Clinical trial NCT05820178: tDCS and rTMS in Patients With Early Disorders of Consciousness
Official title: A Prospective Randomized Controlled Study of the Efficacy of tDCS and rTMS in Promoting Wakefulness in Patients With Early Disorders of Consciousness
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Disorder of Consciousness
Stroke
Ischemic-hypoxic Encephalopathy
Keywords: Transcranial Direct Current Stimulation
Transcranial Magnetic Stimulation
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
First posted: 2023-04-19
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: CRS-R
timeFrame: day 15 of enrollment
Secondary outcomes:
measure: GCS
timeFrame: day 15 of enrollment
measure: FOUR
timeFrame: day 15 of enrollment
measure: MMN
timeFrame: day 15 of enrollment
measure: MEP
timeFrame: day 15 of enrollment
measure: ABCD model of neural oscillation
timeFrame: day 15 of enrollment
measure: brain network transfer entropy
timeFrame: day 15 of enrollment
measure: brain network phase synchronization
timeFrame: day 15 of enrollment
measure: Prognostic scores (mRS)
timeFrame: 3 months, 6 months, 12 months after DOC
measure: Prognostic scores (GOS)
timeFrame: 3 months, 6 months, 12 months after DOC
measure: Prognostic scores (CRS-R)
timeFrame: 3 months, 6 months, 12 months after DOC
Other outcomes:
Locations:
Study officials:
References: