NCT01852279

Brief Summary

This study will assess whether functional recovery of the hand muscles in patients with spinal cord injury is enhanced when electrical stimulation of the muscles is delivered actively by means of using the electroencephalography wave patterns arising from the patient imagining moving their hand to operate the stimulator. A control group will obtain the electrical stimulation treatment passively by a therapist operating the machine.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2013

Longer than P75 for not_applicable

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

April 30, 2013

Completed
8 days until next milestone

Study Start

First participant enrolled

May 8, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 13, 2013

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

December 19, 2020

Status Verified

December 1, 2020

Enrollment Period

5.7 years

First QC Date

April 30, 2013

Last Update Submit

December 17, 2020

Conditions

Spinal Cord Injury

Outcome Measures

Primary Outcomes (1)

  • Muscle strength as measured by the Oxford manual test

    Between initial and final assessment after up to 8 weeks of treatment

Secondary Outcomes (7)

  • Changes in patients EEG before and after each treatment session

    between beginning and end of each one hour treatment session

  • Difference in EEG between the treatment and the control group

    Between initial and final assessment after up to 8 weeks of treatment

  • Difference in Somatosensory evoked potential between the treatment and control group

    Between initial and final assessment after up to 8 weeks of treatment

  • Difference in somatosensory evoked potential before and after a treatment session

    Between initial and final assessment after up to 8 weeks of treatment

  • Patient's experience of using BCI-FES

    Between initial and final assessment after up to 8 weeks of treatment

  • +2 more secondary outcomes

Study Arms (2)

Active muscle stimulation

EXPERIMENTAL

Muscle stimulation delivered by Brain Computer Interface

Device: BCI-FES

Passive muscle stimulation

ACTIVE COMPARATOR

FES will be delivered by therapist

Device: Passive muscle stimulation

Interventions

BCI-FESDEVICE

Brain computer Interface delivered Function Electrical Stimulation

Active muscle stimulation
Passive muscle stimulationDEVICE

Functional Electrical stimulation delivered by therapist

Passive muscle stimulation

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • incomplete (ASIA B, C) tetraplegia with injury at level C4-C8
  • aged between 18 and 70 years old
  • a candidate suitable for the conventional therapy

You may not qualify if:

  • Patients must not have presence of any neurological problem that might distort recording standard brain signal during motor imagination (example: brain damage, epilepsy, Parkinson disease and multiple sclerosis)
  • Patients must not have cognitive impairments (hearing, vision and general inability to understand instructions)
  • Patients must not suffer from recurring pressure sore which prevent patient from sitting for at least an hour
  • Patients must not suffer from excessive spasm that would increase with electrical stimulation.

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)

  • Osuagwu BC, Wallace L, Fraser M, Vuckovic A. Rehabilitation of hand in subacute tetraplegic patients based on brain computer interface and functional electrical stimulation: a randomised pilot study. J Neural Eng. 2016 Dec;13(6):065002. doi: 10.1088/1741-2560/13/6/065002. Epub 2016 Oct 14.

    PMID: 27739405DERIVED

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, PhD

    University of Glasgow

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 30, 2013

First Posted

May 13, 2013

Study Start

May 8, 2013

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

December 19, 2020

Record last verified: 2020-12

Locations

GB(1)