NCT03257982

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2018

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

August 16, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 22, 2017

Completed
5 months until next milestone

Study Start

First participant enrolled

January 25, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 14, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 14, 2019

Completed
Last Updated

January 19, 2021

Status Verified

January 1, 2021

Enrollment Period

1.1 years

First QC Date

August 16, 2017

Last Update Submit

January 15, 2021

Conditions

Spinal Cord Injuries

Keywords

Brain-computer interfaceFunctional electrical stimulation

Outcome Measures

Primary Outcomes (1)

  • Successful training for operation of BCI-FES system

    Number of times patients/caregivers successfully operate BCI-FES system within 30 min

    2 months

Secondary Outcomes (7)

  • System reliability

    2 months

  • Time taken to use system

    2 months

  • NASA task load index

    2 months

  • Psychological Effect of Assistive Devices

    2 months

  • Quebec User Evaluation of Satisfaction with Assistive Technology

    2 months

  • +2 more secondary outcomes

Study Arms (1)

BCI-FES hand therapy

EXPERIMENTAL

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

Procedure: BCI-FES hand therapy

Interventions

BCI-FES hand therapyPROCEDURE

BCI-FES rehabilitation therapy of the upper limb

BCI-FES hand therapy

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)
  • +1 more criteria

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Queen Elizabeth National Spinal Injuries Unit

Glasgow, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 33632262DERIVED

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Aleksandra Vuckovic, BEng MSc PhD

    University of Glasgow

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

August 16, 2017

First Posted

August 22, 2017

Study Start

January 25, 2018

Primary Completion

March 14, 2019

Study Completion

March 14, 2019

Last Updated

January 19, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)