Bilateral Anodal Cerebellar tDCS for Multidomain Dysfunctions in Patients With Multiple Sclerosis: A Randomized Controlled Trial Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Scale for the Assessment and Rating of Ataxia (SARA)
研究概览
简要总结
The goal of this clinical trial is to learn if brain stimulation can improve movement and daily function in people with multiple sclerosis (MS). The study will also look at how this treatment affects fatigue, sleep, memory and attention, and quality of life.
The main questions this study aims to answer are the following:
Does this treatment improve coordination and balance? Does it reduce fatigue and improve sleep and daily life? Does it change brain activity?
Researchers will compare active brain stimulation to sham stimulation (a look-alike treatment that does not deliver real stimulation) to see if the treatment works.
Participants will:
Receive brain stimulation sessions for two weeks Attend assessment sessions before and after treatment Return for a follow-up visit after four weeks Complete tests of movement, fatigue, sleep, and thinking
详细描述
Multiple sclerosis (MS) is a chronic immune-mediated neurological disorder characterized by demyelination and neurodegeneration within the central nervous system. Disruption of cerebro-cerebellar networks is a key feature of MS and contributes to impairments in motor coordination, balance, gait, fatigue, and cognitive performance. Cerebellar involvement is particularly associated with ataxia and postural instability, which significantly affect functional independence and quality of life.
Transcranial direct current stimulation (tDCS) is a non-invasive neuromodulation technique capable of modulating cortical and cerebellar excitability. Previous studies investigating cerebellar tDCS in MS have reported variable findings, which may be related to heterogeneity in stimulation protocols, the predominant use of unilateral stimulation approaches, and the frequent combination of stimulation with task-oriented rehabilitation. These factors limit the ability to isolate the independent effects of neuromodulation.
The cerebellum operates through bilateral cerebro-cerebellar loops, suggesting that bilateral stimulation may provide more comprehensive modulation of these distributed networks compared to unilateral approaches. In addition, the effects of tDCS are influenced by state-dependent factors, including concurrent motor activity. Delivering stimulation as a standalone intervention allows for clearer evaluation of its direct neuromodulatory effects without the confounding influence of concurrent rehabilitation.
This study is designed as a randomized, double-blind, sham-controlled trial to evaluate the effects of bilateral cerebellar tDCS on multidomain dysfunction in individuals with MS. Participants will be randomly assigned to receive either active or sham stimulation. The intervention consists of repeated sessions of bilateral cerebellar stimulation delivered over a two-week period using a standardized protocol.
The study aims to evaluate the effects of this intervention on motor and non-motor domains and to explore associated neurophysiological changes. By isolating the effects of bilateral cerebellar stimulation, this trial seeks to provide a clearer understanding of its therapeutic potential and to inform the development of targeted neuromodulation strategies in MS rehabilitation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
This study will employ a double-blind design with additional blinding of outcome assessors. Participants and care providers administering the stimulation will be blinded to group allocation through the use of identical stimulation procedures in both active and sham conditions. The tDCS device will be pre-programmed to deliver either active or sham stimulation, ensuring allocation concealment. Investigators involved in data analysis and outcome assessors conducting clinical evaluations will remain blinded to group assignment throughout the study to minimize bias.
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
- •Confirmed diagnosis of Multiple Sclerosis according to the revised McDonald criteria
- •Adult Age > 18 years
- •Expanded Disability Status Scale (EDSS) score between 2.0 and 6.0
- •Clinically stable disease status for at least 3 months prior to enrollment
- •On stable disease-modifying therapy (DMT) for at least 3 months
- •Ability to understand study procedures and provide informed consent
- •Ability to ambulate independently or with assistive devices sufficient to complete motor assessments
排除标准
- •Multiple sclerosis relapse within the past 3 months
- •History of epilepsy or seizures
- •Presence of implanted electronic devices (e.g., pacemaker, neurostimulator)
- •Metallic implants in the head or skull incompatible with transcranial magnetic stimulation (TMS)
- •Severe cognitive impairment preventing participation in assessments
- •Pregnancy or planned pregnancy during the study period
- •Other neurological or psychiatric disorders that may confound study outcomes
- •Severe musculoskeletal or orthopedic conditions interfering with motor performance testing
- •Contraindications to non-invasive brain stimulation or TMS
研究组 & 干预措施
Sham Bilateral Cerebellar tDCS
Participants in this arm will receive sham bilateral cerebellar transcranial direct current stimulation (ctDCS). Electrodes will be positioned identically to the active stimulation group (bilateral cerebellar montage). The device will deliver a brief ramp-up and ramp-down of current at the beginning and end of the session to mimic the sensation of active stimulation, but no continuous current will be applied. Each session will last 20 minutes, 5 sessions per week for 2 consecutive weeks (total of 10 sessions). This procedure is designed to maintain participant blinding.
干预措施: Sham Bilateral Cerebellar tDCS (Device)
TDCS GROUP
Participants in this arm will receive bilateral cerebellar transcranial direct current stimulation (ctDCS). Anodal electrodes will be positioned bilaterally over the cerebellar hemispheres (3 cm lateral to the inion), with reference electrodes placed over the buccinator muscles. Stimulation will be delivered at 2 mA for 20 minutes per session, 5 sessions per week for 2 consecutive weeks (total of 10 sessions). The intervention will be administered as a standalone neuromodulation protocol without concurrent task-oriented rehabilitation to isolate neuro-modulatory effects.
干预措施: Bilateral Cerebellar Transcranial Direct Current Stimulation (ctDCS) (Device)
结局指标
主要结局
Scale for the Assessment and Rating of Ataxia (SARA)
时间窗: Baseline (within 7 days prior to the first intervention session), immediately post-intervention (within 7 days after completion of the 10-session intervention), and at 4-week follow-up.
The Scale for the Assessment and Rating of Ataxia (SARA) is an 8-item clinical scale used to assess cerebellar ataxia, including gait, stance, sitting balance, speech, and limb coordination. Total scores range from 0 (no ataxia) to 40 (most severe ataxia), where higher scores indicate worse ataxia.
次要结局
- The balance evaluation systems test (mini-BESTest)(Baseline (within 7 days prior to the first intervention session), immediately post-intervention (within 7 days after the final session), and 4 weeks post-intervention.)
- Timed Up and Go (TUG)(Baseline (within 7 days prior to the first intervention session), immediately post-intervention (within 7 days after the final session), and 4 weeks post-intervention.)
- Six-Minute Walk Test (6MWT)(Baseline (within 7 days prior to the first intervention session), immediately post-intervention (within 7 days after the final session), and 4 weeks post-intervention.)
- Modified Tardieu Scale (MTS)(Baseline (within 7 days prior to the first intervention session), immediately post-intervention (within 7 days after the final session), and 4 weeks post-intervention.)
- Modified Fatigue Impact Scale (MFIS)(Baseline (within 7 days prior to the first intervention session), immediately post-intervention (within 7 days after the final session), and 4 weeks post-intervention.)
- Pittsburgh Sleep Quality Index (PSQI)(Baseline (within 7 days prior to the first intervention session), immediately post-intervention (within 7 days after the final session), and 4 weeks post-intervention.)
- Multiple Sclerosis Quality of Life-54 (MSQOL-54)(Baseline (within 7 days prior to the first intervention session), immediately post-intervention (within 7 days after the final session), and 4 weeks post-intervention.)
- Symbol Digit Modalities Test (SDMT)(Baseline (within 7 days prior to the first intervention session), immediately post-intervention (within 7 days after the final session), and 4 weeks post-intervention.)
- Montreal Cognitive Assessment (MoCA)(Baseline (within 7 days prior to the first intervention session), immediately post-intervention (within 7 days after the final session), and 4 weeks post-intervention.)
- Resting-State EEG(Baseline (within 7 days prior to the first intervention session) and immediately post-intervention (within 7 days after the final session).)
- Motor Evoked Potential (MEP) Amplitude(Baseline (within 7 days prior to the first intervention session) and immediately post-intervention (within 7 days after the final session).)
- Resting Motor Threshold (RMT)(Baseline (within 7 days prior to the first intervention session) and immediately post-intervention (within 7 days after the final session).)
研究者
Hikmat Hadoush
Associate professor
University of Sharjah