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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorKing's College London

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • 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

Treatment groups

24 Participants
are divided into 1 treatment group
Group A: Brain-computer interface rehabilitationExperimental treatment 1 intervention

Trial outcomes

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)

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: