulation and a virtual avatar

Sponsors

King's College London
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Change in sense of agency over limb movementsBaseline (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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026