Spinal Cord InjuryNEUROSTIM-SCINCT07893470
Transcutaneous Spinal Cord Stimulation for Neurorehabilitation After Spinal Cord Injury
A study testing ExaStim® Transcutaneous Spinal Cord Stimulation and Conventional Rehabilitation in people with Spinal Cord Injury, run by Ernesto Losavio at 1 site in Italy.
Trial summary
This pilot controlled study aims to evaluate the clinical and instrumental effects and feasibility of transcutaneous cervical spinal cord stimulation (tSCS) combined with conventional rehabilitation in adults with spinal cord injury (SCI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- ExaStim® Transcutaneous Spinal Cord Stimulation and Conventional Rehabilitation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- Nov 2026to Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years.
- Diagnosis of non-progressive spinal cord injury.
- American Spinal Injury Association Impairment Scale (AIS) grade A, B, or C.
- Motor function impairment resulting from spinal cord injury and consistent with the rehabilitation objectives of the study.
- Clinically stable condition compatible with participation in the rehabilitation program defined by the study protocol.
- Intact skin in the areas where stimulation electrodes will be applied.
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- Ability to tolerate transcutaneous stimulation during the preliminary stimulation parameter setting/titration phase.
- No botulinum toxin treatment within the 6 months prior to enrollment.
- Ability to understand and follow study procedures, directly or, where appropriate, with caregiver support.
- Written informed consent provided by the participant or, where applicable, by a legally authorized representative.
Who cannot join
- Unstable or progressive spinal cord injury.
- Acute medical conditions under active treatment that contraindicate standard rehabilitation.
- Uncontrolled or inadequately managed autonomic dysreflexia.
- Clinically significant and inadequately controlled orthostatic hypotension.
- Uncontrolled epilepsy or seizures.
- Uncontrolled cardiopulmonary disease or inadequately controlled cardiac arrhythmias.
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- Unhealed bone fractures or other painful musculoskeletal conditions incompatible with the planned rehabilitation treatment.
- Damaged, infected, inflamed, or otherwise unsuitable skin in the areas where stimulation electrodes will be applied.
- Known allergy to device or electrode materials, including hydrogel, silicone, or latex.
- Presence of implanted electronic devices, including pacemakers, defibrillators, neurostimulators, or other implantable electronic devices.
- Presence of internal metallic objects of unknown origin or without adequate documentation.
- Pregnancy.
- Morbid obesity.
- Dependence on mechanical ventilation.
- Uncontrolled or unstable psychiatric disorders, untreated depression, or active substance abuse when these conditions may interfere with safe and appropriate participation in study procedures.
- Any other clinical condition that, in the investigator's judgment, makes participation in the study unsafe or inappropriate.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Transcutaneous Spinal Cord Stimulation in Neurorehabilitation for Spinal Cord Injury: A Controlled Pilot Study of Clinical and Instrumental Outcomes
This pilot controlled study aims to evaluate the clinical and instrumental effects and feasibility of transcutaneous cervical spinal cord stimulation (tSCS) combined with conventional rehabilitation in adults with spinal cord injury (SCI).
A total of 20 participants will be enrolled and assigned to two parallel groups. The experimental group will receive conventional rehabilitation combined with transcutaneous cervical spinal cord stimulation using the ExaStim® system, while the control group will receive conventional rehabilitation alone. In the experimental group, stimulation will be delivered twice weekly for 4 weeks, for a total of 8 sessions.
The study will primarily explore the immediate effects of a single stimulation session on motor control and muscle tone. It will also assess changes in motor function, muscle tone, and clinical, robotic, and electrophysiological measures over the 4-week intervention period, as well as feasibility, tolerability, and adverse events. Comparisons between the experimental and control groups will be exploratory, consistent with the pilot nature of the study.
- Conditions
- Spinal Cord Injury
- Being tested
- ExaStim® Transcutaneous Spinal Cord Stimulation, Conventional Rehabilitation
- 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.
ExaStim® Transcutaneous Spinal Cord StimulationDevice
Transcutaneous cervical spinal cord stimulation (tSCS) will be delivered using the ExaStim® system through surface electrodes applied at the cervical level. Stimulation parameters, including electrode configuration, intensity, pulse duration, and frequency, will be individualized according to the participant's clinical response and tolerability. Stimulation will be administered in combination with conventional rehabilitation twice weekly for 4 weeks, for a total of 8 sessions, with each session lasting approximately 30-60 minutes.
Conventional RehabilitationOther
Participants will receive the conventional rehabilitation program provided as part of their standard clinical rehabilitation pathway. In the experimental arm, conventional rehabilitation will be combined with transcutaneous cervical spinal cord stimulation, whereas participants in the control arm will receive conventional rehabilitation alone.
| Study group | Role | What they receive |
|---|---|---|
| Transcutaneous Spinal Cord Stimulation + Rehabilitation | Experimental | Participants will receive conventional rehabilitation combined with transcutaneous cervical spinal cord stimulation (tSCS) using the ExaStim® system. Stimulation will be administered twice weekly for 4 weeks, for a total of 8 sessions, with each session lasting approximately 30-60 minutes. Stimulation parameters will be individualized according to the participant's clinical response and tolerability. Receives: Device: ExaStim® Transcutaneous Spinal Cord Stimulation; Other: Conventional Rehabilitation |
| Conventional Rehabilitation | Active comparator | Participants will receive conventional rehabilitation alone without transcutaneous cervical spinal cord stimulation during the 4-week study period. Receives: Other: Conventional Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Finger Strength
Finger flexion and extension strength will be assessed using the AMADEO robotic device and expressed in Newtons (N).
Measured: Immediately before and immediately after each stimulation session, twice weekly for 4 weeks
Finger Range of Motion
Finger range of motion (ROM) will be assessed using the AMADEO robotic device and expressed as a percentage (%).
Measured: Immediately before and immediately after each stimulation session, twice weekly for 4 weeks
Finger Muscle Tone
Finger muscle tone will be assessed using the AMADEO robotic device by measuring passive resistance during finger movement, expressed in Newtons (N).
Measured: Immediately before and immediately after each stimulation session, twice weekly for 4 weeks
Finger Spasticity
Finger spasticity will be assessed using the AMADEO robotic device at three different movement velocities.
Measured: Immediately before and immediately after each stimulation session, twice weekly for 4 weeks
Hand Grip Strength
Hand grip strength will be measured using a digital hand grip dynamometer and expressed in kilograms (kg).
Measured: Immediately before and immediately after each stimulation session, twice weekly for 4 weeks
Muscle Activation
Muscle activation during motor tasks will be assessed using surface electromyography (sEMG). Raw electromyographic signals will be recorded in microvolts (µV).
Measured: Immediately before and immediately after each stimulation session, twice weekly for 4 weeks
Secondary outcomes (13)
Muscle Strength
Muscle strength will be assessed using the Medical Research Council (MRC) scale, which grades muscle strength from 0 (no muscle contraction) to 5 (normal muscle strength).
Measured: Baseline and end of the 4-week intervention period.
Spasticity
Spasticity will be assessed using the Modified Ashworth Scale (MAS), an ordinal scale ranging from 0 (no increase in muscle tone) to 4 (affected part rigid in flexion or extension), including an intermediate 1+ category.
Measured: Baseline and end of the 4-week intervention period.
Upper Limb Functional Performance
Upper limb functional performance will be assessed using the Van Lieshout Test (VLT), in which individual tasks are scored from 0 (unable to perform the task) to 5 (independent and optimal performance).
Measured: Baseline and end of the 4-week intervention period.
Hand Grip Strength
Hand grip strength will be measured using a digital hand grip dynamometer and expressed in kilograms (kg).
Measured: Baseline and end of the 4-week intervention period.
Finger Strength
Finger flexion and extension strength will be assessed using the AMADEO robotic device and expressed in Newtons (N).
Measured: Baseline and end of the 4-week intervention period.
Finger Range of Motion
Finger range of motion (ROM) will be assessed using the AMADEO robotic device and expressed as a percentage (%).
Measured: Baseline and end of the 4-week intervention period.
Finger Muscle Tone
Finger muscle tone will be assessed using the AMADEO robotic device by measuring passive resistance during finger movement, expressed in Newtons (N).
Measured: Baseline and end of the 4-week intervention period.
Finger Spasticity
Finger spasticity will be assessed using the AMADEO robotic device at three different movement velocities.
Measured: Baseline and end of the 4-week intervention period.
Muscle Activation
Muscle activation during motor tasks will be assessed using surface electromyography (sEMG). Raw electromyographic signals will be recorded in microvolts (µV).
Measured: Baseline and end of the 4-week intervention period.
Neurological Motor Function
Neurological motor function will be assessed using the motor examination component of the American Spinal Injury Association (ASIA) neurological assessment.
Measured: Baseline and end of the 4-week intervention period.
Somatosensory Evoked Potential Latency
Somatosensory evoked potential (SEP) latency will be measured in milliseconds (ms) to characterize somatosensory pathway conduction.
Measured: Baseline and end of the 4-week intervention period.
Treatment Adherence
Treatment adherence will be assessed by recording the number of transcutaneous spinal cord stimulation sessions completed during the intervention period.
Measured: Throughout the 4-week intervention period.
Adverse Events
Adverse events observed or reported during the study will be recorded, including their nature, severity, duration or outcome, relationship to the device or procedure, and any actions taken.
Measured: Throughout the 4-week intervention period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionNov 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuryStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ernesto Losavio
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ernesto Losavio, Istituti Clinici Scientifici Maugeri SpA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07893470
- Sponsor's protocol ID
- NEUROSTIM-SCI
- Acronym
- NEUROSTIM-SCI
- Status last verified
- Oct 2026
- First submitted
- 7 Oct 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcutaneous Spinal Cord Stimulation in Neurorehabilitation for Spinal Cord Injury: A Controlled Pilot Study of Clinical and Instrumental Outcomes
- ClinicalTrials.gov ID
- NCT07893470
- Acronym / sponsor ID
- NEUROSTIM-SCI / NEUROSTIM-SCI
- Conditions
- Spinal Cord Injury
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Ernesto LosavioUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 26 Oct 2026 (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.
This pilot controlled study aims to evaluate the clinical and instrumental effects and feasibility of transcutaneous cervical spinal cord stimulation (tSCS) combined with conventional rehabilitation in adults with spinal cord injury (SCI).
A total of 20 participants will be enrolled and assigned to two parallel groups. The experimental group will receive conventional rehabilitation combined with transcutaneous cervical spinal cord stimulation using the ExaStim® system, while the control group will receive conventional rehabilitation alone. In the experimental group, stimulation will be delivered twice weekly for 4 weeks, for a total of 8 sessions.
The study will primarily explore the immediate effects of a single stimulation session on motor control and muscle tone. It will also assess changes in motor function, muscle tone, and clinical, robotic, and electrophysiological measures over the 4-week intervention period, as well as feasibility, tolerability, and adverse events. Comparisons between the experimental and control groups will be exploratory, consistent with the pilot nature of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transcutaneous Spinal Cord Stimulation + Rehabilitation | Experimental | Device: ExaStim® Transcutaneous Spinal Cord Stimulation, Other: Conventional RehabilitationParticipants will receive conventional rehabilitation combined with transcutaneous cervical spinal cord stimulation (tSCS) using the ExaStim® system. Stimulation will be administered twice weekly for 4 weeks, for a total of 8 sessions, with each session lasting approximately 30-60 minutes. Stimulation parameters will be individualized according to the participant's clinical response and tolerability. |
| Conventional Rehabilitation | Active comparator | Other: Conventional RehabilitationParticipants will receive conventional rehabilitation alone without transcutaneous cervical spinal cord stimulation during the 4-week study period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age ≥18 years.
- Diagnosis of non-progressive spinal cord injury.
- American Spinal Injury Association Impairment Scale (AIS) grade A, B, or C.
- Motor function impairment resulting from spinal cord injury and consistent with the rehabilitation objectives of the study.
- Clinically stable condition compatible with participation in the rehabilitation program defined by the study protocol.
Key exclusion criteria (16 listed)
- Unstable or progressive spinal cord injury.
- Acute medical conditions under active treatment that contraindicate standard rehabilitation.
- Uncontrolled or inadequately managed autonomic dysreflexia.
- Clinically significant and inadequately controlled orthostatic hypotension.
- Uncontrolled epilepsy or seizures.
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 |
|---|---|---|
| ExaStim® Transcutaneous Spinal Cord StimulationTranscutaneous cervical spinal cord stimulation (tSCS) will be delivered using the ExaStim® system through surface electrodes applied at the cervical level. Stimulation parameters, including electrode configuration, intensity, pulse duration, and frequency, will be individualized according to the participant's clinical response and tolerability. Stimulation will be administered in combination with conventional rehabilitation twice weekly for 4 weeks, for a total of 8 sessions, with each session lasting approximately 30-60 minutes. | Device | Transcutaneous Spinal Cord Stimulation + Rehabilitation |
| Conventional RehabilitationParticipants will receive the conventional rehabilitation program provided as part of their standard clinical rehabilitation pathway. In the experimental arm, conventional rehabilitation will be combined with transcutaneous cervical spinal cord stimulation, whereas participants in the control arm will receive conventional rehabilitation alone. | Other | Conventional Rehabilitation, Transcutaneous Spinal Cord Stimulation + Rehabilitation |
Primary outcome
Finger Strength
Time frame: Immediately before and immediately after each stimulation session, twice weekly for 4 weeks
Finger flexion and extension strength will be assessed using the AMADEO robotic device and expressed in Newtons (N).
Finger Range of Motion
Time frame: Immediately before and immediately after each stimulation session, twice weekly for 4 weeks
Finger range of motion (ROM) will be assessed using the AMADEO robotic device and expressed as a percentage (%).
Finger Muscle Tone
Time frame: Immediately before and immediately after each stimulation session, twice weekly for 4 weeks
Finger muscle tone will be assessed using the AMADEO robotic device by measuring passive resistance during finger movement, expressed in Newtons (N).
Finger Spasticity
Time frame: Immediately before and immediately after each stimulation session, twice weekly for 4 weeks
Finger spasticity will be assessed using the AMADEO robotic device at three different movement velocities.
Hand Grip Strength
Time frame: Immediately before and immediately after each stimulation session, twice weekly for 4 weeks
Hand grip strength will be measured using a digital hand grip dynamometer and expressed in kilograms (kg).
Muscle Activation
Time frame: Immediately before and immediately after each stimulation session, twice weekly for 4 weeks
Muscle activation during motor tasks will be assessed using surface electromyography (sEMG). Raw electromyographic signals will be recorded in microvolts (µV).
13 secondary outcomes
Muscle Strength
Time frame: Baseline and end of the 4-week intervention period.
Spasticity
Time frame: Baseline and end of the 4-week intervention period.
Upper Limb Functional Performance
Time frame: Baseline and end of the 4-week intervention period.
Hand Grip Strength
Time frame: Baseline and end of the 4-week intervention period.
Finger Strength
Time frame: Baseline and end of the 4-week intervention period.
Finger Range of Motion
Time frame: Baseline and end of the 4-week intervention period.
Finger Muscle Tone
Time frame: Baseline and end of the 4-week intervention period.
Finger Spasticity
Time frame: Baseline and end of the 4-week intervention period.
Muscle Activation
Time frame: Baseline and end of the 4-week intervention period.
Neurological Motor Function
Time frame: Baseline and end of the 4-week intervention period.
Somatosensory Evoked Potential Latency
Time frame: Baseline and end of the 4-week intervention period.
Treatment Adherence
Time frame: Throughout the 4-week intervention period.
Adverse Events
Time frame: Throughout the 4-week intervention period.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
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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.
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 ExaStim® Transcutaneous Spinal Cord Stimulation and Conventional Rehabilitation in people with Spinal Cord Injury, run by Ernesto Losavio at 1 site in Italy.
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 10 inclusion and 16 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: opening soon, as of the sponsor's last update on 26 Oct 2026. 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 Italy. 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. 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?
This study is still under way. Results are not available in the source record yet.
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?
Finger Strength (time frame: Immediately before and immediately after each stimulation session, twice weekly for 4 weeks). The study lists 6 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 26 Oct 2026.