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

Primary Purpose

Disorders of Consciousness

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
high definition-transcranial alternating current stimulation
sham transcranial alternating current stimulation
Sponsored by
Anhui Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Disorders of Consciousness focused on measuring DOC tACS

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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.

Sites / Locations

  • The First Affiliated Hospital of Anhui Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

active group

sham group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
October 2, 2023
Last Updated
October 11, 2023
Sponsor
Anhui Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT06076733
Brief Title
Intervention Effect of Transcranial Alternating Current Stimulation (tACS) on Disorder of Consciousness (DOC)
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 21, 2023 (Actual)
Primary Completion Date
September 20, 2025 (Anticipated)
Study Completion Date
September 20, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Anhui Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Disorders of Consciousness
Keywords
DOC tACS

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
active group
Arm Type
Experimental
Arm Description
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.
Arm Title
sham group
Arm Type
Sham Comparator
Arm Description
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
Intervention Name(s)
high definition-transcranial alternating current stimulation
Intervention Description
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
Intervention Name(s)
sham transcranial alternating current stimulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Assessment of Coma Recovery Scale
Description
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.
Time Frame
Before intervention and one day after all intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kai Wang, PhD
Phone
+86-0551-62923704
Email
wangkai1964@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Chen Chen
Phone
+8618225855669
Email
18225855669@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kai Wang, PhD
Organizational Affiliation
Director of medical psychological department, Anhui Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Affiliated Hospital of Anhui Medical University
City
Hefei
State/Province
Anhui
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chen Chen
Phone
+8618225855669
Email
18225855669@163.com

12. IPD Sharing Statement

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

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