Tele BCI-FES for Upper -Limb Stoke Rehabilitation

University of Sheffield

Status: Completed

Conditions: Stroke

Treatments: Device: The BCI-FES Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT05215522

USheffield1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 13 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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13 participants in 1 patient group

The BCI-FES Intervention

Experimental group

Description:

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

Treatment:

Device: The BCI-FES Intervention