tDCS and rTMS in Patients With Early Disorders of Consciousness

NCT05820178 | Not Yet Recruiting DMC

• 1 other identifier: DOC1
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

A randomized controlled study was conducted to explore the efficacy of early transcranial direct current stimulation (tDCS) and repetitive transcranial magnetic stimulation (rTMS) to promote wakefulness in patients with disorder of consciousness (DOC). In order to improve the prognosis of DOC patients with nontraumatic brain injury, we compared the effects of tDCS and rTMS on clinical behavior and neurophysiological performance, and selected a wake-up technique that could improve the prognosis of DOC patients with nontraumatic brain injury as early as possible, so as to reduce the pain of patients and their loved ones, and to reduce the economic burden of society and families.

Conditions

Disorder of Consciousness; Stroke; Ischemic-hypoxic Encephalopathy

Keywords

Transcranial Direct Current Stimulation; Transcranial Magnetic Stimulation

Outcome Measures

Primary Outcomes (1)

• CRS-R

  The unabbreviated scale title is the coma recovery scale-revised.The CRS-R tests six components: auditory, language, visual, communication, motor and arousal levels, with a total score of 0-23. The lower the score, the more severe the brain damage and the deeper the DOC level.

  day 15 of enrollment

Secondary Outcomes (10)

• GCS

  day 15 of enrollment

• FOUR

  day 15 of enrollment

• MMN

  day 15 of enrollment

• MEP

  day 15 of enrollment

• ABCD model of neural oscillation

  day 15 of enrollment

Study Arms (3)

tDCS treatment group

EXPERIMENTAL

On the basis of conventional treatment, tDCS was given on day 2 after enrollment for a total of 14 days, once a day.

Device: tDCS

rTMS treatment group

EXPERIMENTAL

On the basis of conventional treatment, rTMS was given on day 2 after enrollment for a total of 14 days, once a day.

Device: rTMS

conventional treatment group

NO INTERVENTION

Not receiving any neuromodulation treatment.

Interventions

tDCS DEVICE

On the basis of conventional treatment, tDCS was given on day 2 after enrollment for a total of 14 days, once a day.

tDCS treatment group

rTMS DEVICE

On the basis of conventional treatment, rTMS was given on day 2 after enrollment for a total of 14 days, once a day.

rTMS treatment group

Eligibility Criteria

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

You may qualify if:

• age 18-80 years
• diagnosis of stroke or ischemic-hypoxic encephalopathy confirmed by neuroimaging (head MRI)
• DOC, Glasgow coma score (GCS) \<12 4.2-4 weeks of DOC
• informed consent obtained from the patient's legal representative.

You may not qualify if:

• foreign bodies such as metal or electronic devices in the skull (inside or on the surface of the tissue at the treatment stimulation site)
• pacemaker or cochlear implants
• history of epilepsy and family history of epilepsy
• large cranial defects
• significant cerebral edema lesions in both DLPFC
• pregnant women
• with severe physical diseases such as heart, lung, liver and kidney
• brain death
• new intracerebral lesions in patients during the study period affecting the assessment and prognosis, e.g. new stroke

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead

MeSH Terms

Conditions

Consciousness Disorders; Stroke; Hypoxia-Ischemia, Brain

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Ischemia; Hypoxia, Brain; Hypoxia; Signs and Symptoms, Respiratory

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Central Study Contacts

Yan Zhang, MD

CONTACT

0086-13671376710; zhangylq@sina.com

Study Design

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

Study Record Dates

• First Submitted: April 7, 2023
• First Posted: April 19, 2023
• Study Start: May 1, 2023
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: April 26, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: after Dec 2023, always
• Access Criteria: email to authors