Clinical trial NCT05187000: Effects of Individualized rTMS in DOC Patients
Official title: Effect of Individualized Repetitive Transcranial Magnetic Stimulation (rTMS) in Patients With Disorder of Consciousness
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Disorder of Consciousness
Transcranial Magnetic Stimulation
Keywords: Disorder of Consciousness
repetitive transcranial magnetic stimulation
randomized control trial
Lead sponsor: Zhujiang Hospital
Sponsor class: OTHER
First posted: 2022-01-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. acquired brain injuries less than 1 year and more than 28 days in DOC;
2. clinical diagnosis of DOC Disease;
3. no medical history of neuropsychiatric diseases;
4. no contraindications for rTMS or EEG, no sedatives in use or other drugs that might interfere with brain stimulation, such as Na+ or Ca2+ channel blockers or NMDA receptor antagonists;
5. stable state of disease and vital signs;
6. the families of the patients volunteered the patient to participate in the study and provided signed informed consent;
7. the integrity of the individualized stimulation target cortex are verified by MRI.

Exclusion Criteria:

1. patients in other non-invasive or invasive neuroregulation trials;
2. motor evoked potential (MEP) in M1 region cannot be induced by TMS pulse;
3. uncontrolled epilepsy, seizure within 4 weeks before enrollment;
4. metallic implant in the skull, pacemaker, craniotomy under the stimulated site, implanted brain device.

Primary outcomes:
measure: Change from Baseline JFK Coma Recovery Scale-Revised(CRS-R) for Crossover Study 1
timeFrame: immediately after 10 days individualized rTMS session
measure: Change from Baseline JFK Coma Recovery Scale-Revised(CRS-R) for Crossover Study 2
timeFrame: immediately after Washout period
measure: Change from Baseline JFK Coma Recovery Scale-Revised(CRS-R) for Crossover Study 3
timeFrame: immediately after 10 days sham rTMS session
Secondary outcomes:
measure: Change from Baseline Resting-State EEG for Crossover Study 1
timeFrame: immediately after 10 days individualized rTMS session
measure: Change from Baseline Resting-State EEG for Crossover Study 2
timeFrame: immediately after Washout period
measure: Change from Baseline Resting-State EEG for Crossover Study 3
timeFrame: immediately after 10 days sham rTMS session
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhujiang Hospital of Southern Medical University
state: Guangdong
Study officials:
References: