Transcutaneous Electrical Acupoint Stimulation at Jing-Well Points for Disorders of Consciousness
Recruiting
Phase 2
Phase 3
Interventional Study
Disorders of Consciousness Due to Severe Brain Injury
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 80
- Sex
- Any
- Trial phase
- Phase 2/3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 160 (estimated)
- Sponsor
- Xijing Hospital · Other
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About This Trial
Effective treatment options for disorders of consciousness (DoC) remain limited, and available interventions show heterogeneous efficacy. To date, limited evidences support the use of amantadine and transcranial direct current stimulation in this population.
Bloodletting puncture (BP) at the hand twelve Jing-Well points (HTWPs) has been traditionally used in China as an empirical therapy for DoC;…
Trial Locations
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Eligibility Criteria
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 su…
Contacts