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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bloodletting Puncture | Experimental | Bloodletting puncture at hand twelve jing-well points for 5 consecutive days, once a day, combined with conventional medical treatment. |
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| 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. |
|
| Control | No Intervention | Control group was treated with conventional medical treatment. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bloodletting Acupuncture | Other | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xijing Hospital | Xi'an | Shaanxi | 710032 | China | ||
| Xi'an TCM Hospital of Encephalopathy |
All data are available in the main text.
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| ID | Term |
|---|---|
| D004561 | Transcutaneous Electric Nerve Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
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| Transcutaneous electrical stimulation | Device | Transcutaneous electrical acupoint stimulation at hand twelve jing-well points. |
|
| 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. | 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. | baseline, immediately after the end of the first treatment |
| 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. | 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. | 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. | 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。 | from the first treatment to the end of the fifth treatment |
| Xi'an |
| Shaanxi |
| 710038 |
| China |
| Shaanxi Provincial People's Hospital | Xi'an | Shaanxi | 710068 | China |
| Xi'an International Medical Center Hospita | Xi'an | Shaanxi | 710100 | China |
| D000698 |
| Analgesia |
| D000760 | Anesthesia and Analgesia |