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NCT Number: NCT07006415

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

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.

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Key information

Conditions

Functional Neurological Disorder Conversion Disorder Conversion Disorder with Weakness/Paralysis Functional Neurological Disorders Mental Disorders Nervous System Diseases Neurologic Manifestations Paralysis Pathological Conditions, Signs and Symptoms Signs and Symptoms Somatoform Disorders

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Brain-computer interface rehabilitation

Device

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

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

King's College London

Other

Registry information

Acronym: BRAVE-FND

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jun 5, 2025
Registry last updated
Jun 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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