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Not yet recruiting NCT07006415

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

No phase Interventional Functional Neurological Disorder Conversion Disorder Functional Neurological Disorders Conversion Disorder With Weakness/Paralysis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Brain-computer interface rehabilitation.
Who it may be relevant to
Registry conditions: Functional Neurological Disorder, Conversion Disorder, Functional Neurological Disorders, Conversion Disorder With Weakness/Paralysis. Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

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

Primary outcome measures

  • Change in 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)]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Basic science

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07006415 · 349392 · TBC

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗