NCT05820178

tDCS and rTMS in Patients With Early Disorders of Consciousness

A Prospective Randomized Controlled Study of the Efficacy of tDCS and rTMS in Promoting Wakefulness in Patients With Early Disorders of Consciousness

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Xuanwu Hospital, Beijing · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Interventions

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

Timeline

• Start date: 2023-05-01
• Primary completion: 2026-04-01
• Completion: 2026-04-01
• First posted: 2023-04-19
• Last updated: 2023-04-26