tDCS and rTMS in Patients With Early Disorders of Consciousness

NCT ID: NCT05820178

Last Updated: 2023-04-26

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-01
• Study Completion Date: 2026-04-01

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.

Detailed Description

To study the efficacy of wakefulness promotion in patients with acute DOC due to severe non-traumatic brain injury (including stroke and ischemic-hypoxic encephalopathy), patients with early DOC were randomly divided into conventional treatment group, tDCS treatment group and rTMS treatment group for 14 consecutive days. Clinical scoring, evoked potential assessment, resting-state high-density electroencephalogram(EEG) and TMS-EEG assessment with functional analysis of brain network connectivity were applied for multidimensional assessment of brain function before and after wake-up promotion treatment (day 1 and day 15 of enrollment) to explore non-invasive brain stimulation(NIBS) techniques that can be performed at the bedside - tDCS, rTMS intervention The prognostic follow-up was performed at 3 months, 6 months and 12 months after DOC to compare the awakening rate after tDCS and rTMS prolongation treatment, and to preferably select an effective prolongation technique for early DOC. The safety of tDCS and rTMS was also clarified by comparing the differences in adverse effects and complications between tDCS treatment group and rTMS treatment group and conventional treatment group.

Conditions

Disorder of Consciousness; Stroke; Ischemic-hypoxic Encephalopathy

Study Design

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

Study Groups

tDCS treatment group

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

Group Type: EXPERIMENTAL

tDCS

Intervention Type: DEVICE

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

rTMS treatment group

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

Group Type: EXPERIMENTAL

rTMS

Intervention Type: DEVICE

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

conventional treatment group

Not receiving any neuromodulation treatment.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

tDCS

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

Intervention Type: DEVICE

rTMS

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. age 18-80 years

2. diagnosis of stroke or ischemic-hypoxic encephalopathy confirmed by neuroimaging (head MRI)

3. DOC, Glasgow coma score (GCS) <12 4.2-4 weeks of DOC

5.informed consent obtained from the patient's legal representative.

Exclusion Criteria

1. foreign bodies such as metal or electronic devices in the skull (inside or on the surface of the tissue at the treatment stimulation site)

2. pacemaker or cochlear implants

3. history of epilepsy and family history of epilepsy

4. large cranial defects

5. significant cerebral edema lesions in both DLPFC

6. pregnant women

7. with severe physical diseases such as heart, lung, liver and kidney

8. brain death

9. new intracerebral lesions in patients during the study period affecting the assessment and prognosis, e.g. new stroke

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xuanwu Hospital, Beijing

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Yan Zhang, MD

Role: CONTACT

zhangylq@sina.com

0086-13671376710

Other Identifiers

DOC1

Identifier Type: -

Identifier Source: org_study_id