Hand Jing-Well Points Stimulation to Treat Disorders of Consciousness (Wells-DoC)

Air Force Military Medical University of People's Liberation Army

Status: Enrolling

Conditions: Disorders of Consciousness Due to Severe Brain Injury

Treatments: Other: Bloodletting Acupuncture; Device: Transcutaneous electrical stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT06927713

KY20252094JIANGWEN

Details and patient eligibility

About

The purpose of this academic lead study is to explore the ideal stimulation strategies at Hand twelve jing-well points in patients with disorders of consciousness.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age: 18-80 years old
• From 7 to 90 days since brain injury
• Diagnosed in VS/UWS or MCS as defined by at least two CRS-R assessments performed during the screening period
• Acquired cerebral damage of known etiology
• Intact hand skin
• Informed consent given by the legal surrogate

Exclusion criteria

• Patients who continuously receive sedative drugs and Na+ or Ca2+ channel blockers (e.g., carbamazepine) or NMDA receptor antagonists (e.g., dextromethorphan)
• History of previous serious、progressive neurological disorder prior to the brian injury
• Epilepsy and seizure
• Unstable vital signs or life-threatening comorbidities
• Active implant (e.g., cardiac pacemakers/defibrillators, deep brain stimulators, ventriculoperitoneal shunt, etc)
• Documented pregnancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 3 patient groups

Bloodletting Puncture

Experimental group

Description:

Bloodletting puncture at hand twelve jing-well points for 5 consecutive days, once a day, combined with conventional medical treatment.

Treatment:

Other: Bloodletting Acupuncture

Transcutaneous electrical stimulation

Experimental group

Description:

Transcutaneous electrical acupoint stimulation at hand twelve jing-well points for 5 consecutive days, once a day, combined with conventional medical treatment.

Treatment:

Device: Transcutaneous electrical stimulation

Control

No Intervention group

Description:

Control group was treated with conventional medical treatment.