ClinicalTrials.gg
Not yet recruitingNCT07006415BRAVE-FNDUpdated Jun 5, 2025

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

An interventional study of Brain-computer interface rehabilitation in Functional Neurological Disorder, Conversion Disorder and Functional Neurological Disorders, sponsored by King's College London. Not yet recruiting. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-06-05.

Sponsored by King's College London · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Not applicable
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

02

Conditions studied

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

Keywords

  • brain-computer interface
  • rehabilitation
03

In context

Conversion Disorder

89 studies on the registry are indexed under Conversion Disorder; 34 are open to participants now.

This study's planned enrollment of 24 is below the median of 38 across 51 interventional studies indexed under Conversion Disorder.

Browse Conversion Disorder studies →

Lead sponsor

King's College London is the lead sponsor of 520 studies on the registry; 126 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Current diagnosis of epilepsy, severe depression, bipolar disorder, psychotic disorder, personality disorder, or drug/alcohol dependence/harmful use (defined as meeting 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 .
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
24 participants (estimated)

Study arms

  • Experimental
    Brain-computer interface rehabilitation

    Brain-computer interface rehabilitation

    Device: Brain-computer interface rehabilitation

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

06

What researchers measure

Primary outcomes

  1. Change in sense of agency over limb movements

    Seven point Likert scale for explicit self-reported 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)

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 5, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07006415
Responsible party
Sponsor
First posted
Jun 5, 2025
Start date
Oct 1, 2025 (estimated)
Primary completion
Jan 31, 2028 (estimated)
Completion
Jan 31, 2028 (estimated)
Last update
Jun 5, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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