Brain-computer Interface Rehabilitation And Virtual Envir... | NCT07006415

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

NCT07006415

Sponsor

King's College London

Status

Not yet recruiting

Last Update Posted

Jun 5, 2025Actual

Enrollment

24Estimated

Phase

Not Applicable

Conditions

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

Interventions

Brain-computer interface rehabilitation

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

ID	Type	Description	Link
TBC	Other Grant/Funding Number	TBC

Status Module

Record Verification Date

May 2025

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2025Estimated

Primary Completion Date

Jan 31, 2028Estimated

Completion Date

Jan 31, 2028Estimated

First Submitted Date

May 19, 2025

First Submission Date that Met QC Criteria

May 27, 2025

First Posted Date

Jun 5, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 27, 2025

Last Update Posted Date

Jun 5, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Brain-computer interface rehabilitation	Experimental	Brain-computer interface rehabilitation	Device: Brain-computer interface rehabilitation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D013001	Somatoform Disorders
D001523	Mental Disorders
D009461	Neurologic Manifestations
D009422	Nervous System Diseases
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D003291	Conversion Disorder
D010243	Paralysis