NCT06927713

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
7mo left

Started May 2025

Geographic Reach
1 country

4 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress64%
May 2025Nov 2026

First Submitted

Initial submission to the registry

March 30, 2025

Completed
16 days until next milestone

First Posted

Study publicly available on registry

April 15, 2025

Completed
27 days until next milestone

Study Start

First participant enrolled

May 12, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 26, 2025

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2026

Expected
Last Updated

February 18, 2026

Status Verified

May 1, 2025

Enrollment Period

8 months

First QC Date

March 30, 2025

Last Update Submit

February 13, 2026

Conditions

Disorders of Consciousness Due to Severe Brain Injury

Outcome Measures

Primary Outcomes (1)

  • Coma Recovery Scale-Revised (CRS-R) change

    CRS-R score ranges from 0 to 23, with higher scores mean a better outcome.

    baseline, immediately after the end of the 5-day treatment

Secondary Outcomes (7)

  • ABCD model change

    baseline, immediately after the end of the 5-day treatment

  • ABCD model change

    baseline, immediately after the end of the first treatment

  • Coma Recovery Scale-Revised (CRS-R) change

    baseline, immediately after the end of the first treatment

  • Glasgow Outcome Scale-Extended (GOSE)

    at six months post enrollment

  • Consciousness level change

    baseline, at six months post enrollment

  • +2 more secondary outcomes

Study Arms (3)

Bloodletting Puncture

EXPERIMENTAL

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

Other: Bloodletting Acupuncture

Transcutaneous electrical stimulation

EXPERIMENTAL

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

Device: Transcutaneous electrical stimulation

Control

NO INTERVENTION

Control group was treated with conventional medical treatment.

Interventions

Bloodletting AcupunctureOTHER

Bloodletting was applied to the right hand first and then the left hand in the order of Shaoshang (LU 11), Shangyang (LI 1), Zhongchong (PC 9), Guanchong (TE 1), Shaochong (HT 9) and Shaoze (SI 1).

Bloodletting Puncture
Transcutaneous electrical stimulationDEVICE

Transcutaneous electrical acupoint stimulation at hand twelve jing-well points.

Transcutaneous electrical stimulation

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Xijing Hospital

Xi'an, Shaanxi, 710032, China

Location

Xi'an TCM Hospital of Encephalopathy

Xi'an, Shaanxi, 710038, China

Location

Shaanxi Provincial People's Hospital

Xi'an, Shaanxi, 710068, China

Location

Xi'an International Medical Center Hospita

Xi'an, Shaanxi, 710100, China

Location

MeSH Terms

Interventions

Transcutaneous Electric Nerve Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsPhysical Therapy ModalitiesRehabilitationAnalgesiaAnesthesia and Analgesia

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2025

First Posted

April 15, 2025

Study Start

May 12, 2025

Primary Completion

December 26, 2025

Study Completion (Estimated)

November 30, 2026

Last Updated

February 18, 2026

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will share

All data are available in the main text.

Shared Documents
STUDY PROTOCOL, SAP

Locations

CN(4)