Actively Recruiting
Effects of Individualized rTMS in DOC Patients
Led by Qiuyou Xie · Updated on 2024-07-26
30
Participants Needed
1
Research Sites
195 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Background: Disorder of consciousness(DOC) is a series of arousal and cognitive disorders secondary to the most severe brain injury. Once a patient is diagnosed with a DOC, a poor prognosis is assumed and the rehabilitation for whom is greatly limited. Therefore, the treatment of DOC poses extraordinary challenges. Various treatments protocols have been reported of successful in promoting rehabilitation of DOC patients. Repetitive transcranial magnetic stimulation(rTMS), as a non-invasive brain stimulation technique, has shown potentials for consciousness rehabilitation of DOC patients as it is effective in regulating the central nervous system. Methods and design: This protocol is a double-blind randomized sham-controlled crossover trial. Totally 30 participants will be randomly assigned to either group 1 or group 2 in a 1:1 ratio, with 15 patients in each group. Each patient will received 20 sessions, in which 10 sessions will be active and 10 will be sham, separated by 10-days washout period. The active-rTMS will include 10 Hz rTMS over the individual-targeted area on each participants. Primary and secondary evaluating indicators will be performed at each baseline and after rTMS treatment. Primary outcome will be determined as behavioral response to treatment as measured using the Coma Recovery Scale - Revised (CRS-R). Resting-state high-density EEG will be also recorded to investigate the neurophysiological correlates by rTMS. Discussion:This study will contribute to define the role of rTMS for the treatment of DOC patients and characterise the neural correlates of its action. The investigators proposed a method of individualized target selection for DOC patients based on the existing gold standard CRS-R score and MRI, and used a cross randomized controlled trial to verify the role of rTMS in DOC treatment.
CONDITIONS
Official Title
Effects of Individualized rTMS in DOC Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Acquired brain injuries less than 1 year and more than 28 days in disorder of consciousness
- Clinical diagnosis of disorder of consciousness
- No medical history of neuropsychiatric diseases
- No contraindications for rTMS or EEG, and not using sedatives or drugs interfering with brain stimulation such as sodium or calcium channel blockers or NMDA receptor antagonists
- Stable disease condition and vital signs
- Signed informed consent provided by patient's family
- Individualized stimulation target cortex verified by MRI
You will not qualify if you...
- Participation in other neuroregulation trials (invasive or non-invasive)
- Motor evoked potential in M1 region cannot be induced by TMS pulse
- Uncontrolled epilepsy or seizure within 4 weeks before enrollment
- Metallic implant in the skull, pacemaker, craniotomy under the stimulated site, or implanted brain device
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, China, 510280
Actively Recruiting
Research Team
C
Chengwei Xu, BSc
CONTACT
Q
Qiuyou Xie, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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