Transcutaneous Electrical Acupoint Stimulation at Jing-Well Points for Disorders of Consciousness
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorXijing Hospital
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; however, its efficacy has not been established by robust clinical evidence. Transcutaneous electrical acupoint stimulation (TEAS) provides a modern, noninvasive alternative for acupoint stimulation. The Wells-DoC trial, a multicenter, randomized, controlled, open-label study with blinded endpoint assessment, provided preliminary evidence that TEAS applied at the hand twelve Jing-Well points was associated with a numerically higher proportion of consciousness improvement in patients with DoC, although the difference did not reach statistical significance. These findings support the need for further evaluation in an adequately powered randomized controlled trial.
The Wells-DoC II trial is a multicenter, randomized, controlled, double-blind clinical trial designed to evaluate the efficacy and safety of TEAS at the twelve Jing-Well points of the hand in patients with DoC. The primary objective of the Wells-DoC II trial is to determine whether TEAS applied at the twelve Jing-Well points of the hand improves consciousness in adults with DoC. The primary endpoint is the proportion of patients achieving consciousness improvement after 14 consecutive days of treatment, compared between the TEAS group and the sham stimulation (placebo control) group.
The secondary objectives are to assess the effects of TEAS versus sham stimulation on: (1) changes in Coma Recovery Scale-Revised (CRS-R) scores at 7 and 14 days; (2) change in ABCD model classification at day 14; and (3) functional outcomes measured by the Glasgow Outcome Scale-Extended (GOSE) at 3 and 6 months after enrollment.
A total of 160 patients will be recruited over a 28-month period.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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 brain injury;
Epilepsy and seizure
Unstable vital signs or life-threatening comorbidities
Trial design
Design model
Parallel
Treatments tested in this trial
Transcutaneous electrical stimulation
DeviceTranscutaneous electrical acupoint stimulation at hand twelve jing-well points
Sham electrical stimulation
DeviceSham electrical acupoint stimulation at hand twelve jing-well points
Treatment groups
160 Participants
are divided into 2 treatment groupsGroup A: Transcutaneous electrical stimulation groupExperimental treatment 1 intervention
Group B: Sham electrical stimulation groupSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Proportion of consciousness improvement after 14 consecutive days of treatment
The primary effectiveness outcome was the proportion of patients with consciousness improvement after 14 consecutive days of treatment, wherein improvements from unresponsive wakefulness syndrome (UWS)/vegetative state (VS) to minimally conscious state (MCS) or emergence from minimally conscious state (EMCS), from MCS minus (MCS-) to MCS plus (MCS+) or EMCS, or from MCS+ to EMCS signify a consciousness improvement. Diagnoses of UWS/VS, MCS (minus or plus) and EMCS were determined based on the presence of specific Coma Recovery Scale-Revised (CRS-R) subscale items, assessed by a trained neurologist. The hierarchical order of consciousness levels from worst to best is UWS/VS, MCS-, MCS+, and EMCS.
Time frame
14 days after treatmentSecondary outcomes
1
Changes in Coma Recovery Scale-Revised (CRS-R) scores after 7 days of treatment
CRS-R is composed of six subscales: auditory function, visual function, motor function, oromotor function, communication ability, and arousal level. CRS-R score ranges from 0 to 23, with higher scores mean a better outcome.
Time frame
7 days after treatment2
Changes in sub scale of Coma Recovery Scale-Revised (CRS-R) scores after 7 days of treatment
CRS-R is composed of six subscales: auditory function, visual function, motor function, oromotor function, communication ability, and arousal level. CRS-R score ranges from 0 to 23, with higher scores mean a better outcome. Each sub scale consists of multiple hierarchically organized questions, with higher scores indicating greater performance.
Time frame
7 days after treatment3
Changes in Coma Recovery Scale-Revised (CRS-R) scores after 14 days of treatment
CRS-R is composed of six subscales: auditory function, visual function, motor function, oromotor function, communication ability, and arousal level. CRS-R score ranges from 0 to 23, with higher scores mean a better outcome.
Time frame
14 days after treatment4
Changes in sub scale of Coma Recovery Scale-Revised (CRS-R) scores after 14 days of treatment
CRS-R is composed of six subscales: auditory function, visual function, motor function, oromotor function, communication ability, and arousal level. CRS-R score ranges from 0 to 23, with higher scores mean a better outcome. Each sub scale consists of multiple hierarchically organized questions, with higher scores indicating greater performance.
Time frame
14 days after treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov