Transcranial Direct Current Stimulation in Patients With Disorders of Consciousness

NCT03809936 | Completed

• 1 other identifier: tDCS
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

To date, several studies have focused on the use of transcranial direct current stimulation(tDCS) in patients with impaired consciousness.However,its therapeutic effects have been variously documented.So,in this study ,investigators explore the effects of tDCS.

Conditions

Disorder of Consciousness

Keywords

tDCS; EEG

Outcome Measures

Primary Outcomes (1)

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

  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), 1 week 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), 1 week later (T2).

Study Arms (2)

real tDCS

ACTIVE COMPARATOR

real tDCS:anodal transcranial direct current stimulation were delivered over the left DLPF cortex for 20 minutes in patients.

Device: real tDCS

sham tDCS

SHAM COMPARATOR

sham tDCS:sham transcranial direct current stimulation were delivered over the left DLPF cortex for 20 minutes in patients.

Device: sham tDCS

Interventions

real tDCS DEVICE

Direct current was applied by a battery-driven constant current stimulator using saline-soaked surface sponge electrodes (7 3 5 cm) with the anode positioned over the left dorsolateral prefrontal cortex (F3 according to the 10-20 international system for EEG placement) and the cathode placed over the right supraorbital region. During real tDCS, the current was increased to 2 mA from the onset of stimulation and applied for 20 minutes.

real tDCS

sham tDCS DEVICE

For the sham condition(sham tDCS), the same electrode placement was used as in the stimulation condition, but the current was applied for only 5 seconds, and was then ramped down.

sham tDCS

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:

• Clinical diagnosis of DOC
• Ages 14 to 65 years old
• No centrally acting drugs
• No neuromuscular function blockers and no sedation within the prior 24 hours;

You may not qualify if:

• History with nervous or spirit disorders, or some other serious diseases
• A contraindication for tDCS

Sponsors & Collaborators

• First Affiliated Hospital of Zhejiang University: lead

Study Sites (1)

Hangzhou Hospital of Zhejiang CAPR

Hangzhou, Zhejiang, China

Location

Related Publications (2)

• Yu J, Wu Y, Wu B, Xu C, Cai J, Wen X, Meng F, Zhang L, He F, Hong L, Gao J, Li J, Yu J, Luo B. Sleep patterns correlates with the efficacy of tDCS on post-stroke patients with prolonged disorders of consciousness. J Transl Med. 2022 Dec 15;20(1):601. doi: 10.1186/s12967-022-03710-2.

  PMID: 36522680 DERIVED

• Wu M, Yu Y, Luo L, Wu Y, Gao J, Ye X, Luo B. Efficiency of Repetitive Transcranial Direct Current Stimulation of the Dorsolateral Prefrontal Cortex in Disorders of Consciousness: A Randomized Sham-Controlled Study. Neural Plast. 2019 Jun 11;2019:7089543. doi: 10.1155/2019/7089543. eCollection 2019.

  PMID: 31308848 DERIVED

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

  The First Affiliated Hospital, Zhejiang University

  PRINCIPAL INVESTIGATOR

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, 20 patients were randomly assigned to either a real or sham stimulation group. Each intervention week included 10 daily sessions of 20-minute therapy with either anodal transcranial direct current stimulation (2 mA, 20 minutes; experimental group) or sham transcranial direct current stimulation (control group) over the left dorsolateral prefrontal cortex (DLPFC).

Study Record Dates

• First Submitted: July 26, 2018
• First Posted: January 18, 2019
• Study Start: April 2, 2019
• Primary Completion: January 2, 2020
• Study Completion: December 31, 2020
• Last Updated: May 27, 2022

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)