Spinal Cord InjuriestcSCSNCT07140354
Regain of Arm and Hand Movements in Cervical Spinal Stimulation
A study testing cervical transcutaneous spinal cord stimulation in people with Spinal Cord Injuries, run by Institut Guttmann at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- cervical transcutaneous spinal cord stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2020to 8 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Regain of Arm and Hand Movements in Cervical Spinal Cord Injury Patients by Means of Spinal Transcutaneous Electrical Neuromodulation Assisted With an Arm Exoskeleton
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.
Read more
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.
Read the detailed description
Patient selection criteria: The study will consist of two populations of patients: Population A will include a total of 10-15 patients with an incomplete cervical lesion (ASIA C and D), and a population B, with 8-15 patients with a complete motor cervical injury (ASIA A and B). Patients from both populations will have ages between 18 and 60 years, with a level of injury between C5 and T1 and with more than 12 months of evolution since the onset of the injury.
Experimental design:
Selected patients from both populations (A and B) will be included in one of the following groups: Group 1: Patients will receive conventional sensory-motor rehabilitation regimen of the upper limb concomitant; Group 2. Patients will receive conventional rehabilitation concomitant with transcutaneous electrical stimulation. Group 3: Patients will have exo-skeleton driven arm rehabilitation concomitant with transcutaneous electrical stimulation. Each session will last 40 minutes and will be done daily during the 6 weeks of evaluation.
Cervical transcutaneous stimulation protocol: Transcutaneous electrical stimulation will be applied by an external set of electrodes, which will be placed on the skin in the midline between the spinous processes of C6 and C8. Two rectangular plates (5.0 x 10.2 cm2) are placed on the skin of the shoulder blades and act as anodes. The electrical stimulation consist of monopolar pulse trains of 1 millisecond duration, released at a frequency of 10 kHz and at an intensity ranging from 80 to 180 mA. Each pulse train is presented at a frequency of 100Hz (ref 8). The stimulation intensity will be adjusted to 90% of the threshold to evoke contractions of the muscles. Rehabilitation of the upper limb. Conventional rehabilitation consists in voluntary, or assisted by a physical therapist, to manually articulate the upper extremities. Patients will perform motor and voluntary rehabilitation of the arms and hands to manipulate objects, performing exercises of grip, endurance and dexterity (ref 9) Robotic upper limb rehabilitation program.
By means of custom-made robotic exo-skeleton patients will move a joystick by a board, following a pattern presented on a television screen. The robot has a sensory feed back system, by which the regain of voluntary movements by the patients will decrease the force exerted by the exo-skeleton to move the arm. Patients will be included in the same number and length of sessions as the conventional rehabilitation regime. Neurological and functional evaluation. To evaluate the effectiveness of the intervention, prior to the initiation of rehabilitation, and once a month until the end of the study, a series of neurological, functional and daily life activities (ref 10) will be performed to evaluate the Effects of spinal stimulation on the motor control of the arms and hands. In addition, prior to the start and the end of each program, motor evoked potentials will be evaluated from the motor cortex and the monoand poly-synaptic reflexes evoked after peripheral nerve stimulation, in order to evaluate the acute and long-term changes in The cortico-medullary and own-medullary connectivity induced by the electrical stimulation.
Data analysis. Each patient will have previous and post-stimulation data. We will evaluate t-test between the different conditions, for each neurological and functional variable evaluated.
- Conditions
- Spinal Cord Injuries
- Being tested
- cervical transcutaneous spinal cord stimulation
- Keywords
- spinal cord injuries, cervical neuromodulation
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cervical transcutaneous spinal cord stimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Device: cervical transcutaneous spinal cord stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 40-50MIN
Secondary outcomes (3)
UEMS
The Upper Extremity Motor Score (UEMS) is a component of the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) used to assess motor function in the upper limbs. It is calculated by testing five key muscle groups on each side (C5-T1), with scores ranging from 0 (total paralysis) to 5 (normal strength), for a maximum of 25 per side and 50 in total.
Measured: 15-20min
Spirometry for respiratory function
Spirometry is a standardized pulmonary function test used to assess respiratory function by measuring airflow and lung volumes during forced breathing maneuvers. Key parameters include Forced Vital Capacity (FVC), Forced Expiratory Volume in 1 second (FEV₁), and the FEV₁/FVC ratio, which provide information on restrictive and obstructive ventilatory patterns.
Measured: 20-30min
MIP and MEP
ChatGPT Plus
Maximal Inspiratory Pressure (MIP) and Maximal Expiratory Pressure (MEP) are non-invasive measures of respiratory muscle strength.
Measured: 20-30min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2025
- Study start1 Sep 2020
- Primary completion1 Mar 2024
- Study completion8 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Guttmann
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joan Vidal, Institut Guttmann
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07140354
- Sponsor's protocol ID
- 235/C/2017
- Acronym
- tcSCS
- Status last verified
- Aug 2025
- First submitted
- 18 Aug 2025
- Last updated
- 24 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regain of Arm and Hand Movements in Cervical Spinal Cord Injury Patients by Means of Spinal Transcutaneous Electrical Neuromodulation Assisted With an Arm Exoskeleton
- ClinicalTrials.gov ID
- NCT07140354
- Acronym / sponsor ID
- tcSCS / 235/C/2017
- Conditions
- Spinal Cord Injuries
- Keywords
- spinal cord injuries, cervical neuromodulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Institut GuttmannUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 8 Sep 2024 (actual)
- First posted
- 24 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Patient selection criteria: The study will consist of two populations of patients: Population A will include a total of 10-15 patients with an incomplete cervical lesion (ASIA C and D), and a population B, with 8-15 patients with a complete motor cervical injury (ASIA A and B). Patients from both populations will have ages between 18 and 60 years, with a level of injury between C5 and T1 and with more than 12 months of evolution since the onset of the injury.
Experimental design:
Selected patients from both populations (A and B) will be included in one of the following groups: Group 1: Patients will receive conventional sensory-motor rehabilitation regimen of the upper limb concomitant; Group 2. Patients will receive conventional rehabilitation concomitant with transcutaneous electrical stimulation. Group 3: Patients will have exo-skeleton driven arm rehabilitation concomitant with transcutaneous electrical stimulation. Each session will last 40 minutes and will be done daily during the 6 weeks of evaluation.
Cervical transcutaneous stimulation protocol: Transcutaneous electrical stimulation will be applied by an external set of electrodes, which will be placed on the skin in the midline between the spinous processes of C6 and C8. Two rectangular plates (5.0 x 10.2 cm2) are placed on the skin of the shoulder blades and act as anodes. The electrical stimulation consist of monopolar pulse trains of 1 millisecond duration, released at a frequency of 10 kHz and at an intensity ranging from 80 to 180 mA. Each pulse train is presented at a frequency of 100Hz (ref 8). The stimulation intensity will be adjusted to 90% of the threshold to evoke contractions of the muscles. Rehabilitation of the upper limb. Conventional rehabilitation consists in voluntary, or assisted by a physical therapist, to manually articulate the upper extremities. Patients will perform motor and voluntary rehabilitation of the arms and hands to manipulate objects, performing exercises of grip, endurance and dexterity (ref 9) Robotic upper limb rehabilitation program.
By means of custom-made robotic exo-skeleton patients will move a joystick by a board, following a pattern presented on a television screen. The robot has a sensory feed back system, by which the regain of voluntary movements by the patients will decrease the force exerted by the exo-skeleton to move the arm. Patients will be included in the same number and length of sessions as the conventional rehabilitation regime. Neurological and functional evaluation. To evaluate the effectiveness of the intervention, prior to the initiation of rehabilitation, and once a month until the end of the study, a series of neurological, functional and daily life activities (ref 10) will be performed to evaluate the Effects of spinal stimulation on the motor control of the arms and hands. In addition, prior to the start and the end of each program, motor evoked potentials will be evaluated from the motor cortex and the monoand poly-synaptic reflexes evoked after peripheral nerve stimulation, in order to evaluate the acute and long-term changes in The cortico-medullary and own-medullary connectivity induced by the electrical stimulation.
Data analysis. Each patient will have previous and post-stimulation data. We will evaluate t-test between the different conditions, for each neurological and functional variable evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tcSCS group | Experimental | Device: cervical transcutaneous spinal cord stimulationThe SCI individuals will receive transcutaneous Spinal Cord Stimulation (tcSCS) at the cervical level during upper extremity Ocupational therapy including ARMEO robotic therapy |
| control group | Placebo comparator | Device: cervical transcutaneous spinal cord stimulationIn the control group the SCI individuals will realize their routine ocupational therapy including ARMEO robotic therapywithout tSCS |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cervical transcutaneous spinal cord stimulationCervical 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. | Device | control group, tcSCS group |
Primary outcome
GRASSP
Time frame: 2-3HRS
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.
MVC of upper extremity
Time frame: 40-50MIN
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.
3 secondary outcomes
UEMS
Time frame: 15-20min
Spirometry for respiratory function
Time frame: 20-30min
MIP and MEP
Time frame: 20-30min
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2025.
- Individual participant dataSharing planned: No
Related trials for Spinal Cord Injuries
Recruiting
MyHand-SCI: An Active Hand Orthosis for Spinal Cord Injury
Spinal Cord Injuries, Tetraplegia
Recruiting
Clinical Outcome Assessment for AT & BCI
Spinal Cord Injury, ALS (Amyotrophic Lateral Sclerosis)
Recruiting
Transcutaneous Spinal Cord Stimulation Combined With 4-Aminopyridine and Intensive Rehabilitation in SCI
Spinal Cord Injuries
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
RecruitingPhase 3
A Trial Investigating the Efficacy and Safety of NVG-291 in Subjects With Chronic Spinal Cord Injury
Chronic Spinal Cord Injury
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cervical transcutaneous spinal cord stimulation in people with Spinal Cord Injuries, run by Institut Guttmann at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GRASSP (time frame: 2-3HRS). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2025.