NCT05983211招募中不适用
A Biomarker-Directed Neuromodulation Trial Using Quantitative and Repetitive Transcranial Magnetic Stimulation in Amyotrophic Lateral Sclerosis (The QuARTS-ALS Trial)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Safety and Feasibility of cTBS rTMS in patients with ALS
研究概览
简要总结
Stage 1 [Enrolment closed]:
The goal of this open-label pilot clinical trial is to evaluate the safety and feasibility of accelerated, repetitive transcranial magnetic stimulation (rTMS) using continuous theta-burst stimulation (cTBS) in patients with ALS.
Stage 2 [CURRENTLY ENROLLING]:
The goal of this open-label pilot clinical trial is to evaluate the safety, tolerability and target engagement of accelerated, high dose cTBS using TMS in patients with ALS.
详细描述
Stage 1 [Enrolment closed]:
The purpose of this stage is to evaluate the safety, feasibility, and changes in neuronal excitability biomarkers of accelerated repetitive transcranial magnetic stimulation (rTMS) using continuous theta-burst stimulation (cTBS) inhibitory paradigms over M1 in patients with ALS.
Stage 2 [CURRENTLY ENROLLING]:
The purpose of this study is to:
- Assess the safety and feasibility of accelerated cTBS treatment with maintenance cTBS treatments in individuals with ALS over a 24-week period.
- Assess changes in MR spectroscopy measures of glutamate and GABA, ATP and metabolites markers, and neuronal structure markers, changes in serum neurofilament light chain, and changes in corticohyperexcitability biomarkers measured by single and paired pulse quantitative TMS.
- Assess the changes in ALSFRS-R and muscle strength dynamometry.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis with ALS as per the 2020 Gold Coast Criteria;
- •Age ≥ 18 years;
- •Able to provide informed consent to study procedures and treatments;
- •Patients are allowed to start or continue the standard of care treatments for ALS. Presently these include oral riluzole, and oral or intravenous edaravone;
- •Able to lie supine without BiPAP or breathing discomfort for at least 1 hour;
- •No contraindications to TMS as follow;
- •Metal implants in the head or neck (such as aneurysm clips, vessel stents), implanted medication pump, implanted brain stimulators, pacemaker, cochlear implants, or history of epilepsy. Dental fillings are permitted;
- •Current use of medications or medical conditions that, at the discretion of the Principal Investigator, could potentially increase the risk of seizures or interfere with stage outcomes;
- •On medications that affect TMS measures in a PRN regimen (as needed). Continuous use of these medications on a fixed dose of 30 days prior to first Baseline Visit or after a wash-out period of 2 weeks is accepted. These medications include, but are not limited to: benzodiazepines, muscle relaxants, tricyclic antidepressants, selective and non-selective serotonin reuptake inhibitors, hypnotics (including anti-histamine drugs) and anticholinergics drugs;
- •History of seizure, convulsion, or epilepsy;
排除标准
- •Known diagnosis of dementia;
- •Definitely or possibly pregnant (if applicable);
- •History of allergy to Ag-AgCl electrode gel (standard neurophysiology electrodes);
- •Unable to tolerate TMS procedures;
- •Lack of MRI brain performed prior to the stage, inability to perform an MRI at baseline due to orthopnea, or:
- •Large body habitus and not fitting comfortably into the scanner;
- •Difficulty laying still for up to 1 hour in the MRI unit or significant claustrophobia;
- •Metallic implants;
- •Any contraindications for receiving rTMS treatment as follow:
- •have received rTMS for any previous indication due to the potential compromise of subject blinding;
- •have increased intracranial pressure, a space occupying brain lesion, any history of seizure except those therapeutically induced by ECT or a febrile seizure of infancy, significant head trauma with clear radiological evidence of cerebrovascular injury on imaging;
- •have an intracranial implant or any other metal object within or near the head, excluding the mouth, that cannot be safely removed;
- •have clinically significant laboratory abnormality, in the opinion of the one of the principal investigators or study physicians;
- •are currently taking more than lorazepam 2 mg daily (or equivalent) or any dose of an anticonvulsant due to the potential to limit rTMS efficacy;
- •Any other clinical condition that, in the opinion of the Site Investigator, would place the subject at increased risk or preclude the subject's full compliance with completion of the stage.
结局指标
主要结局
Safety and Feasibility of cTBS rTMS in patients with ALS
时间窗: Up to 30 days before compared to during the initial 5 days of cTBS treatment and up to 24 weeks after
Incidence of AEs and SAEs after accelerated continuous theta burst stimulation inhibitory intervention in individuals with ALS through the incidence of repetitive TMS treatment related adverse events, serious adverse events, and discontinuations due to adverse events/serious adverse events.
次要结局
- Corticospinal Excitability change measured by quantitative TMS(Up to 30 days before compared to 12 and 24 weeks after cTBS treatment)
- Neurofilament light chain (NfL) levels(Up to 30 days before compared to the last treatment day, 12 weeks, and 24 weeks after cTBS treatment)
- Magnetic Resonance Spectroscopy parameters as measured by MRS(Up to 30 days before compared to the end of treatment week, 5 weeks, 12 weeks, and 24 weeks after cTBS treatment)
- ALSFRS-R scores(Up to 30 days before compared to 12 and 24 weeks after cTBS treatment)
研究者
研究点 (2)
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