Pilot Study of tSCS for Improving Upper Limb Function in People With M
Transcutaneous Electrical Spinal Stimulation (tSCS) for Improving Upper Limb Function in People With MS
What it found
No result yet.
What was tested
Treatment tested
- Active stimulation tSCS
Placebo
- Sham: stimulations using a non-active electric stimulation
Given to everyone in the trial
- Occupational/Upper Limb Rehabilitation Therapy
What it measured
Main measures
Change in Upper Limb Function (9-Hole Peg Test)
Baseline and Week 12
Disability progressionArm and hand function
Other measures (6)
Change in Hand Grip Strength (Dynamometry)
Baseline and Week 12
Arm and hand functionPhysical functionChange in Quality of Life (EQ-5D-5L)
Baseline and Week 12
Walking and mobilityPainMood and sleepQuality of life (reported by participants)Change in Fatigue (Modified Fatigue Impact Scale - MFIS)
Baseline and Week 12
Thinking and memoryFatigueChange in Manual Dexterity (Box and Block Test)
Baseline and Week 12
Arm and hand functionPatient-Reported Upper Limb Function (Multiple Sclerosis Impact Scale - MSIS-29, upper limb subitems)
Baseline and Week 12
Arm and hand functionQuality of life (reported by participants)Safety and Tolerability
Baseline through Week 12
Quality of life (reported by participants)Safety
Who could take part
MS (type not specified) · 18 to 70 · EDSS 3.0 to 6.5
Show the full criteria
Inclusion criteria
* Age between 18 and 70 years. * Diagnosis of Multiple Sclerosis (according to revised McDonald criteria). * Upper limb dysfunction (9-Hole Peg Test score ≥ 20% slower than normative values). * Stable disease-modifying treatment for ≥ 6 months before enrollment. * Expanded Disability Status Scale (EDSS) score between 3.0 and 6.5. * Ability to provide informed consent.
Exclusion criteria
* Relapse or corticosteroid treatment within the last 3 months. * Severe spasticity of the upper limb (Modified Ashworth Scale > 3). * Implanted electrical devices (pacemaker, spinal cord stimulator). * Epilepsy or uncontrolled seizures. * Severe psychiatric disorders or cognitive impairment interfering with study procedures. * Pregnant or breastfeeding women. * Participation in another interventional clinical trial within the last 3 months.
As registered. Criteria can change, so ask the trial team or your neurologist.
Contact details on the registryAbout this trial
In the sponsor's words
The goal of this clinical trial is to evaluate whether non-invasive spinal cord neuromodulation with the SCONE™ device can improve upper limb function in people with multiple sclerosis. The study will investigate if combining SCONE™ therapy with rehabilitation exercises leads to improvements in arm and hand movement, and whether the therapy is safe and well tolerated in this patient population. Participants will receive non-invasive spinal cord stimulation with the SCONE™ device and perform rehabilitation exercises specifically focused on the upper limb.
Papers
Background
Inanici F, Samejima S, Gad P, Edgerton VR, Hofstetter CP, Moritz CT. Transcutaneous Electrical Spinal Stimulation Promotes Long-Term Recovery of Upper Extremity Function in Chronic Tetraplegia. IEEE Trans Neural Syst Rehabil Eng. 2018 Jun;26(6):1272-1278. doi: 10.1109/TNSRE.2018.2834339.Background
Moritz C, Field-Fote EC, Tefertiller C, van Nes I, Trumbower R, Kalsi-Ryan S, Purcell M, Janssen TWJ, Krassioukov A, Morse LR, Zhao KD, Guest J, Marino RJ, Murray LM, Wecht JM, Rieger M, Pradarelli J, Turner A, D'Amico J, Squair JW, Courtine G. Non-invasive spinal cord electrical stimulation for arm and hand function in chronic tetraplegia: a safety and efficacy trial. Nat Med. 2024 May;30(5):1276Background
Tu YH, Stiles ML, Allen LV Jr, Olsen KM, Barton CI, Greenwood RB. Stability of amoxicillin trihydrate-potassium clavulanate in original containers and unit dose oral syringes. Am J Hosp Pharm. 1988 May;45(5):1092-9.Background
Barss TS, Parhizi B, Porter J, Mushahwar VK. Neural Substrates of Transcutaneous Spinal Cord Stimulation: Neuromodulation across Multiple Segments of the Spinal Cord. J Clin Med. 2022 Jan 27;11(3):639. doi: 10.3390/jcm11030639.Background
Waltz JM, Andreesen WH, Hunt DP. Spinal cord stimulation and motor disorders. Pacing Clin Electrophysiol. 1987 Jan;10(1 Pt 2):180-204. doi: 10.1111/j.1540-8159.1987.tb05947.x.Background
Wallin MT, Culpepper WJ, Campbell JD, Nelson LM, Langer-Gould A, Marrie RA, Cutter GR, Kaye WE, Wagner L, Tremlett H, Buka SL, Dilokthornsakul P, Topol B, Chen LH, LaRocca NG; US Multiple Sclerosis Prevalence Workgroup. The prevalence of MS in the United States: A population-based estimate using health claims data. Neurology. 2019 Mar 5;92(10):e1029-e1040. doi: 10.1212/WNL.0000000000007035. Epub 2
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History
Started
Oct 2025
Main results due
Dec 2026
Finished
Dec 2026