Intervention Effect of Transcranial Alternating Current Stimulation (tACS) on Disorder of Consciousness (DOC)

Disorders of Consciousness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06076733
• Other study ID #: AHMU-tACS-DOC
• Status: Recruiting
• Phase: N/A
• Start date: September 21, 2023
• Est. completion date: September 20, 2025

Study information

• Verified date: October 2023
• Source: Anhui Medical University
• Contact: Kai Wang, PhD
• Phone: +86-0551-62923704
• Email: wangkai1964[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Forty patients with chronic consciousness disorder who met the inclusion criteria were recruited with the informed consent of the family. All the participants were randomized to receive "active" or "sham" treatment protocol. Stimulation was performed using a alternating stimulator linked to one anodal electrode and four cathodal electrodes. The anodal electrode was placed over the left dorsolateral prefrontal cortex (DLPFC; F3 in the 10-20 international system of EEG placement), and the four cathodal electrodes (AFz, FCz, F7, and C5 in the 10-20 international system EEG placement) were placed around the anodal electrode to form a current loop. Twenty 2 milliampere (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 6 Hertz (Hz). 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. Before and after the tACS treatment, the state of consciousness was assessed according to coma recovery scale-revised(CRS-R), and19-channel EEG data were collected.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: September 20, 2025
• Est. primary completion date: September 20, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. patients diagnosed as chronic disorders of consciousness based on CRS-R assessment by at least two professional neurologists;

2. the age requirement is between 18 and 75;

3. vital signs need to be stable;

4. no neuromuscular blockers and sedatives have been used within 24 hours before the study and the entire protocol;

5. no improvement in the state of consciousness was observed within one week before the start of the study.

Exclusion Criteria:

1. previous or current diagnosis of severe neurocognitive degenerative diseases;

2. metal implantation in the head;

3. previous surgical procedures resulted in skull defect;

4. previous history of epilepsy.

Related Conditions & MeSH terms

• Consciousness Disorders
• Disorders of Consciousness

Intervention

Device:
• high definition-transcranial alternating current stimulation
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 transcranial alternating current stimulation
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.

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Anhui Medical University	Hefei	Anhui

Sponsors (1)

Lead Sponsor	Collaborator
Anhui Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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