NCT07893470|Not Yet Recruiting
Transcutaneous Spinal Cord Stimulation for Neurorehabilitation After Spinal Cord Injury
NEUROSTIM-SCI
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NEUROSTIM-SCI
Sponsor study identifier
interventional
20
1 country
1
Study Start
November 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
November 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
November 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 7, 2026
Actual (reported)October 26, 2026
Actual (reported)November 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
November 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
November 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Finger Strength
Finger flexion and extension strength will be assessed using the AMADEO robotic device and expressed in Newtons (N).
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 (%).
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).
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.
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).
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).
Immediately before and immediately after each stimulation session, twice weekly for 4 weeks
Muscle Strength
Baseline and end of the 4-week intervention period.
Spasticity
Baseline and end of the 4-week intervention period.
Upper Limb Functional Performance
Baseline and end of the 4-week intervention period.
Hand Grip Strength
Baseline and end of the 4-week intervention period.
Finger Strength
Baseline and end of the 4-week intervention period.
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.
Participants will receive conventional rehabilitation alone without transcutaneous cervical spinal cord stimulation during the 4-week study period.
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.
ICS Maugeri S.p.A. SB IRCCS Bari
Bari, Bari, 70124, Italy
First Submitted
October 7, 2026
First Posted
October 26, 2026
Study Start
November 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
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.
Contact the study team to confirm eligibility.
November 2027
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
November 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 26, 2026
Record last verified: 2026-10
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