Health TrialsbyHealthPanel

tESCS for Upper Limb Rehab in Spinal Cord Injury

ConditionSpinal Cord Injuries (SCI)
Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorNHS Greater Glasgow and Clyde

About this trial

Regaining hand and arm function is an important step towards regaining independence following high-level spinal cord injury (tetraplegia). The delivery of small electrical pulses over the skin above the spinal cord, called transcutaneous spinal cord stimulation (tESCS), appears to improve the arm and hand function of people who have had tetraplegia for several years when delivered at the same time as upper limb therapy. However, tESCS has not been tested in people who have a new spinal cord injury. It should be straightforward to deliver tESCS during standard upper limb therapy sessions to inpatients receiving primary rehabilitation. The investigators want to test the practical aspects of delivering this intervention and also to compare recovery between a group of people who only receive upper limb therapy and a group who receive upper limb therapy and tESCS. If successful, tESCS could in the future be used as part of regular therapy following an acute spinal cord injury. Benefits could include faster and better recovery, reduced stay in hospital, and reduced NHS costs.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged 18 years or over, both sexes.

At least 6 weeks post-implant (in participants having a surgery for an implant to stabilise the spine).

ISNCSCI upper extremity motor score between 5 and 30 (both arms/hands)

GRASSP-strength score >=15 & <70

Disqualifiers

Unstable cervical spine injury

Needing ventilation assistance during daytime

Any implanted active metallic device without unconfirmed MRI compatibility (in our previous studies, we safely applied tESCS to participants with MRI-compatible devices/implants)

Pregnancy and/or lactation.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Transcutaneous spinal cord stimulation (tESCS) active group

    Device

    Participants in the active arm will receive 60 min of tESCS alongside the conventional occupation therapy, 20 sessions for 4 weeks, 5 times per week

  • Sham transcutaneous spinal cord stimulation (tESCS)

    Device

    The control group will receive only 1 min of tESCS while doing conventional occupational therapy for 60 min. Number of session 20, 4 weeks, 5 times a week

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: InterventionExperimental treatment 1 intervention
Group B: ControlSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Retention

Recruitment and retention

Time frame
From enrollment till the last assesment at 8 weeks
2

Interference

Interference with daily routine

Time frame
From enrolment till the end of intervention at 4 weeks
3

Stimulation

Optimal current stimulation intensity in mA

Time frame
From the first till the last intervention session at 4 weeks
4

Adverse effects

The number of adverse effects

Time frame
from the first till the last intervention session at 4 weeks

Secondary outcomes

1

Hand function

Sensory and motor test Graded and Redefined Assessment of Strength, Sensibility and Prehension (GRASSP), range 0-166 (0 no function, 116 all normal)

Time frame
From the first intervention session till the last assesment at 8 weeks
2

Spinal Cord Independence Measure

Spinal Cord Independence Measure (range 0-100, 100 max independence)

Time frame
From the recruitment till the last assessment at 8 weeks
3

Quality of life basic dataset

International Spinal Cord Injury Data Sets Quality of Life Basic Data Set -Data Form

Time frame
From recruitment till the last assessment at 8 weeks
4

Spasticity

Modified Ashworth Scale range 0-4 (0 no increased tone, 4 very rigid)

Time frame
From the enrolment till the last assesment at 8 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

NHS Greater Glasgow and Clyde

Lead sponsor

University of Glasgow

Collaborator

The Queen Elizabeth Hospital

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: