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

NCT ID: NCT07006415

Last Updated: 2025-06-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-01
• Study Completion Date: 2028-01-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Brain-computer interface rehabilitation

Brain-computer interface rehabilitation

Group Type: EXPERIMENTAL

Brain-computer interface rehabilitation

Intervention Type: DEVICE

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

Interventions

Brain-computer interface rehabilitation

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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

King's College London

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

TBC

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

349392

Identifier Type: -

Identifier Source: org_study_id