Transcranial Alternating Current Stimulation in Patients With Disorders of Consciousness

January 8, 2024 updated by: First Affiliated Hospital of Zhejiang University

Clinical Study on Efficacy and Mechanism of HD-tACS in Patients With Prolonged Disorders of Consciousness

In recent years, many literatures have reported that tACS, as a non-invasive electrical brain stimulation technique, has been applied in depression, schizophrenia, dementia and other fields.

The goal of this study is to explore the clinical efficacy and mechanism of action of HD-tACS in patients with chronic disorders of consciousness.The main questions it aims to answer are:

  1. Explore the neurophysiological effects of HD-tACS on patients with chronic disorders of consciousness under theta and gamma frequency stimulation, and observe its impact on behavioral changes and long-term prognosis;
  2. Further investigate the awakening mechanism of consciousness disorders through HD-tACS stimulation using multimodal assessment;
  3. Clarify the role of theta and gamma neural oscillations in consciousness disorders, providing new targets for the pathogenesis and treatment of Disorders of Consciousness .

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Background: tACS is a transcranial nerve regulation technique ,it has been applied in depression, schizophrenia, dementia and other fields. However, the exact mechanism of tACS has not been fully elucidated, and there are few reports about the effect of tACS stimulation on patients with consciousness disorder at home and abroad.

Objective: The study aimed to investigate the reactivity of electroencephalography (EEG) and the clinical response of patients with disorders of consciousness and explore the neuromodulatory effects of HD-tACS in patients with chronic disorders of consciousness.

Method: Based on inclusion and exclusion criteria, patients with disorders of consciousness are categorized into chronic coma, vegetative state (VS), and minimally conscious state (MCS) groups. General and clinical data of the patients are collected. Assessments using the CRS-R scale and resting-state EEG are conducted before and after the trial. The trial is designed as a randomized controlled experiment, divided into an HD-tACS real stimulation group and a sham stimulation group. In the real stimulation group, different frequencies (40Hz gamma, 4Hz theta) of stimulation are applied to the left dorsolateral prefrontal cortex, with a current intensity of 2mA for 20 minutes per day, continuously for 5 days. In the sham stimulation group, the tACS stimulation mode and frequency are consistent with the real stimulation group, but current is only passed during the first and last 30 seconds of the entire 20-minute stimulation period. EEG is collected for all patients before stimulation, on the first day of stimulation, and after the stimulation ends. Follow-ups include CRS-R scale and GOS-E scores after 3 months and GOS-E scores after 6 months.

Study Type

Interventional

Enrollment (Estimated)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310000
        • Recruiting
        • The First Affiliated Hospital of Zhejiang University
        • Principal Investigator:
          • Benyan Luo, Phd
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 1. Patients with consciousness disorders for more than 28 days following severe brain injury, assessed by the CRS-R scale to meet the criteria for VS or MCS; 2. Aged between 14 and 80 years; 3. Stable vital signs; 4. No neuromuscular function blockers and no sedation within the prior 24 hours;

Exclusion Criteria:

  • 1. Locked-in syndrome; 2. Contraindications for EEG examination;HD-tACS stimulation. 3. Contraindications for MRI scanning, such as the presence of internal metallic implants; 4. Diseases and factors that may affect brain function assessment, such as metabolic disorders, poisoning, shock, etc.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Transcranial electrical stimulation HD-tES
real HD-tACS:anodal transcranial alternating current stimulation were delivered over the left DLPF cortex for patients in different frequencies (40Hz gamma, 4Hz theta) , with a current intensity of 2mA for 20 minutes per day.
Device: real transcranial alternating current stimulation
The alternating current was non-invasively delivered using an M×N five-channel high-definition transcranial electrical current stimulator (Soterix Medical). A BrainCap (Brain Vision) embedded with high-definition plastic holders consisted of five 12-mm-diameter Ag/AgCl ring electrodes, filled with conductive gel. During real HD-tACS, the current was increased to 2 mA from the onset of stimulation and applied for 20 minutes.
Sham Comparator: sham Transcranial electrical stimulation HD-tES
sham HD-tACS: sham transcranial alternating current stimulation were delivered over the left DLPF cortex for patients in different frequencies (40Hz gamma, 4Hz theta) , with a current intensity of 2mA for 20 minutes per day.
Device: sham transcranial alternating current stimulation
For the sham condition(sham HD-tACS), the same electrode placement was used as in the stimulation condition, but the current was only applied during the first and last 30 seconds of the entire 20-minute stimulation period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the JFK Coma Recovery Scale-Revised (CRS-R) scale
Time Frame: at baseline (T0), immediately after the end of the treatment (T1), 5 days later (T2).Investigators observed the changes from baseline to the end of stimulation
The primary outcome measure is the change in the CRS-R scale in patients with prolonged Disorders of Consciousness (pDoC) after 5 days of HD-tACS treatment.The CRS-R is a tool used to characterise the level of consciousness.The CRS-R is a tool used to characterize the level of consciousness and to monitor neurobehavioural recovery in DOC. The scale consists of 23 hierarchically arranged items that comprise six subscales addressing the auditory, visual, motor, oromotor/verbal, communication and arousal processes. The lowest item on each subscale represents reflexive activity whereas the highest item represents cognitively mediated behaviors
at baseline (T0), immediately after the end of the treatment (T1), 5 days later (T2).Investigators observed the changes from baseline to the end of stimulation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
EEG data ( electrophysiological parameters)
Time Frame: at baseline (T0), immediately after the end of the treatment (T1), 5 days later (T2)
delta (1-4 Hz), theta (4-8 Hz), alpha (8-12 Hz) and beta (12-30 Hz).an increase of delta and theta activity usually reflects encephalopathy and/or structural lesions, interpreted as poor outcome predictor of DOC .The power of α and β is related to the chance of recovery.
at baseline (T0), immediately after the end of the treatment (T1), 5 days later (T2)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glasgow Outcome Scale-Extended (GOS-E)
Time Frame: In the first and third months after the stimulus ends
GOS-E is an extended version of the Glasgow Outcome Scale (GOS), which was developed to provide a more detailed assessment of patient functionality and quality of life after experiencing brain injury. It has eight categories:Dead, Vegetative State, Lower Severe Disability, Upper Severe Disability, Lower Moderate Disability, Upper ModerateDisability, Lower Good Recovery, and Upper Good Recovery.Percentage of patients with improved consciousness (GOS-E score improved by 1 point or more) three months after stimulation ended.
In the first and third months after the stimulus ends

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital of Zhejiang University

Investigators

  • Principal Investigator: Benyan Luo, Prof, Dr, The First Affiliated Hospital, Zhejiang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 5, 2022

Primary Completion (Estimated)

May 10, 2024

Study Completion (Estimated)

October 31, 2024

Study Registration Dates

First Submitted

January 8, 2024

First Submitted That Met QC Criteria

January 8, 2024

First Posted (Estimated)

January 18, 2024

Study Record Updates

Last Update Posted (Estimated)

January 18, 2024

Last Update Submitted That Met QC Criteria

January 8, 2024

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • tACS in pDoC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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