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Spinal Cord InjuriesSCS-CorENCT03815721

Carry-over Effects of Repetitively Applied Transcutaneous Spinal Cord Stimulation on Spasticity

A study testing Stimulette r2x+ in people with Spinal Cord Injuries and Spasticity, Muscle, run by Swiss Paraplegic Research, Nottwil at 1 site in Switzerland.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Spinal cord injury is a devastating condition, causing substantial impairment of vital body functions caudal to the lesion. A major cause of disability stems from spasticity, a common secondary sequelae. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Spinal Cord Injuries, Spasticity, Muscle
What is being tested?
Stimulette r2x+
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteSwitzerland
Study dates
7 Jan 2019to 10 May 2021
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • motor and sensory incomplete spinal cord injury classified as grade C or D on the American Spinal Injury Association Impairment Scale
  • neurological level of spinal cord injury: third cervical to tenth thoracic segment
  • chronic condition (≥ 12 months post-spinal cord injury)
  • preserved segmental and cutaneo-muscular reflexes in the lower limbs
  • able to be verticalized for 6 minutes (with walking aids)
  • preserved joint mobility, no musculoskeletal diseases
  • spasticity (with/without antispasticity medication)
  • stable antispasmodic medication one month prior to as well as during study participation

Who cannot join

  • neuromuscular diseases, e.g., amyotrophic lateral sclerosis (ALS), Parkinson's disease, Guillain-Barré syndrome, muscular dystrophy
  • dermatological issues at the stimulation site
  • acute urinary tract infection at study entry
  • active implants (e.g., cardiac pacemaker, drug pump)
  • passive implants between the ninth thoracic level and the first lumbal level (e.g. metal screws/plates for surgical stabilization of spinal fractures)
  • malignant diseases
  • heart insufficiency
  • potential pregnancy (pregnancy test to be conducted as part of the first evaluation)

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • Swiss Paraplegic Centre

    Nottwil, Canton of Lucerne, 6207

Other trials in Switzerland

About this study

Official title: Carry-over Effects of Repetitively Applied Transcutaneous Spinal Cord Stimulation on Spasticity and Residual Motor Control in Incomplete Spinal Cord Injured Individuals

Spinal cord injury is a devastating condition, causing substantial impairment of vital body functions caudal to the lesion. A major cause of disability stems from spasticity, a common secondary sequelae. Its various clinical manifestations include spasms, clonus, and resistance to passive movements, and often present a major hindrance in rehabilitation, further deteriorate residual motor performance, and negatively impact independence and quality of life. Despite its high prevalence, successful management of spasticity has remained difficult. Standard-of-care treatment modalities are often insufficient or bear the risk of undesirable side effects further accentuating paresis. Epidural stimulation of the lumbar spinal cord via implanted electrodes provides for an alternative approach. It works through modifying the dysregulated neural signal processing of spared spinal circuitry caudal to the injury. Its ameliorative effects on severe lower-limb spasticity have been repetitively reported. Yet, epidural spinal cord stimulation in motor disorders is still off-label, applied in relatively few patients only, also because of its invasive character, the time consuming testing phase for its effective application, and the lack of markers to identify responders in advance. With the development of transcutaneous spinal cord stimulation, a method became available to activate the same input structures to the lumbar spinal cord as with epidural stimulation and hence to induce similar neuromodulatory effects, yet non-invasively, using standard equipment available at rehabilitation centers. A recent proof-of-concept study has shown that a single 30-minute session of transcutaneous spinal cord stimulation controlled various clinical signs of spasticity and augmented residual motor control in spinal cord injured individuals for several hours beyond its application. Further, in one subject, the stimulation was repetitively applied for six weeks, resulting in cumulative therapeutic effects persisting for 10 days after its discontinuation. These observations strongly suggest that the stimulation can induce beneficial neuroplastic adaptations of spared spinal systems and their interaction with residual supraspinal control. The proposed research aims at studying the reproducibility of these findings in a statistically sound cohort of individuals with spinal cord injury and testing the applicability and acceptance of transcutaneous spinal cord stimulation as a home-based therapy.

Being tested
Stimulette r2x+
Medical subject headings
Spinal Cord Injuries, Muscle Spasticity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Stimulette r2x+Device

    device for repetitive transcutaneous spinal cord stimulation

Study groups in NCT03815721
Study groupRoleWhat they receive
daily stimulationExperimental30-minute sessions of transcutaneous spinal cord stimulation using the Stimulette r2x+ will be repetitively applied 7 times per week.
Receives: Device: Stimulette r2x+
stimulation every other dayExperimental30-minute sessions of transcutaneous spinal cord stimulation using the Stimulette r2x+ will be repetitively applied 3 times per week.
Receives: Device: Stimulette r2x+

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in spasticity index

    Spasticity index based on the Wartenberg pendulum test: For the pendulum test, subjects will be in a supported sitting position with the trunk reclined approximately 30°. The examiner will lift one leg to a horizontal position, release it, and let it oscillate passively until it stops. The pendulum test will be repeated three times on each side, separated by phases of relaxation. The spasticity index is calculated subtracting the knee angle of the initial horizontal leg position from the peak flexion angle of the first swing divided by the final knee resting angle. Scores ≥ 1 denote non-spastic conditions, and 0 extreme spasticity.

    Measured: from day 1 to day 57

Secondary outcomes (7)

  1. Change in numeric rating scale spasticity

    The severity of spasticity is rated using a numeric rating scale from a minimum of 0 to a maximum of 10. Higher values represent worse outcome.

    Measured: day 1, 8, 29, 50 and 57

  2. Change in Modified Ashworth Scale

    The resistance to passive movement will be clinically graded according to the Modified Ashworth Scale. Individual scores from both legs will be summed (with a value of 1.5 for the 1+ scoring category) to result in a single Modified Ashworth Scale-sum score (0-96; 0, no increase in muscle tone) per assessment. Higher values represent worse outcome.

    Measured: from day 1 to day 57

  3. Change in adductor tone rating

    5-point ordinal scale describing adductor tone during passive abduction (0: normal tone - 4: maximal tone). Higher values represent worse outcome.

    Measured: from day 1 to day 57

  4. Change in Penn Spasm Frequency Scale

    5-point scale rating the frequency and severity of spasms (0: no spasms - 4: more than 10 spasms per hour). Higher values represent worse outcome.

    Measured: from day 1 to day 57

  5. Change in resistance of the lower limbs

    Measure of the resistance of the lower limbs to manipulation performed by a robotic system (MotionMaker, SWORTEC SA). The MotionMaker measures torque (N) and power output (W).

    Measured: from day 1 to day 57

  6. Change in 6-minute walk test

    distance in meters walked over a span of 6 minutes

    Measured: from day 1 to day 57

  7. Change in Walking Index for Spinal Cord Injury II Scale

    21-point ordinal scale that rates the extent and nature of assistance (e.g., walker, crutches, cane, braces, physical assistance) required to complete the 10-m walk test (0: unable to complete the test - 20: ambulated without any assistance). Higher values represent better outcome.

    Measured: from day 1 to day 57

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jan 2019
  2. Study start7 Jan 2019
  3. Primary completion10 May 2021
  4. Study completion10 May 2021

Why it stopped: Study terminated by the PIs due to unexpected outcomes

Resources

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
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03815721
Sponsor's protocol ID
2016-16
Acronym
SCS-CorE
Status last verified
Nov 2025
First submitted
22 Jan 2019
Last updated
26 Nov 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Stimulette r2x+ in people with Spinal Cord Injuries and Spasticity, Muscle, run by Swiss Paraplegic Research, Nottwil at 1 site in Switzerland.

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 8 inclusion and 8 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: stopped early, as of the sponsor's last update on 26 Nov 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 Switzerland. 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?

The study was stopped early (reason given: Study terminated by the PIs due to unexpected outcomes). Results are not available in the source record.

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?

Change in spasticity index (time frame: from day 1 to day 57). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03815721.

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 Nov 2025.

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