NCT05215522

Brief Summary

The study aims to identify whether stroke survivors can intentionally modulate their brain signals for controlling an FES device to produce arm movements for home based rehabilitation. The study also assess the participants acceptability of this new home-based rehabilitation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Jun 2022

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 13, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 31, 2022

Completed
5 months until next milestone

Study Start

First participant enrolled

June 15, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

May 15, 2023

Status Verified

December 1, 2021

Enrollment Period

6 months

First QC Date

December 13, 2021

Last Update Submit

May 12, 2023

Conditions

Stroke

Keywords

Brain-computer interfacefunctional electrical stimulationTele-rehabilitationstroke rehabilitation

Outcome Measures

Primary Outcomes (3)

  • Evaluate the feasibility of the proposed system through the ability of participants to control the Tele BCI-FES

    To evaluate whether the participants can effectively control FES using the developed remote BCI system (Success: the BCI accuracy of more than 70% in at least 7 out of 9 sessions).

    within 10 minutes after experimental session

  • Evaluate the usability and acceptability of the proposed system based on the number of participants completing each TeleBCI-FES intervention session

    Number of participants completing each TeleBCI-FES intervention session (Success: 7 participants completed 8 or more of 12 TeleBCI-FES sessions)

    through study completion, an average of 5 weeks

  • Recruitment rate

    To measure the acceptability of the proposed rehabilitation

    Pre-intervention

Secondary Outcomes (8)

  • Fugl-Meyer Assessment

    Pre-intervention and up to 5 weeks

  • Action Research Arm Test

    Pre-intervention and up to 5 weeks

  • Modified Ashworth Scale

    Pre-intervention and up to 5 weeks

  • Medical Research Council grading

    Pre-intervention and up to 5 weeks

  • Leeds Arm Spasticity Scale-reference

    Baseline and up to 5 weeks

  • +3 more secondary outcomes

Other Outcomes (1)

  • Interviews

    within 10 minutes after experimental session

Study Arms (1)

The BCI-FES Intervention

EXPERIMENTAL

The BCI-FES device will be used by all participants.

Device: The BCI-FES Intervention

Interventions

The BCI-FES InterventionDEVICE

To evaluate whether the participant can effectively control FES using the developed remote BCI system. Thus, participants will receive a three-week BCI-FES intervention at their home, including three sessions of intervention per week. Each session will last around 60 minutes, including 10 minutes of preparation, 40 minutes of intervention and 10 minutes interview on the user's experience with the device and any experienced side effects, if any.

The BCI-FES Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \) Age 18 and above.
  • (2) Experienced an ischaemic or haemorrhagic stroke more than 6 months ago.
  • (3) Arm weakness interfering with activities of daily living.
  • (4) Fugl-Meyer score of upper limb\<45.
  • (5) Caregiver is willing to assist with trial by helping to deliver intervention.
  • (6) Cognitive and language abilities to understand and participate in the study protocol.
  • (7) Can maintain sitting with or without support for 1 hour continuously.
  • (8) Able to give consent and understand instructions.

You may not qualify if:

  • Cognitive impairment that would interfere with their ability to comply with the experimental protocol or provide informed consent;
  • Dermatological, rheumatologic or orthopaedic illnesses of the affected arm interfering with movement of the elbow;
  • Pre-existing severe systemic disorders like cardiovascular disease; active cancer or renal disease; end stage pulmonary or cardiovascular disease; psychiatric illness including severe alcohol or drug abuse
  • Inability to perform the baseline assessments;
  • Severe tactile hypersensitivity;
  • Participation in other, upper limb rehabilitation studies
  • Within 12 weeks of receiving Botulinum toxin injections;
  • History of epilepsy
  • Pace maker or any other implanted devices
  • Pregnancy
  • Severe dystonia/spasm

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheffield Teaching Hospitals

Sheffield, South Yorkshire, S5 7AT, United Kingdom

Location

Related Publications (1)

  • Mansour S, Giles J, Nair KPS, Marshall R, Ali A, Arvaneh M. A clinical trial evaluating feasibility and acceptability of a brain-computer interface for telerehabilitation in patients with stroke. J Neuroeng Rehabil. 2025 Apr 24;22(1):91. doi: 10.1186/s12984-025-01607-x.

    PMID: 40269846DERIVED

Related Links

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Mahnaz Arvaneh, PhD

    University of Sheffield

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 13, 2021

First Posted

January 31, 2022

Study Start

June 15, 2022

Primary Completion

November 30, 2022

Study Completion

December 30, 2022

Last Updated

May 15, 2023

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

The participant's data will be "pseudo-anonymized" and no identifiable information will be maintained with the study data because the participant will be issued a unique study number. Paper copies of consent forms will be kept in locked cupboards at the University of Sheffield's Physiological Signals and Systems lab. Electronic data will be entered and saved immediately on a password-protected University server. After the study is completed, anonymised EEG data and questionnaire data will be preserved for fifteen years at the University of Sheffield archiving facility. The results of this study will be published in peer-reviewed journals. The findings will be presented in BCI and rehabilitation conferences, as well as patient-public involvement meetings. The participants will not be identifiable from any report or publication placed in the public domain.

Locations

GB(1)