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Regain of Arm and Hand Movements in Cervical Spinal Stimulation

NCT07140354 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-08-24

No results posted yet for this study

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

Interventions

DEVICE

cervical transcutaneous spinal cord stimulation

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.

Sponsors & Collaborators

  • Institut Guttmann

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-01
Primary Completion
2024-03-01
Completion
2024-09-08

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07140354 on ClinicalTrials.gov