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NCT Number: NCT05922644

Short-term Cervical Spinal Cord Stimulation in Patients With Disorders of Consciousness After Intracerebral Hemorrhage

Disorders of consciousness (DOC) refers to the persistent loss of consciousness after 28 days in patients with brain injury caused by trauma, stroke, or hypoxia. It includes coma, vegetative state, and minimally conscious state. At present, there is no effective treatment for DOC. Only one RCT study of amantadine has proved that it may be effective for the treatment of DOC. In recent years, more evidence has shown that neuromodulation technology is beneficial to the recovery of DOC. Cervical spinal cord stimulation surgery is a new treatment method for patients with DOC. Electrodes are implanted in the high cervical spinal cord C2-C5. By adjusting different electrical stimulation parameters, it has a wake-promoting effect. In this study, patients were selected into the spinal cord stimulation group and the conventional treatment group according to the wishes of their families. The patients in the spinal cord stimulation group were given 21 days of cervical spinal cord stimulation treatment on the basis of conventional brain rehabilitation. Patients were followed up routinely and completed designated examinations at 12 months to determine the safety and efficacy of cervical spinal cord stimulation therapy.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100050, China

Location status: Recruiting

Location contact

Yong Cao, M.D.

CONTACT

[email protected]

010-67096523 ext. 100050

Yong Cao, M.D.

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age between 18 and 65 years old
  • Patients with postoperative consciousness disorders after cerebral hemorrhage for more than 28 days
  • CRS-R score meets the MCS diagnosis
  • Signed informed consent.

Exclusion criteria

  • Secondary brain injury caused by arteriovenous malformation, cerebral aneurysm, cavernous hemangioma, brain tumor and carbon monoxide poisoning
  • History of previous epileptic seizures
  • Critical condition, unstable intracranial condition, risk of rebleeding
  • Unstable vital signs requiring mechanical ventilation
  • Contraindications for spinal cord surgery
  • Severe sympathetic overactivity syndrome.

Treatment and study plan

SCS

Device

21 days of cervical spinal cord electrical stimulation treatment in addition to routine brain resuscitation and rehabilitation awakening treatment.

Conventional

Other

Routine brain resuscitation and rehabilitation awakening treatment.

Primary outcomes

  1. Change in consciousness 12 months after surgery assessed by CRS-R

    Time frame: 12 months

    The primary efficacy indicator is "change in consciousness recovery 12 months after cervical spinal cord electrical stimulation (assessed by the Coma Recovery Scale - Revised (CRS-R), ranges from 0 to 25, with higher scores mean a better outcome)".

Secondary outcomes

  1. Consciousness recovery 12 months after surgery assessed by GOS-E

    Time frame: 12 months

    The secondary efficacy indicator is "consciousness recovery 12 months after surgery (assessed by the Glasgow Outcome Scale - Extended (GOS-E) to evaluate the patient's consciousness status, ranges from 0 to 8, with higher scores mean a better outcome)".

Other outcomes

  1. Glasgow Coma Scale (GCS)

    Time frame: 12 months

    Exploratory Indicators, ranges from 0 to 15, with higher scores mean a better outcome.

  2. National Institute of Health stroke scale (NIHSS)

    Time frame: 12 months

    Exploratory Indicators, ranges from 0 to 42, with higher scores mean a worse outcome.

  3. Full Outline of UnResponsiveness (FOUR) Score

    Time frame: 12 months

    Exploratory Indicators, ranges from 0 to 16, with higher scores mean a better outcome.

  4. Disability rating scale (DRS)

    Time frame: 12 months

    Exploratory Indicators, ranges from 0 to 29, with higher scores mean a worse outcome.

Study contacts

Contact information is provided by the study sponsor or research team.

Qiheng He, MD

CONTACT

[email protected]

+8615699952258

Yong Cao, MD

CONTACT

[email protected]

+8613601362306

Sponsors and collaborators

Lead sponsor

Beijing Tiantan Hospital

Other

Collaborators

  • Rehabilitation Hospital Affiliated to National Research Center for Rehabilitation Technical Aids
  • Shenzhen Nanshan District Shekou People's Hospital

Registry information

Official study title

The Safety and Efficacy of Short-term Cervical Spinal Cord Stimulation in Patients With Disorders of Consciousness After Intracerebral Hemorrhage: a Multicenter, Prospective, Randomized, Outcome-blind Interventional Study

Acronym: SCS-ICH

Important dates

Study start
2023
Primary completion
2026
Study completion
2030
First posted
Jun 28, 2023
Registry last updated
Jul 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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