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

NCT07006415 | Not Yet Recruiting

• 2 other identifiers: 349392TBC
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Keywords

brain-computer interface; rehabilitation

Outcome Measures

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

  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)

Study Arms (1)

Brain-computer interface rehabilitation

EXPERIMENTAL

Brain-computer interface rehabilitation

Device: Brain-computer interface rehabilitation

Interventions

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

Brain-computer interface rehabilitation

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• King's College London: lead

MeSH Terms

Conditions

Conversion Disorder; Paralysis

Condition Hierarchy (Ancestors)

Somatoform Disorders; Mental Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2025
• First Posted: June 5, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): January 31, 2028
• Last Updated: June 5, 2025

Record last verified: 2025-05