Tele BCI-FES for Upper -Limb Stoke Rehabilitation

NCT ID: NCT05215522

Last Updated: 2023-05-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-15
• Study Completion Date: 2022-12-30

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.

Detailed Description

Movements of different parts of the body, including the arm, start when the brain produces specific electrical signals. Sometimes after a stroke, even though the person intends to move the arm, the arm will not move or will only move partly. The brain continues to produce electrical signals after stroke, but when the signals are weak the arm does not move. Brain-computer interface (BCI), is a method of utilising the brain signals to produce useful outputs via computers. One type of BCI is BCI Functional Electrical Stimulus (BCI-FES) which is a device that can detect these brain signals produced during the intention to move the weak arm after a stroke. It then uses these signals to trigger an electrical stimulator. The electrical stimulator then stimulates the muscles in the weak arm to produce the desired arm movement. Recent studies show that rehabilitation using this device has given better results when compared with conventional rehabilitation approaches. However, the BCI-FES devices currently available are bulky and participants need to come to the hospital or laboratory to receive the treatment. Our project aims to develop a BCI-FES device, called Tele BCI-FES that can be used at stroke participant's home. The investigators are using techniques like machine learning to make the Tele BCI-FES quick and simple to set up, easy to use and effective. This study aims to investigate if the proposed Tele BCI-FES device is a feasible and acceptable intervention for post-stroke rehabilitation.

Conditions

Stroke

Study Design

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

Study Groups

The BCI-FES Intervention

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

Group Type: EXPERIMENTAL

The BCI-FES Intervention

Intervention Type: DEVICE

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.

Interventions

The BCI-FES Intervention

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1) 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.

Exclusion Criteria

1. Cognitive impairment that would interfere with their ability to comply with the experimental protocol or provide informed consent;

2. Dermatological, rheumatologic or orthopaedic illnesses of the affected arm interfering with movement of the elbow;

3. 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

4. Inability to perform the baseline assessments;

5. Severe tactile hypersensitivity;

6. Participation in other, upper limb rehabilitation studies

7. Within 12 weeks of receiving Botulinum toxin injections;

8. History of epilepsy

9. Pace maker or any other implanted devices

10. Pregnancy

11. Severe dystonia/spasm

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

Sponsors

Sheffield Teaching Hospitals NHS Foundation Trust

OTHER

Sponsor Role: collaborator

Medical Research Council

OTHER_GOV

Sponsor Role: collaborator

University of Sheffield

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mahnaz Arvaneh, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Sheffield

Locations

Sheffield Teaching Hospitals

Sheffield, South Yorkshire, United Kingdom

Countries

United Kingdom

References

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.

Reference Type: DERIVED

PMID: 40269846 (View on PubMed)

Related Links

https://teleregain.com/

A website introducing our technology, and our team

Other Identifiers

USheffield1

Identifier Type: -

Identifier Source: org_study_id