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

NCT06515132 | Recruiting DMC

• 1 other identifier: KY2024-752
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Disorder of Consciousness; Spinal Cord Stimulation

Keywords

Disorder of Consciousness; Spinal Cord Stimulation; Randomized clinical trail

Outcome Measures

Primary Outcomes (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).

  SCS stimulation for 3 months after operation

Secondary Outcomes (9)

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

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

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

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

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

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

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

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

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

  SCS stimulation for 3-month-postoperative-stimulation

Other Outcomes (2)

• Security outcome

  3 months after operation

• Security outcome

  3 months after operation

Study Arms (2)

SCS group

EXPERIMENTAL

SCS stimulation therapy is initiated 1 week post-surgery, which is administered continuously for a duration of 6 months.

Procedure: SCS Stimulation

Sham group

SHAM COMPARATOR

Sham 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.

Procedure: Sham Stimulation

Interventions

SCS Stimulation PROCEDURE

Participants will accept the SCS stimulus for six months

SCS group

Sham Stimulation PROCEDURE

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

Sham group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Huashan Hospital: lead
• Xiangya Hospital of Central South University: collaborator
• First Affiliated Hospital of Fujian Medical University: collaborator

Study Sites (3)

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, 350000, China

RECRUITING

Xiangya Hospital,Central South University

Changsha, Hunan, 410000, China

RECRUITING

Department of Neurosurgery, Huashan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

Related Publications (18)

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MeSH Terms

Conditions

Consciousness Disorders

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Xuehai Wu, Ph.D.

  Department of Neurosurgery, Huashan Hospital, Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xuehai Wu, Ph.D.

CONTACT

+8613764880571; Wuxuehai2013@163.com

Lijian Lang, M.M.

CONTACT

+8613896851367; lang_lijian@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This study is being conducted as a double-blind trial, wherein the surgeons, assessors and participants' family members are kept unaware of the assigned research groups. However, it is necessary to inform the physicians responsible for adjustment of stimulation parameters about the allocation of participants. Follow-up assessments of participants after stimulation will be conducted by an independent assessor using standardized evaluation criteria.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Director of Shanghai Neurosurgical Emergency Center

Study Record Dates

• First Submitted: June 23, 2024
• First Posted: July 23, 2024
• Study Start: January 10, 2025
• Primary Completion: December 30, 2025
• Study Completion (Estimated): May 30, 2026
• Last Updated: January 7, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)