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Patient Self-managed BCI-FES

Primary Purpose

Spinal Cord Injuries

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
BCI-FES hand therapy
Sponsored by
NHS Greater Glasgow and Clyde
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Spinal Cord Injuries focused on measuring Brain-computer interface, Functional electrical stimulation

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Patients

  • being within a year post-injury
  • has a caregiver willing to commit their time to the study
  • normal or corrected to normal vision
  • no history of brain disease or injury
  • incomplete injury at level C2 to C7
  • minimum computer literacy
  • understands spoken and written English

Occupational therapists

  • already has experience in providing occupational therapy to spinal cord injured people
  • familiar with using FES on patients

Caregivers

  • able and willing to commit time to the study
  • minimum computer literacy
  • possess mobile phone with a camera or are allowed to use patient's mobile phone with a camera for taking photos of the experimental setup (to remind themselves)
  • understands spoken and written English

Exclusion Criteria:

Patients

  • presence of neurological problem which may distort brain signal recording (e.g. epilepsy, Parkinson's disease, multiple sclerosis)
  • presence of cognitive impairments which would prevent patients or caregivers from understanding the task
  • inability to sit for 2 hours
  • general poor health due to secondary consequences of injury
  • any condition that would be contraindicative of using FES (pacemakers, sensitive skin/sores over areas where electrodes should be applied, pregnancy)

Occupational therapists

  • unable to commit sufficient time to the study
  • cannot learn to setup BCI-FES within 30 min within 4 hourly training sessions

Caregivers

  • cannot be present for all five therapy sessions

Sites / Locations

  • Queen Elizabeth National Spinal Injuries Unit

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

BCI-FES hand therapy

Arm Description

BCI-FES hand therapy sessions (set up and use of system)

Outcomes

Primary Outcome Measures

Successful training for operation of BCI-FES system
Number of times patients/caregivers successfully operate BCI-FES system within 30 min

Secondary Outcome Measures

System reliability
Number of times patients manage to activate the BCI-FES system
Time taken to use system
Average time required to accomplish BCI-FES therapy (excluding setup time)
NASA task load index
Score from National Aeronautics and Space Administration (NASA) Task Load Index questionnaire
Psychological Effect of Assistive Devices
Score of Psychological Effect of Assistive Devices questionnaire
Quebec User Evaluation of Satisfaction with Assistive Technology
Score of Quebec User Evaluation of Satisfaction with Assistive Technology questionnaire
Grip strength
Change in grip strength
Hand range of motion
Change in hand range of motion

Full Information

First Posted
August 16, 2017
Last Updated
January 15, 2021
Sponsor
NHS Greater Glasgow and Clyde
Collaborators
University of Glasgow
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1. Study Identification

Unique Protocol Identification Number
NCT03257982
Brief Title
Patient Self-managed BCI-FES
Official Title
A Feasibility Study of Patient Self-Managed Brain-computer Interface Functional Electrical Stimulation (BCI-FES) Hand Therapy for Spinal Cord Injured Patients
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
January 25, 2018 (Actual)
Primary Completion Date
March 14, 2019 (Actual)
Study Completion Date
March 14, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NHS Greater Glasgow and Clyde
Collaborators
University of Glasgow

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study aims to assess the feasibility of therapist-caregiver-patient training to use BCI and FES technology with a view to the inexpensive equipment eventually being used for home use by tetraplegic patients as a continuing rehabilitation method for sub-acute patients discharged from hospital.
Detailed Description
Spinal Cord Injury (SCI) affects a person's ability to move and feel sensation in the body. People with injury around the neck, suffer from tetraplegia, which affects function of both upper and lower limbs. Although these patients often have a caregiver, their main priority is to regain some upper limb function to increase independence. About half of patients with tetraplegia have an incomplete injury, i.e. have some sensation and control of muscles preserved. Natural recovery takes about a year and is typically accompanied by intense physical therapy while patients are in a hospital. Patients spend on average 4 months in hospital and, once they go home, there are very limited options for further therapy, in particular those living in rural areas. This study will test the feasibility of patient and caregiver self-managed hand therapy based on the combination of brain computer interface (BCI) and functional electrical stimulation (FES). BCI is a system which consists of an electroencephalographic device (EEG), a computer and software that can analyse EEG while it is being recorded. To ensure that the knowledge stays within hospital, occupational therapists will first be trained who will then train patients and caregivers. The BCI-FES therapy is based on a previous clinical study with hospitalised patients, in which a researcher administered the therapy. In this study, a portable BCI-FES system will be used with an inexpensive consumer BCI, which is designed for non-professionals. The primary objective is to assess whether it is feasible for caregivers and patients to learn to operate the portable BCI-FES system on their own within 5 training sessions. The secondary objectives are to collect feedback from patients and therapists of their views via semi-structured interviews and questionnaires; to assess how stable the system parameters (EEG parameters, electrode location, FES stimulation parameters)are over time; to assess whether there is any functional and neurological recovery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries
Keywords
Brain-computer interface, Functional electrical stimulation

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BCI-FES hand therapy
Arm Type
Experimental
Arm Description
BCI-FES hand therapy sessions (set up and use of system)
Intervention Type
Procedure
Intervention Name(s)
BCI-FES hand therapy
Intervention Description
BCI-FES rehabilitation therapy of the upper limb
Primary Outcome Measure Information:
Title
Successful training for operation of BCI-FES system
Description
Number of times patients/caregivers successfully operate BCI-FES system within 30 min
Time Frame
2 months
Secondary Outcome Measure Information:
Title
System reliability
Description
Number of times patients manage to activate the BCI-FES system
Time Frame
2 months
Title
Time taken to use system
Description
Average time required to accomplish BCI-FES therapy (excluding setup time)
Time Frame
2 months
Title
NASA task load index
Description
Score from National Aeronautics and Space Administration (NASA) Task Load Index questionnaire
Time Frame
2 months
Title
Psychological Effect of Assistive Devices
Description
Score of Psychological Effect of Assistive Devices questionnaire
Time Frame
2 months
Title
Quebec User Evaluation of Satisfaction with Assistive Technology
Description
Score of Quebec User Evaluation of Satisfaction with Assistive Technology questionnaire
Time Frame
2 months
Title
Grip strength
Description
Change in grip strength
Time Frame
Baseline and 2 months
Title
Hand range of motion
Description
Change in hand range of motion
Time Frame
Baseline and 2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients being within a year post-injury has a caregiver willing to commit their time to the study normal or corrected to normal vision no history of brain disease or injury incomplete injury at level C2 to C7 minimum computer literacy understands spoken and written English Occupational therapists already has experience in providing occupational therapy to spinal cord injured people familiar with using FES on patients Caregivers able and willing to commit time to the study minimum computer literacy possess mobile phone with a camera or are allowed to use patient's mobile phone with a camera for taking photos of the experimental setup (to remind themselves) understands spoken and written English Exclusion Criteria: Patients presence of neurological problem which may distort brain signal recording (e.g. epilepsy, Parkinson's disease, multiple sclerosis) presence of cognitive impairments which would prevent patients or caregivers from understanding the task inability to sit for 2 hours general poor health due to secondary consequences of injury any condition that would be contraindicative of using FES (pacemakers, sensitive skin/sores over areas where electrodes should be applied, pregnancy) Occupational therapists unable to commit sufficient time to the study cannot learn to setup BCI-FES within 30 min within 4 hourly training sessions Caregivers cannot be present for all five therapy sessions
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aleksandra Vuckovic, BEng MSc PhD
Organizational Affiliation
University of Glasgow
Official's Role
Study Director
Facility Information:
Facility Name
Queen Elizabeth National Spinal Injuries Unit
City
Glasgow
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33632262
Citation
Zulauf-Czaja A, Al-Taleb MKH, Purcell M, Petric-Gray N, Cloughley J, Vuckovic A. On the way home: a BCI-FES hand therapy self-managed by sub-acute SCI participants and their caregivers: a usability study. J Neuroeng Rehabil. 2021 Feb 25;18(1):44. doi: 10.1186/s12984-021-00838-y.
Results Reference
derived

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Patient Self-managed BCI-FES

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