Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
All Genders
NCT06527573

Effects of rTMS With Different Stimulation Spots in Patients With Disorders of Consciousness

Led by Zhujiang Hospital · Updated on 2024-07-30

84

Participants Needed

1

Research Sites

100 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Disorders of consciousness are a state in which consciousness is affected by brain damage, resulting in dysfunctions in alertness, awareness, and behavior. Patients with disorders of consciousness can be categorized into coma, unresponsive arousal syndrome(UWS), and minimally conscious states(MCS). Common causes include craniocerebral trauma and non-craniocerebral trauma causes such as stroke and ischemic-hypoxic encephalopathy. The number of patients with disorders of consciousness is rapidly increasing worldwide and is not only affecting the lives of individuals and their families, but is becoming a serious public health threat.Transcranial magnetic stimulation uses an electromagnetic pulse to induce focalised neural depolarisation and firing. Repeated transcranial magnetic stimulation, compared with single pulse transcranial magnetic stimulation, can influence brain plasticity and cortical organisation through alterations of neuronal excitability and is now being used to improve consciousness and functional recovery in patients with disorders of consciousness. However, the optimization of TMS stimulation parameters has become one of the key factors affecting the therapeutic efficacy, especially the choice of treatment location. Method:This study is a randomized double-blind controlled trial.And eighty-four patients are expected to be recruited and they will be randomly assigned in a 1:1:1 ratio to two test groups and one control group of 28 patients each.. Each patient receives a one-week period of repetitive transcranial magnetic stimulation at 10 Hz twice daily for a total of 14 treatments. Primary and secondary evaluation indices will be performed at each baseline and after rTMS treatment. 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 and TMS-EEG will be also recorded to investigate the neurophysiological correlates by rTMS. Discussion:This study will contribute to the selection of therapeutic target locations for rTMS in patients with disorders of consciousness and has the potential to explore mechanisms of consciousness and to validate the role of rTMS parameter optimization in patients with disorders of consciousness using randomized controlled trials

CONDITIONS

Official Title

Effects of rTMS With Different Stimulation Spots in Patients With Disorders of Consciousness

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Acquired brain injury between 28 days and 1 year prior with a disorder of consciousness
  • Clinical diagnosis of disorder of consciousness
  • No history of neuropsychiatric diseases
  • No contraindications for rTMS or EEG; not using sedatives or drugs interfering with brain stimulation
  • Stable disease condition and vital signs
  • Individualized stimulation target cortex verified by MRI
Not Eligible

You will not qualify if you...

  • Participation in other neuroregulation trials
  • Motor evoked potential cannot be induced by TMS in the motor region
  • Uncontrolled epilepsy or seizure within 4 weeks before enrollment
  • Presence of metallic implants in the skull, pacemaker, craniotomy under stimulated site, or implanted brain devices

AI-Screening

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Trial Site Locations

Total: 1 location

1

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangzhou, China, 510280

Actively Recruiting

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Research Team

Z

ziqin Liao, BSc

CONTACT

Q

Qiuyou Xie, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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Effects of rTMS With Different Stimulation Spots in Patients With Disorders of Consciousness | DecenTrialz