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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
60
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).
Transcutaneous electrical acupoint stimulation at hand twelve jing-well points.
Xijing Hospital
Xi'an, Shaanxi, China
RECRUITINGComa Recovery Scale-Revised (CRS-R) change
CRS-R score ranges from 0 to 23, with higher scores mean a better outcome.
Time frame: baseline, immediately after the end of the 5-day treatment
ABCD model change
This model classifies the power spectrum of resting-state EEG data into four categories: A, B, C, and D. Type A exhibits a power spectrum peak in the delta range (0-4 Hz), indicative of a completely disconnected thalamocortical network. Type B shows a primary power spectrum peak in the theta range (4-8 Hz), reflecting a severely disconnected thalamocortical network. Type C exhibits power spectrum peaks in both the theta (4-8 Hz) and beta (13-24 Hz) ranges, indicative of a moderately disconnected thalamocortical network. Type D shows power spectrum peaks in the alpha (8-13 Hz) and beta ranges, representing a fully intact thalamocortical network.
Time frame: baseline, immediately after the end of the 5-day treatment
ABCD model change
This model classifies the power spectrum of resting-state EEG data into four categories: A, B, C, and D. Type A exhibits a power spectrum peak in the delta range (0-4 Hz), indicative of a completely disconnected thalamocortical network. Type B shows a primary power spectrum peak in the theta range (4-8 Hz), reflecting a severely disconnected thalamocortical network. Type C exhibits power spectrum peaks in both the theta (4-8 Hz) and beta (13-24 Hz) ranges, indicative of a moderately disconnected thalamocortical network. Type D shows power spectrum peaks in the alpha (8-13 Hz) and beta ranges, representing a fully intact thalamocortical network.
Time frame: baseline, immediately after the end of the first treatment
Coma Recovery Scale-Revised (CRS-R) change
CRS-R score ranges from 0 to 23, with higher scores mean a better outcome.
Time frame: baseline, immediately after the end of the first treatment
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Glasgow Outcome Scale-Extended (GOSE)
A GOSE score of 1 indicates death, 2 indicates a vegetative state, 3 to 4 indicates severe disability, 5 to 6 indicates moderate disability, and 7 to 8 indicates good recovery. Favorable functional outcome is defined as an GOSE score of 4-8, while unfavorable functional outcome is defined as an GOSE score of 1-3.
Time frame: at six months post enrollment
Consciousness level change
The level of consciousness was evaluated using CRS-R score. Patients who transitioned from UWS to MCS (UWS-MCS) or to emergence from MCS (EMCS) (UWS-EMCS), from MCS minus to MCS plus (MCS - -MCS + ) or to EMCS (MCS - -EMCS), and from MCS to EMCS (MCS-EMCS) were categorized in the improved consciousness group. The unimproved consciousness was defined as a reduced or unchanged level of consciousness.
Time frame: baseline, at six months post enrollment
Correlation between EEG responsiveness and long-term outcomes
EEG responsiveness to the treatment was considered positive if, after the hand Jing-Well points stimulation, patients exhibited elevated levels of EEG "ABCD" patterns compared to the baseline after either the first or fifth stimulation session. The correlation between EEG responsiveness and long-term consciousness improvement and favorable functional outcome was assessed.
Time frame: on the first day, the fifth day and at six months post enrollment
Incidence of Adverse Events
The incidence of adverse events occurred during the intervention period, including treatment intolerance：painful facial expressions, moans, crying, and head movements；Local adverse effect：skin infections (redness, swelling, suppuration), subcutaneous ecchymosis, skin burns (blisters or eschar formation)；Systemic adverse effect：epileptic seizures。
Time frame: from the first treatment to the end of the fifth treatment