Transcranial Alternating Current Stimulation in Patients With Disorders of Consciousness

NCT06211439 | Unknown DMC

• 1 other identifier: tACS in pDoC
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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. 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. 2.Further investigate the awakening mechanism of consciousness disorders through HD-tACS stimulation using multimodal assessment;
3. 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 .

Conditions

Consciousness Disorders

Keywords

disorders of consciousness; Transcranial alternating current stimulation; tACS; EEG

Outcome Measures

Primary Outcomes (1)

• the JFK Coma Recovery Scale-Revised (CRS-R) scale

  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 Outcomes (1)

• EEG data ( electrophysiological parameters)

  at baseline (T0), immediately after the end of the treatment (T1), 5 days later (T2)

Other Outcomes (1)

• Glasgow Outcome Scale-Extended (GOS-E)

  In the first and third months after the stimulus ends

Study Arms (2)

Transcranial electrical stimulation HD-tES

ACTIVE COMPARATOR

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

sham Transcranial electrical stimulation HD-tES

SHAM COMPARATOR

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

Interventions

real transcranial alternating current stimulation 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.

Transcranial electrical stimulation HD-tES

sham transcranial alternating current stimulation 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.

sham Transcranial electrical stimulation HD-tES

Eligibility Criteria

• Age: 14 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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;

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• First Affiliated Hospital of Zhejiang University: lead

Study Sites (1)

The First Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, 310000, China

RECRUITING

MeSH Terms

Conditions

Consciousness Disorders

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Benyan Luo, Prof, Dr

  The First Affiliated Hospital, Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jun Hu

CONTACT

0571-87235859; 18788432767@163.com

Benyan Luo, Dr

CONTACT

0571-87235859; luobenyan@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Using a sham-controlled randomized double-blind design, 64 patients were randomly assigned to either a real or sham stimulation group. In the real stimulation group, stimulation of different frequencies (40Hz gamma, 4Hz theta) is applied to the left dorsolateral prefrontal cortex with a current intensity of 2mA for 20 minutes each day, continuously for 5 days. In the sham stimulation group, the tACS stimulation mode and frequency are the same as in the real stimulation group, but current is only applied during the first and last 30 seconds of the entire 20-minute stimulation period.

Study Record Dates

• First Submitted: January 8, 2024
• First Posted: January 18, 2024
• Study Start: December 5, 2022
• Primary Completion: May 10, 2024
• Study Completion: October 31, 2024
• Last Updated: January 18, 2024

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)