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Disorder of ConsciousnessSCORS-DOCNCT06515132

Efficacy and Safety of Spinal Cord Stimulation in Patients With Spinal Cord Stimulation

A study testing SCS Stimulation in people with Disorder of Consciousness and Spinal Cord Stimulation, run by Huashan Hospital at 3 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Investigating the efficacy and safety of spinal cord stimulation for patients with disorders of consciousness. Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
SCS Stimulation
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
50 participants
Where
3 sitesChina
Study dates
10 Jan 2025to 30 May 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male and female patients between the ages of 18 and 65, experiencing DOC for a duration ranging from 3 months to 1 year following brain disease.
  • Patients diagnosed with DOC as a consequence of traumatic brain injury, hypertensive intracerebral hemorrhage, or severe cerebral infarction.
  • Patients exhibiting stable cerebral anatomy and no need for further cranioplasty or hydrocephalus shunt.
  • Patients in MCS, who fulfill at least one of the following criteria: ① Demonstrating an oriented response to noxious stimuli; ② Exhibiting sustained eye tracking behavior; ③ Displaying purposeful movements; ④ Manifesting comprehension of language or emotions and actions (often observed in specific environments such as when hearing family members crying).
  • The vital signs and state of consciousness are stable: normal body temperature, the spontaneous breathing is stable (minimal sputum production and respiratory stability without oxygen supplementation for at least 2 hours); there is no significant change in the level of consciousness for at least 1 month and more.
  • Presence of short-latency responses (N20/P25) on somatosensory evoked potentials (SEP) recorded from the median nerve in the upper limbs.
  • Written informed consent obtained from legal guardians or representatives.

Who cannot join

  • Patients with a history of severe neurological or psychiatric disorders, or other significant diseases impacting prognosis prior to the onset of DOC;
  • Patients with contraindications for surgery, such as acute infections or coagulation disorders;
  • Patients who require short-wave diathermy treatment and are unable to undergo neurostimulation;
  • Patients with hypoxic brain injury due to suffocation, cardiac arrest, or respiratory arrest;
  • Patients with brainstem hemorrhage;
  • Pregnant women;
  • Patients who voluntarily request SCS implantation but are unwilling to cooperate with the research protocol;
  • Participants in other clinical trials.

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Xuehai Wu, Ph.D. contact

+8613764880571

Wuxuehai2013@163.com

Lijian Lang, M.M. contact

+8613896851367

lang_lijian@163.com

China3 sites, 3 recruiting

  • Xiangya Hospital,Central South University

    Changsha, Hunan, 410000

    Zhongyi Sun, Ph.D., 18163618671

    Recruiting

  • The First Affiliated Hospital of Fujian Medical University

    Fuzhou, Fujian, 350000

    Peisen Yao, Ph.D., 18650084102

    Recruiting

  • Department of Neurosurgery, Huashan Hospital, Fudan University

    Shanghai, Shanghai Municipality, 200000

    Xuehai Wu, Ph.D., +8613764880571, Wuxuehai2013@163.com

    Recruiting

Other trials in China

About this study

Official title: Efficacy and Safety of Spinal Cord Stimulation in Patients With Disorders of Consciousness: A Multicenter, Double-blind, Randomized Controlled Trail

Investigating the efficacy and safety of spinal cord stimulation for patients with disorders of consciousness.

Read the detailed description

Disorder of Consciousness (DOC) is a highly significant and concerning consequence that frequently ensues various acute brain injuries. The DOC encompasses coma, unresponsive wakefulness syndrome (UWS), also known as persistent vegetative state (PVS), and minimally conscious state (MCS). Currently, the available treatments for arousing patients with DOC are relatively limited, encompassing pharmacotherapy, hyperbaric oxygen therapy, neuromodulation, physical rehabilitation exercises, and traditional Chinese acupuncture. Among these approaches, only amantadine and transcranial direct current stimulation have demonstrated efficacy in DOC patients; however, further extensive validation is still warranted.

In recent years, spinal cord stimulation (SCS) has emerged as a cutting-edge and extensively researched modality for arousal therapy. SCS is a form of neuromodulation therapy primarily utilized for intractable pain, diabetic neuropathy, and muscle spasticity, the therapeutic efficacy of the SCS is both significant and safe. Although preliminary studies have demonstrated the potential of SCS in promoting arousal in patients with DOC, these findings are currently limited to small sample reports. Therefore, this multicenter randomized controlled trial aims to provide robust evidence on the effectiveness of SCS in promoting arousal among patients with DOC, thereby standardizing its clinical application and offering advanced evidence-based medicine for DOC management.

Being tested
SCS Stimulation, Sham Stimulation
Keywords
Disorder of Consciousness, Spinal Cord Stimulation, Randomized clinical trail
Medical subject headings
Consciousness Disorders

What participants receive

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

  • SCS StimulationProcedure or surgery

    Participants will accept the SCS stimulus for six months

  • Sham StimulationProcedure or surgery

    Sham stimulation will be performed in the first three months after surgery, and SCS stimulation will be started in the fourth month after surgery

Study groups in NCT06515132
Study groupRoleWhat they receive
SCS groupExperimentalSCS stimulation therapy is initiated 1 week post-surgery, which is administered continuously for a duration of 6 months.
Receives: Procedure: SCS Stimulation
Sham groupSham comparatorSham stimulation therapy is initiated 1 week post-surgery, and SCS stimulation therapy is initiated 3 months post-surgery, which is stimulated continuously for a duration of 3 months.
Receives: Procedure: Sham Stimulation

What is being measured

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

  1. Effective rate of awakening

    The CRS-R is employed, with a minimum of 5 CRS-R assessments conducted at each follow-up time point, accompanied by simultaneous video recording. And the highest value is scored as a state of consciousness. The clinical assessment of participants' consciousness is deemed significantly improved when it fulfills the following criteria: a) MCS- recover to consciousness level of MCS+ or higher; b) MCS status (MCS- or MCS+) recover to emergence from MCS (restoration of functional communication).

    Measured: SCS stimulation for 3 months after operation

Secondary outcomes (9)

  1. The difference of CRS-R scale relative to baseline between SCS group and Sham group

    The Coma Recovery Scale-Revised (CRS-R) is a standardized neurobehavioral assessment measure designed for use in patients with disorders of consciousness. It has good validity, reliability and practicability.

    Measured: SCS stimulation for 14 days, 1-month-postoperative-stimulation, 3-month-postoperative-stimulation, 6-month-postoperative-stimulation

  2. The difference of SECONDs scale relative to baseline between SCS group and Sham group

    The Simplified Evaluation of CONsciousness Disorders (SECONDs) is a fast tool to assess consciousness in brain-injured patients.

    Measured: SCS stimulation for 14 days, 1-month-postoperative-stimulation, 3-month-postoperative-stimulation, 6-month-postoperative-stimulation

  3. The difference of modified Ashworth scale relative to baseline between SCS group and Sham group

    The modified Ashworth scale is the most universally accepted clinical tool used to measure the increase of muscle tone.

    Measured: SCS stimulation for 14 days, 1-month-postoperative-stimulation, 3-month-postoperative-stimulation, 6-month-postoperative-stimulation

  4. The NCS-R scale relative to baseline between SCS group and Sham group

    The Nociception Coma Scale-Revised (NCS-R) was developed to help assess pain in patients with disorders of consciousness (DOC). Several studies have shown its sensitivity in assessing response to acute noxious stimuli.

    Measured: SCS stimulation for 14 days, 1-month-postoperative-stimulation, 3-month-postoperative-stimulation, 6-month-postoperative-stimulation

  5. The difference of effective rate of awakening between SCS group and Sham group by SECONDs scale

    Measured: SCS stimulation for 3-month-postoperative-stimulation

  6. SCS stimulation for 6-month-postoperative-stimulation, the difference of effective rate of awakening between SCS group and Sham group by CRS-R scale

    Measured: SCS stimulation for 6-month-postoperative-stimulation

  7. The difference of effective rate of awakening between SCS group and Sham group by SECONDs scale

    Measured: SCS stimulation for 6-month-postoperative-stimulation

  8. The difference of recovery trajectories of consciousness level between SCS group and Sham group

    Measured: SCS stimulation for 6-month-postoperative-stimulation

  9. The difference of effective rate of awakening of 3 month s of sham stimulation and 3 month s of SCS stimulation in Sham group

    Measured: 6-month-postoperation

Timeline

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

  1. First posted23 Jul 2024
  2. Study start10 Jan 2025 (estimated)
  3. Primary completion30 Dec 2025 (estimated)
  4. Study completion30 May 2026 (estimated)

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06515132
Sponsor's protocol ID
KY2024-752
Acronym
SCORS-DOC
Status last verified
Jan 2025
First submitted
23 Jun 2024
Last updated
7 Jan 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • van Erp WS, Lavrijsen JC, Vos PE, Bor H, Laureys S, Koopmans RT. The vegetative state: prevalence, misdiagnosis, and treatment limitations. J Am Med Dir Assoc. 2015 Jan;16(1):85.e9-85.e14. doi: 10.1016/j.jamda.2014.10.014.

    PubMed 25528282

  • Maas AIR, Menon DK, Manley GT, Abrams M, Akerlund C, Andelic N, Aries M, Bashford T, Bell MJ, Bodien YG, Brett BL, Buki A, Chesnut RM, Citerio G, Clark D, Clasby B, Cooper DJ, Czeiter E, Czosnyka M, Dams-O'Connor K, De Keyser V, Diaz-Arrastia R, Ercole A, van Essen TA, Falvey E, Ferguson AR, Figaji A, Fitzgerald M, Foreman B, Gantner D, Gao G, Giacino J, Gravesteijn B, Guiza F, Gupta D, Gurnell M, Haagsma JA, Hammond FM, Hawryluk G, Hutchinson P, van der Jagt M, Jain S, Jain S, Jiang JY, Kent H, Kolias A, Kompanje EJO, Lecky F, Lingsma HF, Maegele M, Majdan M, Markowitz A, McCrea M, Meyfroidt G, Mikolic A, Mondello S, Mukherjee P, Nelson D, Nelson LD, Newcombe V, Okonkwo D, Oresic M, Peul W, Pisica D, Polinder S, Ponsford J, Puybasset L, Raj R, Robba C, Roe C, Rosand J, Schueler P, Sharp DJ, Smielewski P, Stein MB, von Steinbuchel N, Stewart W, Steyerberg EW, Stocchetti N, Temkin N, Tenovuo O, Theadom A, Thomas I, Espin AT, Turgeon AF, Unterberg A, Van Praag D, van Veen E, Verheyden J, Vyvere TV, Wang KKW, Wiegers EJA, Williams WH, Wilson L, Wisniewski SR, Younsi A, Yue JK, Yuh EL, Zeiler FA, Zeldovich M, Zemek R; InTBIR Participants and Investigators. Traumatic brain injury: progress and challenges in prevention, clinical care, and research. Lancet Neurol. 2022 Nov;21(11):1004-1060. doi: 10.1016/S1474-4422(22)00309-X. Epub 2022 Sep 29.

    PubMed 36183712

  • Wu S, Wu B, Liu M, Chen Z, Wang W, Anderson CS, Sandercock P, Wang Y, Huang Y, Cui L, Pu C, Jia J, Zhang T, Liu X, Zhang S, Xie P, Fan D, Ji X, Wong KL, Wang L; China Stroke Study Collaboration. Stroke in China: advances and challenges in epidemiology, prevention, and management. Lancet Neurol. 2019 Apr;18(4):394-405. doi: 10.1016/S1474-4422(18)30500-3.

    PubMed 30878104

  • Multi-Society Task Force on PVS. Medical aspects of the persistent vegetative state (1). N Engl J Med. 1994 May 26;330(21):1499-508. doi: 10.1056/NEJM199405263302107.

    PubMed 7818633

  • Giacino JT, Ashwal S, Childs N, Cranford R, Jennett B, Katz DI, Kelly JP, Rosenberg JH, Whyte J, Zafonte RD, Zasler ND. The minimally conscious state: definition and diagnostic criteria. Neurology. 2002 Feb 12;58(3):349-53. doi: 10.1212/wnl.58.3.349.

    PubMed 11839831

  • Thibaut A, Bruno MA, Ledoux D, Demertzi A, Laureys S. tDCS in patients with disorders of consciousness: sham-controlled randomized double-blind study. Neurology. 2014 Apr 1;82(13):1112-8. doi: 10.1212/WNL.0000000000000260. Epub 2014 Feb 26.

    PubMed 24574549

  • Giacino JT, Whyte J, Bagiella E, Kalmar K, Childs N, Khademi A, Eifert B, Long D, Katz DI, Cho S, Yablon SA, Luther M, Hammond FM, Nordenbo A, Novak P, Mercer W, Maurer-Karattup P, Sherer M. Placebo-controlled trial of amantadine for severe traumatic brain injury. N Engl J Med. 2012 Mar 1;366(9):819-26. doi: 10.1056/NEJMoa1102609.

    PubMed 22375973

  • Denison T, Morrell MJ. Neuromodulation in 2035: The Neurology Future Forecasting Series. Neurology. 2022 Jan 11;98(2):65-72. doi: 10.1212/WNL.0000000000013061.

    PubMed 35263267

  • Petersen EA, Stauss TG, Scowcroft JA, Brooks ES, White JL, Sills SM, Amirdelfan K, Guirguis MN, Xu J, Yu C, Nairizi A, Patterson DG, Tsoulfas KC, Creamer MJ, Galan V, Bundschu RH, Paul CA, Mehta ND, Choi H, Sayed D, Lad SP, DiBenedetto DJ, Sethi KA, Goree JH, Bennett MT, Harrison NJ, Israel AF, Chang P, Wu PW, Gekht G, Argoff CE, Nasr CE, Taylor RS, Subbaroyan J, Gliner BE, Caraway DL, Mekhail NA. Effect of High-frequency (10-kHz) Spinal Cord Stimulation in Patients With Painful Diabetic Neuropathy: A Randomized Clinical Trial. JAMA Neurol. 2021 Jun 1;78(6):687-698. doi: 10.1001/jamaneurol.2021.0538.

    PubMed 33818600

  • Hara S, Andresen H, Solheim O, Carlsen SM, Sundstrom T, Lonne G, Lonne VV, Taraldsen K, Tronvik EA, Oie LR, Gulati AM, Sagberg LM, Jakola AS, Solberg TK, Nygaard OP, Salvesen OO, Gulati S. Effect of Spinal Cord Burst Stimulation vs Placebo Stimulation on Disability in Patients With Chronic Radicular Pain After Lumbar Spine Surgery: A Randomized Clinical Trial. JAMA. 2022 Oct 18;328(15):1506-1514. doi: 10.1001/jama.2022.18231.

    PubMed 36255427

  • Mekhail N, Levy RM, Deer TR, Kapural L, Li S, Amirdelfan K, Hunter CW, Rosen SM, Costandi SJ, Falowski SM, Burgher AH, Pope JE, Gilmore CA, Qureshi FA, Staats PS, Scowcroft J, Carlson J, Kim CK, Yang MI, Stauss T, Poree L; Evoke Study Group. Long-term safety and efficacy of closed-loop spinal cord stimulation to treat chronic back and leg pain (Evoke): a double-blind, randomised, controlled trial. Lancet Neurol. 2020 Feb;19(2):123-134. doi: 10.1016/S1474-4422(19)30414-4. Epub 2019 Dec 20.

    PubMed 31870766

  • North RB, Kidd DH, Zahurak M, James CS, Long DM. Spinal cord stimulation for chronic, intractable pain: experience over two decades. Neurosurgery. 1993 Mar;32(3):384-94; discussion 394-5. doi: 10.1227/00006123-199303000-00008.

    PubMed 8455763

  • Funahashi K, Komai N, Ogura M, Kuwata T, Nakai M, Tsuji N. [Effects and indications of spinal cord stimulation on the vegetative syndrome]. No Shinkei Geka. 1989 Oct;17(10):917-23. Japanese.

    PubMed 2812256

  • Kanno T, Morita I, Yamaguchi S, Yokoyama T, Kamei Y, Anil SM, Karagiozov KL. Dorsal column stimulation in persistent vegetative state. Neuromodulation. 2009 Jan;12(1):33-8. doi: 10.1111/j.1525-1403.2009.00185.x.

    PubMed 22151220

  • Piedade GS, Assumpcao de Monaco B, Guest JD, Cordeiro JG. Review of spinal cord stimulation for disorders of consciousness. Curr Opin Neurol. 2023 Dec 1;36(6):507-515. doi: 10.1097/WCO.0000000000001222. Epub 2023 Oct 26.

    PubMed 37889524

Questions about this trial

What is this clinical trial studying?

A study testing SCS Stimulation in people with Disorder of Consciousness and Spinal Cord Stimulation, run by Huashan Hospital at 3 sites in China.

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 7 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: looking for participants now, as of the sponsor's last update on 7 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in China. 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. Some participants in this study may receive a placebo. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Xuehai Wu, Ph.D. (+8613764880571, Wuxuehai2013@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Effective rate of awakening (time frame: SCS stimulation for 3 months after operation). 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 NCT06515132, which also lists 18 linked publications.

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 7 Jan 2025.

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