TCES for Upper Limb Function in Cervical SCI

NCT05801536 | Completed

• 1 other identifier: NMN007
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

Following a cervical spinal cord injury (cSCI; damage to the spinal cord at the neck) there is catastrophic loss of hand and grip function. This has a devastating effect on quality of life and functional independence. Thus, there is a real need to identify and optimise therapy to aid functional arm and hand recovery. One such therapy is Transcutaneous Electrical Stimulation (tCES). This involves applying sticky pads to the skin and then transmitting a low-level electrical current to the spinal cord. This activates neural circuits, allowing injured nerves to transmit signals to muscles to produce movement while completing upper limb tasks. The purpose of this pilot project is to establish if and how tCES might be used to improve arm and hand control. The investigators will recruit 8 people who have had a cSCI for \>1yr. First, the investigators will invite volunteers to the University for 2 weeks, twice per week, to establish their baseline movement capacity. Then the investigators will allocate the volunteers to one of two groups: group 1 will undertake 4 weeks of upper limb task practice (ULTP) followed by 4 weeks of ULTP+tCES; group 2 will undertake ULTP+tCES for 4 weeks followed by 4 weeks of ULTP. Participants will then complete a week (2 sessions) of post-intervention assessment. The investigators will then invite volunteers and carers to be interviewed about their experiences of being involved in the project. Finally, there will be 2 sessions of follow-up assessment after 3 months. In order to assess if and how ULTP+tCES affects arm and hand control the investigators will measure: movement capacity using standard clinical tests; muscular activity in response to brain/spinal stimulation; how fast and smooth movements are when reaching and grasping objects. The investigators will also examine how the intervention has affected Quality of Life (QoL) and independence (Spinal Cord Independence Measure).

Conditions

Spinal Cord Injuries

Keywords

transcutaneous electrical stimulation; cervical; upper limbs

Outcome Measures

Primary Outcomes (1)

• GRASSP

  Graded and Redefined Assessment of Strength, Sensibility and Prehension test. The primary objective of the study is to measure and compare the changes in hand and arm functions, assessed through the Graded and Redefined Assessment of Strength, Sensibility and Prehension test (GRASSP) tool, occurring over the course of the two interventions (ULTP and ULTP + TCES).

  17 months

Secondary Outcomes (9)

• Kinematics movement time

  17 months

• Kinematics peak velocity

  17 months

• Surface Electromyography (sEMG) amplitude

  17 months

• Surface Electromyography (sEMG) frequency

  17 months

• Spinal-evoked potentials

  17 months

Study Arms (1)

Upper limb task practice with or without cervical transcutaneous electrical stimulation

EXPERIMENTAL

Task specific practice will be combined with cervical transcutaneous electrical stimulation.

Device: SCONE

Interventions

SCONE DEVICE

This is a noninvasive (nonsurgical) electrical neuromodulation device to reactivate and retrain the neurons and neural networks in the spinal cord to improve function after neurological trauma. The device will be used to stimulate the cervical spinal cord as participants practice tasks involving upper limb control.

Upper limb task practice with or without cervical transcutaneous electrical stimulation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cervical (between C3 and C7) spinal cord injury at least 1 year prior to the study.
• Between 18 and 80 years of age.
• Difficulty with hand functions in activities of daily living (e.g. dressing, grooming, feeding)
• Stable medical condition without cardiopulmonary disease or frequent autonomic dysreflexia that would contraindicate participation in upper extremity rehabilitation or testing activities.
• Capable of performing simple cued motor tasks such as reaching and touching or grasping objects.
• Ability to attend 3 sessions of weekly experimental sessions and testing activities over the course of 8 weeks.
• Ability to provide informed consent (either verbally or in writing).
• Ability to read/speak English.

You may not qualify if:

• History of additional neurologic disease, such as stroke, multiple sclerosis, traumatic brain injury, etc.
• Peripheral neuropathy (diabetic polyneuropathy, entrapment neuropathy, etc.).
• Rheumatic diseases (rheumatoid arthritis, systemic lupus erythematosus, etc.).
• Active cancer
• Cardiovascular or pulmonary disease that would prevent full participation in the upper limb practice intervention
• Ongoing medical complications (such as unhealed fracture, contracture, pressure sore, or urinary tract infection or other illnesses) that might interfere with upper extremity rehabilitation or testing activities
• Any condition that would render the patient unable to safely cooperate with the study tests as judged by the screening physician
• Personal or familial history of epilepsy
• Pregnancy
• Botulinum toxin injections in the prior 6 months
• Dependent on ventilation support
• Implanted stimulator (e.g. vagus nerve stimulator, pacemaker, cochlear implant, etc) 0r infusion device (e.g. insulin pump, etc).
• Pregnancy
• Alcohol and/or drug abuse.
• Unable to read and/or comprehend the consent form.

Sponsors & Collaborators

• University of Leeds: lead
• International Spinal Research Trust: collaborator

Study Sites (1)

University of Leeds

Leeds, West Yorkshire, LS2 9JT, United Kingdom

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Sarah Astill, PhD

  University of Leeds

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor in Motor Control

Study Record Dates

• First Submitted: March 16, 2023
• First Posted: April 6, 2023
• Study Start: June 13, 2022
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: June 20, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)