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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-21

Study Completion Date

2025-09-20

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Disorders of Consciousness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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active group

Twenty 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.

Group Type EXPERIMENTAL

high definition-transcranial alternating current stimulation

Intervention Type DEVICE

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 group

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.

Group Type SHAM_COMPARATOR

sham transcranial alternating current stimulation

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

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.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No