Disorders of Consciousness Due to Severe Brain Injury
Conditions
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.
Interventions
OTHERBloodletting Acupuncture
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).
DEVICETranscutaneous electrical stimulation
Transcutaneous electrical acupoint stimulation at hand twelve jing-well points.
Sponsors
Xijing Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Coma Recovery Scale-Revised (CRS-R) change | baseline, immediately after the end of the 5-day treatment | CRS-R score ranges from 0 to 23, with higher scores mean a better outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ABCD model change | baseline, immediately after the end of the 5-day treatment | 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. |
| Coma Recovery Scale-Revised (CRS-R) change | baseline, immediately after the end of the first treatment | CRS-R score ranges from 0 to 23, with higher scores mean a better outcome. |
| Glasgow Outcome Scale-Extended (GOSE) | at six months post enrollment | 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. |
| Consciousness level change | baseline, at six months post enrollment | 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. |
| Correlation between EEG responsiveness and long-term outcomes | on the first day, the fifth day and at six months post enrollment | 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. |
| Incidence of Adverse Events | from the first treatment to the end of the fifth treatment | 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。 |
Countries
China
Outcome results
None listed