Pilot Study of tSCS for Improving Upper Limb Function in People With Multiple Sclerosis

NCT07152145 | Not Yet Recruiting FDA Device

• 1 other identifier: tSCS-MS-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Multiple Sclerosis

Keywords

Spinal Cord Neuromodulation; Non-invasive neuromodulation; Upper limb function; Neurorehabilitation

Outcome Measures

Primary Outcomes (1)

• Change in Upper Limb Function (9-Hole Peg Test)

  The 9-Hole Peg Test (9HPT) is a validated quantitative measure of upper extremity function. Participants are timed while placing and removing nine pegs into holes on a board as quickly as possible. Performance is recorded as time to completion. Change from baseline will be compared between active and sham groups.

  Baseline and Week 12

Secondary Outcomes (6)

• Change in Hand Grip Strength (Dynamometry)

  Baseline and Week 12

• Change in Quality of Life (EQ-5D-5L)

  Baseline and Week 12

• Change in Fatigue (Modified Fatigue Impact Scale - MFIS)

  Baseline and Week 12

• Change in Manual Dexterity (Box and Block Test)

  Baseline and Week 12

• Patient-Reported Upper Limb Function (Multiple Sclerosis Impact Scale - MSIS-29, upper limb subitems)

  Baseline and Week 12

Study Arms (2)

Active tSCS + Rehabilitation

EXPERIMENTAL

Participants will receive active transcutaneous spinal cord stimulation (tSCS) using the SCONE™ device, combined with conventional upper limb rehabilitation therapy.

Device: Active stimulation tSCS; Behavioral: Occupational/Upper Limb Rehabilitation Therapy

Sham tSCS + Rehabilitation

SHAM COMPARATOR

Participants will receive sham stimulation using the SCONE™ device without active current, combined with conventional upper limb rehabilitation therapy. The setup will be identical to the active intervention to maintain blinding.

Device: Sham: stimulations using a non-active electric stimulation; Behavioral: Occupational/Upper Limb Rehabilitation Therapy

Interventions

Active stimulation tSCS DEVICE

Active transcutaneous spinal cord stimulation (tSCS) delivered with the SCONE™ device. Electrical currents are applied non-invasively through surface electrodes placed on the skin over the spine. Sessions are combined with standardized upper limb rehabilitation therapy. Participants receive stimulation twice per week for 12 weeks.

Active tSCS + Rehabilitation

Sham: stimulations using a non-active electric stimulation DEVICE

Sham stimulation delivered with the SCONE™ device, using identical setup and procedures as the active intervention but without effective current. This procedure is designed to mimic the sensation and experience of active stimulation while delivering no therapeutic neuromodulation. Participants also perform standardized upper limb rehabilitation therapy twice per week for 12 weeks.Transcutaneous Spinal Cord Stimulation (tSCS) - Sham (SCONE™)

Sham tSCS + Rehabilitation

Occupational/Upper Limb Rehabilitation Therapy BEHAVIORAL

Standardized occupational therapy program focused on upper limb function. Sessions are delivered in combination with either active or sham transcutaneous spinal cord stimulation.

Active tSCS + Rehabilitation; Sham tSCS + Rehabilitation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Parc de Salut Mar: lead

Study Sites (1)

Hospital del Mar

Barcelona, 08003, Spain

Location

Related Publications (6)

• 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.

  PMID: 29877852 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):1276-1283. doi: 10.1038/s41591-024-02940-9. Epub 2024 May 20.

  PMID: 38769431 BACKGROUND

• 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.

  PMID: 3400652 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.

  PMID: 35160091 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.

  PMID: 2436177 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 2019 Feb 15.

  PMID: 30770430 BACKGROUND

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Neurology Department, Hospital del Mar Research Institute

Study Record Dates

• First Submitted: August 22, 2025
• First Posted: September 3, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 3, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: IPD and supporting documents will be available within 12 months after publication of the main results and will remain available for a minimum of 5 years thereafter.
• Access Criteria: Access will be granted to qualified researchers with a sound scientific proposal for secondary analyses related to multiple sclerosis or neuromodulation. Requests will be reviewed by the study steering committee. Data will be shared through a secure data-sharing platform after signing a data access agreement to ensure confidentiality and appropriate use.

Locations

ES (1)