Spinal Cord Stimulation for Poststroke Spasticity

NCT07744659 | Not Yet Recruiting DMC

• 1 other identifier: SCS-PNS0102&PINS-C2-01-53
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn whether spinal cord stimulation (SCS) is effective in treating post-stroke spasticity in adults. It will also evaluate the safety of the implanted SCS system. The main questions it aims to answer are:

1. 1.Does active SCS reduce limb spasticity compared with sham stimulation?
2. 2.What device-related problems do participants experience during the study?
3. 3.Have an SCS system surgically implanted
4. 4.Be randomly assigned to receive active SCS or sham SCS for 6 weeks
5. 5.After completion of the 6-week randomized comparison period, active stimulation will be initiated for all participants.
6. 6.Attend a post-operative visit within 3 to 7 days after surgery for device activation or sham activation, programming, safety checks, and study assessments
7. 7.Attend follow-up visits for study assessments at approximately 6, 12, 24 weeks, 1 year and 2 years after randomization
8. 8.Complete assessments of muscle spasticity, joint range of motion, motor function, walking ability, daily functioning, pain, and quality of life
9. 9.Report any medical problems or device-related problems during the study

Conditions

Spasticity Post Stroke

Keywords

Spinal Cord Stimulation; Spasticity; Limb function; Stroke; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• Change in Mean Modified Ashworth Scale Score of the Primary Target Muscle Groups From Baseline to Week 6

  The primary outcome is the change in the mean Modified Ashworth Scale (MAS) score of the Primary Target Muscle Groups from baseline to Week 6. The Primary Target Muscle Groups are selected from a upper or lower limb before treatment and must include at least two muscle groups. For the upper limb, eligible muscle groups include the shoulder adductors, shoulder internal rotators, elbow flexors, elbow extensors, forearm pronators, wrist flexors, and finger flexors. For the lower limb, eligible muscle groups include the hip flexors, hip adductors, hip internal rotators, knee flexors, knee extensors, and ankle plantar flexors. For analysis, the original MAS grades are converted to a 0-5 numerical scale, with grade 1+ converted to 2 and grades 2, 3, and 4 converted to 3, 4, and 5, respectively. The mean MAS score is calculated across the selected Primary Target Muscle Groups. Change is calculated as the Week 6 mean MAS score minus the baseline mean MAS score.

  Baseline to Week 6 after randomization

Secondary Outcomes (9)

• Change in Modified Ashworth Scale Scores of the Primary Target Muscle Groups From Baseline

  Day 0, Week 6, Week 12, Week 24, Year 1, and Year 2 after randomization

• Proportion of Participants With an Improvement in Mean Modified Ashworth Scale Score of at Least 1 Point

  Day 0, Week 6, Week 12, Week 24, Year 1, and Year 2 after randomization

• Change in Active and Passive Joint Range of Motion From Baseline

  Day 0, Week 6, Week 12, Week 24, Year 1, and Year 2 after randomization

• Change in Fugl-Meyer Assessment Score From Baseline

  Day 0, Week 6, Week 12, Week 24, Year 1, and Year 2 after randomization

• Change in Functional Independence Measure Score From Baseline

  Day 0, Week 6, Week 12, Week 24, Year 1, and Year 2 after randomization

Study Arms (2)

SCS Group

EXPERIMENTAL

Active SCS

Device: Active spinal cord stimulation

Control Group

ACTIVE COMPARATOR

Sham SCS

Device: Sham spinal cord stimulation

Interventions

Active spinal cord stimulation DEVICE

Participants will receive therapeutic electrical stimulation through the implanted spinal cord stimulation system beginning on Day 0, defined as the day of active or sham activation within 3-7 days after surgery. An individualized SCS programming strategy will be used. Initial stimulation parameters will include a frequency of 40-60 Hz, a pulse width of 200-300 μs, and a low starting amplitude that will be gradually increased according to participant tolerance. For participants with concomitant conditions such as pain, the stimulation frequency may be increased as clinically appropriate. Intermittent stimulation will be preferred, and electrode contact combinations will be individually selected. Active stimulation will continue through the 24-week follow-up

SCS Group

Sham spinal cord stimulation DEVICE

Participants will undergo the same implantation and programming procedures. On Day 0, the implanted system will be turned on, but the stimulation amplitude will be set to 0 mA so that no effective electrical stimulation is delivered during the 6-week randomized comparison period. After completion of the Week 6 assessment, participants will receive active SCS using the same individualized programming principles as the Active SCS Group. Active stimulation will continue through the 24-week follow-up.

Control Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged ≥18 years and \<75 years, regardless of sex;
• Diagnosed with ischemic or hemorrhagic stroke, with unilateral or single-limb motor dysfunction persisting for at least 6 months;
• The primary brain lesion and its underlying cause are clinically stable;
• Presence of unilateral upper- or lower-limb spasticity, with a Modified Ashworth Scale (MAS) grade of ≥2 in at least two muscle groups of the affected limb;
• Post-stroke limb dysfunction has not reached the treatment goal despite previous interventions, such as physical therapy and oral medications, and the participant's condition has shown no recent improvement;
• The type and dose of existing rehabilitation therapy and oral antispastic medications must remain unchanged during the study;
• Willing and able to complete all study visits and procedures;
• Able to understand the study and provide written informed consent.

You may not qualify if:

• Any contraindication to spinal cord stimulation surgery;
• Uncontrolled refractory epilepsy;
• Presence of tonic spasticity, such as decorticate rigidity or decerebrate rigidity;
• Poorly controlled severe psychiatric or cognitive impairment, defined as a Beck Depression Inventory-II score \>25 or a Mini-Mental State Examination score \<24;
• Active systemic infection;
• Presence of an implanted neurostimulator or drug delivery system;
• Botulinum toxin treatment within 4 months before enrollment;
• Plans to initiate any new treatment during the study that may affect limb movement, including chemical denervation therapies (such as botulinum toxin), oral antispastic medications, surgical procedures (such as peripheral neurotomy or contralateral C7 nerve transfer), or other physical therapy interventions;
• Pregnancy, breastfeeding, or planned pregnancy during the study;
• The participant or family is unable or unwilling to participate in long-term SCS treatment management;
• Participation in another clinical study within 4 weeks before signing informed consent;
• Any other condition that, in the investigator's judgment, makes the individual unsuitable for participation in the study.

Sponsors & Collaborators

• Beijing Pins Medical Co., Ltd: lead
• China-Japan Friendship Hospital: collaborator
• Beijing Sanbo Brain Hospital: collaborator
• Xuanwu Hospital, Beijing: collaborator
• Beijing Tiantan Hospital: collaborator
• Beijing Chao Yang Hospital: collaborator
• Beijing Tsinghua Changgeng Hospital: collaborator
• Xiangya Hospital of Central South University: collaborator
• West China Hospital: collaborator
• First Affiliated Hospital, Sun Yat-Sen University: collaborator
• RenJi Hospital: collaborator
• Qilu Hospital of Shandong University: collaborator
• The First Affiliated Hospital of Zhengzhou University: collaborator
• Nanjing Brian Hospital: collaborator
• Second Affiliated Hospital, Zhejiang University, School of Medicine: collaborator
• First Affiliated Hospital of Xinjiang Medical University: collaborator
• Peking University Aerospace Center Hospital: collaborator
• Anhui Provincial Hospital: collaborator

Study Sites (1)

China-Japan Friendship Hospital

Beijing, China

Location

Related Publications (8)

• Creamer M, Cloud G, Kossmehl P, Yochelson M, Francisco GE, Ward AB, Wissel J, Zampolini M, Abouihia A, Berthuy N, Calabrese A, Loven M, Saltuari L. Intrathecal baclofen therapy versus conventional medical management for severe poststroke spasticity: results from a multicentre, randomised, controlled, open-label trial (SISTERS). J Neurol Neurosurg Psychiatry. 2018 Jun;89(6):642-650. doi: 10.1136/jnnp-2017-317021. Epub 2018 Jan 11.

  PMID: 29326296 BACKGROUND

• Gracies JM, Brashear A, Jech R, McAllister P, Banach M, Valkovic P, Walker H, Marciniak C, Deltombe T, Skoromets A, Khatkova S, Edgley S, Gul F, Catus F, De Fer BB, Vilain C, Picaut P; International AbobotulinumtoxinA Adult Upper Limb Spasticity Study Group. Safety and efficacy of abobotulinumtoxinA for hemiparesis in adults with upper limb spasticity after stroke or traumatic brain injury: a double-blind randomised controlled trial. Lancet Neurol. 2015 Oct;14(10):992-1001. doi: 10.1016/S1474-4422(15)00216-1. Epub 2015 Aug 26.

  PMID: 26318836 BACKGROUND

• Riva N, Mora G, Soraru G, Lunetta C, Ferraro OE, Falzone Y, Leocani L, Fazio R, Comola M, Comi G; CANALS Study Group. Safety and efficacy of nabiximols on spasticity symptoms in patients with motor neuron disease (CANALS): a multicentre, double-blind, randomised, placebo-controlled, phase 2 trial. Lancet Neurol. 2019 Feb;18(2):155-164. doi: 10.1016/S1474-4422(18)30406-X. Epub 2018 Dec 13.

  PMID: 30554828 BACKGROUND

• Brashear A, Gordon MF, Elovic E, Kassicieh VD, Marciniak C, Do M, Lee CH, Jenkins S, Turkel C; Botox Post-Stroke Spasticity Study Group. Intramuscular injection of botulinum toxin for the treatment of wrist and finger spasticity after a stroke. N Engl J Med. 2002 Aug 8;347(6):395-400. doi: 10.1056/NEJMoa011892.

  PMID: 12167681 BACKGROUND

• de Freitas RM, Bhatia S, Sorensen E, Verma N, Carranza E, Ensel S, Borda L, Boos A, Goldsmith J, Fisher LE, Fields DP, Powell MP, Gordon S, Balzer J, Friedlander RM, Wittenberg GF, Gerszten PC, Krakauer JW, Pirondini E, Weber DJ, Capogrosso M. Spinal cord stimulation for upper limb motor function in people with chronic post-stroke hemiparesis: a feasibility trial. Nat Med. 2026 Jun 4. doi: 10.1038/s41591-026-04435-1. Online ahead of print.

  PMID: 42243548 BACKGROUND

• Lorach H, Galvez A, Spagnolo V, Martel F, Karakas S, Intering N, Vat M, Faivre O, Harte C, Komi S, Ravier J, Collin T, Coquoz L, Sakr I, Baaklini E, Hernandez-Charpak SD, Dumont G, Buschman R, Buse N, Denison T, van Nes I, Asboth L, Watrin A, Struber L, Sauter-Starace F, Langar L, Auboiroux V, Carda S, Chabardes S, Aksenova T, Demesmaeker R, Charvet G, Bloch J, Courtine G. Walking naturally after spinal cord injury using a brain-spine interface. Nature. 2023 Jun;618(7963):126-133. doi: 10.1038/s41586-023-06094-5. Epub 2023 May 24.

  PMID: 37225984 BACKGROUND

• Rowald A, Komi S, Demesmaeker R, Baaklini E, Hernandez-Charpak SD, Paoles E, Montanaro H, Cassara A, Becce F, Lloyd B, Newton T, Ravier J, Kinany N, D'Ercole M, Paley A, Hankov N, Varescon C, McCracken L, Vat M, Caban M, Watrin A, Jacquet C, Bole-Feysot L, Harte C, Lorach H, Galvez A, Tschopp M, Herrmann N, Wacker M, Geernaert L, Fodor I, Radevich V, Van Den Keybus K, Eberle G, Pralong E, Roulet M, Ledoux JB, Fornari E, Mandija S, Mattera L, Martuzzi R, Nazarian B, Benkler S, Callegari S, Greiner N, Fuhrer B, Froeling M, Buse N, Denison T, Buschman R, Wende C, Ganty D, Bakker J, Delattre V, Lambert H, Minassian K, van den Berg CAT, Kavounoudias A, Micera S, Van De Ville D, Barraud Q, Kurt E, Kuster N, Neufeld E, Capogrosso M, Asboth L, Wagner FB, Bloch J, Courtine G. Activity-dependent spinal cord neuromodulation rapidly restores trunk and leg motor functions after complete paralysis. Nat Med. 2022 Feb;28(2):260-271. doi: 10.1038/s41591-021-01663-5. Epub 2022 Feb 7.

  PMID: 35132264 BACKGROUND

• Francisco GE, McGuire JR. Poststroke spasticity management. Stroke. 2012 Nov;43(11):3132-6. doi: 10.1161/STROKEAHA.111.639831. Epub 2012 Sep 13. No abstract available.

  PMID: 22984012 BACKGROUND

MeSH Terms

Conditions

Muscle Spasticity; Stroke

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Jianguang Sun

CONTACT

010-60736388; sunjianguang@pinsmedical.com

Yifan Yang

CONTACT

15674915048; yangyifan@pinsmedical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2026
• First Posted: August 4, 2026
• Study Start: August 6, 2026
• Primary Completion (Estimated): February 15, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: August 4, 2026

Record last verified: 2026-07

Locations

CN (1)