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Not yet recruitingNCT07893470NEUROSTIM-SCIUpdated Oct 26, 2026

Transcutaneous Spinal Cord Stimulation for Neurorehabilitation After Spinal Cord Injury

An interventional study of ExaStim® Transcutaneous Spinal Cord Stimulation and Conventional Rehabilitation in Spinal Cord Injury, sponsored by Ernesto Losavio. Not yet recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-26.

Sponsored by Ernesto Losavio · Not applicable, Interventional, and Treatment

Updated Oct 26, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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).

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.

02

Conditions studied

  • Spinal Cord Injury
03

In context

Spinal Cord Injuries

1,991 studies on the registry are indexed under Spinal Cord Injuries; 516 are open to participants now.

This study's planned enrollment of 20 is below the median of 24 across 1,594 interventional studies indexed under Spinal Cord Injuries.

Browse Spinal Cord Injuries studies →

Lead sponsor

Ernesto Losavio is the lead sponsor of 2 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.
  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Transcutaneous Spinal Cord Stimulation + Rehabilitation

    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.

    Device: ExaStim® Transcutaneous Spinal Cord Stimulation · Other: Conventional Rehabilitation

  • Active comparator
    Conventional Rehabilitation

    Participants will receive conventional rehabilitation alone without transcutaneous cervical spinal cord stimulation during the 4-week study period.

    Other: Conventional Rehabilitation

Interventions

  • DeviceExaStim® Transcutaneous Spinal Cord Stimulation

    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.

  • OtherConventional Rehabilitation

    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.

06

What researchers measure

Primary outcomes

  1. Finger Strength

    Finger flexion and extension strength will be assessed using the AMADEO robotic device and expressed in Newtons (N).

    Time frame: Immediately before and immediately after each stimulation session, twice weekly for 4 weeks

  2. Finger Range of Motion

    Finger range of motion (ROM) will be assessed using the AMADEO robotic device and expressed as a percentage (%).

    Time frame: Immediately before and immediately after each stimulation session, twice weekly for 4 weeks

  3. 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).

    Time frame: Immediately before and immediately after each stimulation session, twice weekly for 4 weeks

  4. Finger Spasticity

    Finger spasticity will be assessed using the AMADEO robotic device at three different movement velocities.

    Time frame: Immediately before and immediately after each stimulation session, twice weekly for 4 weeks

  5. Hand Grip Strength

    Hand grip strength will be measured using a digital hand grip dynamometer and expressed in kilograms (kg).

    Time frame: Immediately before and immediately after each stimulation session, twice weekly for 4 weeks

  6. Muscle Activation

    Muscle activation during motor tasks will be assessed using surface electromyography (sEMG). Raw electromyographic signals will be recorded in microvolts (µV).

    Time frame: Immediately before and immediately after each stimulation session, twice weekly for 4 weeks

Secondary outcomes

  1. 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).

    Time frame: Baseline and end of the 4-week intervention period.

  2. 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.

    Time frame: Baseline and end of the 4-week intervention period.

  3. 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).

    Time frame: Baseline and end of the 4-week intervention period.

  4. Hand Grip Strength

    Hand grip strength will be measured using a digital hand grip dynamometer and expressed in kilograms (kg).

    Time frame: Baseline and end of the 4-week intervention period.

  5. Finger Strength

    Finger flexion and extension strength will be assessed using the AMADEO robotic device and expressed in Newtons (N).

    Time frame: Baseline and end of the 4-week intervention period.

  6. Finger Range of Motion

    Finger range of motion (ROM) will be assessed using the AMADEO robotic device and expressed as a percentage (%).

    Time frame: Baseline and end of the 4-week intervention period.

  7. 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).

    Time frame: Baseline and end of the 4-week intervention period.

  8. Finger Spasticity

    Finger spasticity will be assessed using the AMADEO robotic device at three different movement velocities.

    Time frame: Baseline and end of the 4-week intervention period.

  9. Muscle Activation

    Muscle activation during motor tasks will be assessed using surface electromyography (sEMG). Raw electromyographic signals will be recorded in microvolts (µV).

    Time frame: Baseline and end of the 4-week intervention period.

  10. Neurological Motor Function

    Neurological motor function will be assessed using the motor examination component of the American Spinal Injury Association (ASIA) neurological assessment.

    Time frame: Baseline and end of the 4-week intervention period.

  11. Somatosensory Evoked Potential Latency

    Somatosensory evoked potential (SEP) latency will be measured in milliseconds (ms) to characterize somatosensory pathway conduction.

    Time frame: Baseline and end of the 4-week intervention period.

  12. Treatment Adherence

    Treatment adherence will be assessed by recording the number of transcutaneous spinal cord stimulation sessions completed during the intervention period.

    Time frame: Throughout the 4-week intervention period.

  13. 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.

    Time frame: Throughout the 4-week intervention period.

07

Study locations

1 site
  • ICS Maugeri S.p.A. SB IRCCS Bari
    Bari, Bari 70124, Italy
08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Nov 2026; primary completion for Nov 2027, 12 months later.

Of 766 non-industry interventional studies with no phase under Spinal Cord Injuries, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 65. This study's planned 12 months is below that.

Counting every sponsor, half of 816 studies reached it within 35 months; a quarter within 16 and three quarters within 65.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 7, 2026
First posted
Oct 26, 2026
StartEst.
Nov 2026
Primary completionEst.
Nov 2027
CompletionEst.
Nov 2027
Last update
Oct 26, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 26, 2026
Show all 1 update
  1. Oct 26, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07893470
Lead sponsor
Ernesto Losavio
Responsible party
Ernesto Losavio (Director of the Neurorehabilitation and Spinal Unit, ICS Maugeri IRCCS Bari, Italy, Istituti Clinici Scientifici Maugeri SpA) — Sponsor-investigator
First posted
Oct 26, 2026
Start date
Nov 2026 (estimated)
Primary completion
Nov 2027 (estimated)
Completion
Nov 2027 (estimated)
Last update
Oct 26, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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