Regain of Arm and Hand Movements in Cervical Spinal Stimulation

NCT07140354 | Completed

• 1 other identifier: 235/C/2017
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

We will develop a "bottom to top" approach employing animal models and human testing to determine whether or not non-invasive neuro-modulation of the cervical spinal cord concomitant with upper limb rehabilitation driven by exo-skeletons can facilitate the regain of the arm and hand functional movements in spinal cord injured patients. We hypothesize that that spinal electrical neuro-modulation together with sensory-motor rehabilitation will facilitate the transmission and processing of the motor commands along the residual brain-to-spinal connectome leading to the regain of arm and hand movements. The proposal follows a multi-disciplinary and translational approach; including basic scientists, engineers and clinicians, and is divided in 3 independent but related working packages (WP). WP1: Develop of a selfcontained hybrid robotic system to drive arm and hand movements rehabilitation in spinal cord injured patients. WP2: Implement the exo-skeleton to rehabilitate arm and hand movements concomitant to cervical electrical neuro-modulation in cervical spinal cord inured patients. WP3: In an animal model, using the optimal spinal stimulation parameters, identify the cellular and molecular changes in the brain-to-spinal connectome, which mediates recovery. The results will support the development of the first feasible treatment to improve manual dexterity in cervical spinal cord inured patients, and will present a comprehensive and detailed analysis of the mechanisms underlying the recovery, providing an indispensable guideline for the application of stimulation-based therapy to SCI patients. This proposal is a continuation of a recently awarded grant (2017-2020, funded by "Instituto Carlos III"), intended to obtain the optimal stimulation parameters to effectively neuromodulate the cervical spinal cord and facilitate arm function. The present proposal is the natural step forward, in which we want to explore in depth the mechanisms underpinning recovery, and further strength the rehabilitation intervention with arm exo

• skeleton, which will allow the performance of movements in severely injured patients.

Conditions

Spinal Cord Injuries

Keywords

spinal cord injuries; cervical neuromodulation

Outcome Measures

Primary Outcomes (2)

• GRASSP

  The Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) is a standardized clinical tool designed to evaluate upper limb function in individuals with cervical spinal cord injury. It assesses strength, sensory function, and hand prehension ability to provide a comprehensive measure of hand and arm impairment.

  2-3HRS

• MVC of upper extremity

  Maximum Voluntary Contraction (MVC) of the upper extremity refers to the greatest amount of force that a person can voluntarily generate with a specific muscle or muscle group of the arm or hand during an isometric contraction. It is commonly used as a standardized measure of muscle strength in research and rehabilitation, often recorded with devices such as dynamometers or force transducers.

  40-50MIN

Secondary Outcomes (3)

• UEMS

  15-20min

• Spirometry for respiratory function

  20-30min

• MIP and MEP

  20-30min

Other Outcomes (1)

• Quality of life measured by WhoQol-Bref

  20-30min

Study Arms (2)

tcSCS group

EXPERIMENTAL

The SCI individuals will receive transcutaneous Spinal Cord Stimulation (tcSCS) at the cervical level during upper extremity Ocupational therapy including ARMEO robotic therapy

Device: cervical transcutaneous spinal cord stimulation

control group

PLACEBO COMPARATOR

In the control group the SCI individuals will realize their routine ocupational therapy including ARMEO robotic therapywithout tSCS

Device: cervical transcutaneous spinal cord stimulation

Interventions

cervical transcutaneous spinal cord stimulation DEVICE

Cervical transcutaneous spinal cord stimulation (tSCS) delivers electrical currents over the cervical spinal cord to modulate neural circuits controlling the upper extremities. This approach has been shown to facilitate motor output, improve hand and arm function, and promote neuroplasticity in individuals with cervical spinal cord injury.

control group; tcSCS group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• male or female, more than 18 years old;
• a stable traumatic or no traumatic cervical SCI
• time since SCI: 3-12 months
• AIS A, B, C, and D with but at least ≥ 2 muscles affected in the upper extremities, with a total sum of muscle strength more than 2 points in two muscles (the wrist extension together with abductor pollicis brevis (APB) at least in one side).

You may not qualify if:

• unstable medical condition (cancer, acute infections, etc.)
• dependent on mechanical ventilation
• severe spasticity (≥3 score on the Modified Ashworth scale-MAS)
• contraindication for rehabilitation assisted with a robotic exoskeleton (Armeo®Power)
• peripheral nerve injury
• intolerance of tSCS, peacemakers, electronic implants, or episodes of epilepsy
• participating in another investigation.

Sponsors & Collaborators

• Institut Guttmann: lead

Study Sites (1)

Institut Guttmann

Badalona, Barcelona, 08916, Spain

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 Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Regain of arm and hand movements in cervical spinal cord injury patients by means of spinal electrical neuromodulation assisted with an arm exoskeleton.

Study Record Dates

• First Submitted: August 18, 2025
• First Posted: August 24, 2025
• Study Start: September 1, 2020
• Primary Completion: March 1, 2024
• Study Completion: September 8, 2024
• Last Updated: August 24, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)