Transcranial Alternating Current Stimulation in Patients With Disorders of Consciousness

NCT ID: NCT06211439

Last Updated: 2024-01-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-05
• Study Completion Date: 2024-10-31

Brief Summary

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 .

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.

Conditions

Consciousness Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

real transcranial alternating current stimulation

Intervention Type: DEVICE

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 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.

Group Type: SHAM_COMPARATOR

sham transcranial alternating current stimulation

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Affiliated Hospital of Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Benyan Luo, Prof, Dr

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital, Zhejiang University

Locations

The First Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jun Hu

Role: CONTACT

18788432767@163.com

0571-87235859

Benyan Luo, Dr

Role: CONTACT

luobenyan@zju.edu.cn

0571-87235859

Facility Contacts

Benyan Luo, Prof,PhD

Role: primary

luobenyan@zju.edu.cn

0571-87235859

Other Identifiers

tACS in pDoC

Identifier Type: -

Identifier Source: org_study_id