Intervention Effect of Transcranial Alternating Current Stimulation (tACS) on Disorder of Consciousness (DOC)
To Explore the Intervention Effect of High Definition-transcranial Alternating Current Stimulation (HD-tACS) on Consciousness Promotion in Patients With Chronic Consciousness Disorders and the Potential Neural Mechanism
1 other identifier
interventional
40
1 country
1
Brief Summary
To investigate the effect of high definition-transcranial alternating current stimulation(HD-tACS) on consciousness promotion in patients with chronic consciousness disorders and the underlying neural mechanism by EEG.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 21, 2023
CompletedFirst Submitted
Initial submission to the registry
October 2, 2023
CompletedFirst Posted
Study publicly available on registry
October 11, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 20, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 20, 2025
CompletedOctober 12, 2023
October 1, 2023
2 years
October 2, 2023
October 11, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Assessment of Coma Recovery Scale
State of consciousness was assessed by two trained physicians in three different time periods using the Coma Recovery Scale-Revised (CRS-R), which has demonstrated good reliability and validity for the behavioral evaluation of disorder of consciousness (DOC) patients. Total score ranges from zero to twenty-three, with higher scores indicating better neurological function and prognosis.
Before intervention and one day after all intervention
Study Arms (2)
active group
EXPERIMENTALTwenty 2-mA sessions (ramp-up and ramp-down periods of 30 and 30 seconds, respectively) were applied for 20 minutes per session, twice daily over 10 consecutive days, and the stimulus frequency was set as 6Hz.
sham group
SHAM COMPARATORSham tACS was delivered using the same protocol and current intensity, but the period of active stimulation was only during the ramp-up and ramp-down periods of 30 and 30 seconds.
Interventions
tACS is described as a non-invasive form of brain stimulation that uses a low-intensity, alternating current applied directly to the head through scalp electrodes.
Sham tACS was delivered using the same protocol and current intensity, but the period of active stimulation was only during the ramp-up and ramp-down periods of 30 and 30 seconds.
Eligibility Criteria
You may qualify if:
- patients diagnosed as chronic disorders of consciousness based on CRS-R assessment by at least two professional neurologists;
- the age requirement is between 18 and 75;
- vital signs need to be stable;
- no neuromuscular blockers and sedatives have been used within 24 hours before the study and the entire protocol;
- no improvement in the state of consciousness was observed within one week before the start of the study.
You may not qualify if:
- previous or current diagnosis of severe neurocognitive degenerative diseases;
- metal implantation in the head;
- previous surgical procedures resulted in skull defect;
- previous history of epilepsy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kai Wang, PhD
Director of medical psychological department, Anhui Medical University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of medical psychological department, Anhui Medical University
Study Record Dates
First Submitted
October 2, 2023
First Posted
October 11, 2023
Study Start
September 21, 2023
Primary Completion
September 20, 2025
Study Completion
September 20, 2025
Last Updated
October 12, 2023
Record last verified: 2023-10