Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
All Genders
ID05187000

Effect of Individualized Repetitive Transcranial Magnetic Stimulation (rTMS) in Patients With Disorder of Consciousness

Led by Qiuyou Xie · Updated on 2024-07-26

30

Participants Needed

1

Research Sites

12 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the effects of individualized repetitive transcranial magnetic stimulation (rTMS) for patients with Disorder of Consciousness (DOC), a condition involving severe brain injury that results in impaired arousal and cognition. This randomized, double-blind, sham-controlled crossover trial aims to understand how rTMS may help improve consciousness rehabilitation by targeting specific brain areas based on each patient's MRI and clinical scores. The study will also explore the neural changes associated with rTMS using high-density EEG recordings. Participants will be randomly assigned to receive both active and sham rTMS treatments in a crossover design, with 20 sessions total: 10 sessions of active rTMS and 10 sessions of sham stimulation separated by a 10-day washout period. Active rTMS involves 10 Hz stimulation over personalized brain targets for 20 minutes daily, while sham stimulation uses a coil that mimics the experience without delivering magnetic pulses. This approach allows comparison of the effects of real versus sham stimulation on patients' recovery. During the study, participants will undergo baseline and post-treatment assessments using the Coma Recovery Scale-Revised (CRS-R) to measure behavioral responses. Resting-state EEG will also be recorded to evaluate brain activity changes. The study involves careful monitoring of participants' clinical status and vital signs, with family consent required. The total duration includes active and sham treatment periods with washout, providing detailed insight into the role of rTMS in DOC rehabilitation.

CONDITIONS

Brief Title

Effects of Individualized rTMS in DOC Patients

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 Disorder of Consciousness
  • Clinical diagnosis of Disorder of Consciousness
  • No history of neuropsychiatric diseases
  • No contraindications for rTMS or EEG, and not using sedatives or drugs that interfere with brain stimulation such as Na+, Ca2+ channel blockers, or NMDA receptor antagonists
  • Stable disease state and vital signs
  • Family has given informed consent for participation
  • Integrity of individualized stimulation target cortex verified by MRI
Not Eligible

You will not qualify if you...

  • Participation in other neuroregulation trials
  • Unable to induce motor evoked potential in M1 region by TMS pulse
  • Uncontrolled epilepsy or seizure within 4 weeks before enrollment
  • Metallic implants in skull, pacemaker, craniotomy under stimulation site, or implanted brain device

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 10 consecutive days per treatment phase

Participants receive individualized repetitive transcranial magnetic stimulation (rTMS) or sham stimulation in a crossover design.

Daily visits for 10 sessions per treatment phase

Washout Period

Duration - Duration not specified

Participants undergo a washout period between crossover treatment phases to allow effects to dissipate.

No visits scheduled during washout

Trial Site Locations

Total: 1 location

1

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, China, 510280

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Research Team

C

Chengwei Xu, BSc

Q

Qiuyou Xie, PhD

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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Published Research Related To This Trial

Perturbational complexity index in assessing responsiveness to rTMS treatment in patients with disorders of consciousness: a cross-over randomized controlled trial study.

Chengwei Xu, Zhanxing Yuan, Zerong Chen...

https://pubmed.ncbi.nlm.nih.gov/39300529

Effects of 10 Hz individualized repetitive transcranial magnetic stimulation on patients with disorders of consciousness: a study protocol for an exploratory double-blind crossover randomized sham-controlled trial.

Chengwei Xu, Zhaohua Zhu, Wanchun Wu...

https://pubmed.ncbi.nlm.nih.gov/37005647

Repetitive transcranial magnetic stimulation over the posterior parietal cortex improves functional recovery in nonresponsive patients: A crossover, randomized, double-blind, sham-controlled study.

Chengwei Xu, Wanchun Wu, Xiaochun Zheng...

https://pubmed.ncbi.nlm.nih.gov/36873436