[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100635645":3},{"organization":4,"outcomesModule":7,"designInfo":53,"detailedDescription":65,"studyPopulation":52,"armGroups":66,"interventions":79,"overallOfficials":90,"centralContacts":94,"locations":103,"responsibleParty":114,"collaborators":52,"id":117,"slug":52,"hasResults":118,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":122,"eligibilityCriteria":123,"healthyVolunteers":118,"sex":124,"minAge":125,"maxAge":52,"enrollmentInfo":126,"targetDuration":52,"studyType":129,"phases":130,"briefSummary":132,"conditions":133,"keywords":135,"overallStatus":152,"whyStopped":52,"lastUpdateSubmitDate":153,"lastUpdatePostDateStruct":154,"startDateStruct":157,"completionDateStruct":159,"leadSponsor":161,"locationsCount":162},{"fullName":5,"class":6},"University of Sharjah","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":52},[9],{"measure":10,"description":11,"timeFrame":12},"Scale for the Assessment and Rating of Ataxia (SARA)","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.\n\nTotal scores range from 0 (no ataxia) to 40 (most severe ataxia), where higher scores indicate worse ataxia.","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.",[14,18,21,24,27,30,33,36,39,42,46,49],{"measure":15,"description":16,"timeFrame":17},"The balance evaluation systems test (mini-BESTest)","The Mini-Balance Evaluation Systems Test (Mini-BESTest) is a 14-item clinical scale assessing dynamic balance, including anticipatory control, reactive responses, sensory orientation, and gait stability.\n\nTotal scores range from 0 (severe balance impairment) to 28 (normal balance), where higher scores indicate better balance performance.","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.",{"measure":19,"description":20,"timeFrame":17},"Timed Up and Go (TUG)","The Timed Up and Go (TUG) test measures functional mobility as the time required to stand up from a chair, walk 3 meters, turn, return, and sit down.\n\nMeasured in seconds (s), with no fixed minimum or maximum values, where lower times indicate better functional mobility.",{"measure":22,"description":23,"timeFrame":17},"Six-Minute Walk Test (6MWT)","The Six-Minute Walk Test (6MWT) assesses walking endurance by measuring the total distance walked over 6 minutes.\n\nMeasured in meters (m), with no fixed maximum value, where higher distances indicate better functional performance.",{"measure":25,"description":26,"timeFrame":17},"Modified Tardieu Scale (MTS)","The Modified Tardieu Scale (MTS) assesses spasticity by measuring muscle response to passive stretch at different velocities, including angle of muscle reaction and quality of response.\n\nScoring depends on joint and muscle group assessed and does not have a single fixed total score range; however, higher scores indicate greater spasticity (worse outcome).",{"measure":28,"description":29,"timeFrame":17},"Modified Fatigue Impact Scale (MFIS)","The Modified Fatigue Impact Scale (MFIS) is a 21-item questionnaire assessing the impact of fatigue on physical, cognitive, and psychosocial function.\n\nTotal scores range from 0 (no fatigue impact) to 84 (maximum fatigue impact), where higher scores indicate worse fatigue.",{"measure":31,"description":32,"timeFrame":17},"Pittsburgh Sleep Quality Index (PSQI)","The Pittsburgh Sleep Quality Index (PSQI) assesses sleep quality and disturbances over the past month.\n\nTotal scores range from 0 (good sleep quality) to 21 (poor sleep quality), where higher scores indicate worse sleep quality.",{"measure":34,"description":35,"timeFrame":17},"Multiple Sclerosis Quality of Life-54 (MSQOL-54)","The Multiple Sclerosis Quality of Life-54 (MSQOL-54) is a multidimensional questionnaire assessing health-related quality of life, including physical and mental health domains.\n\nComposite scores range from 0 (poor quality of life) to 100 (best quality of life), where higher scores indicate better quality of life.",{"measure":37,"description":38,"timeFrame":17},"Symbol Digit Modalities Test (SDMT)","The Symbol Digit Modalities Test (SDMT) assesses cognitive processing speed by measuring the number of correct symbol-digit pairings completed within a fixed time period.\n\nScores are reported as the number of correct responses, with no fixed maximum value, where higher scores indicate better cognitive performance.",{"measure":40,"description":41,"timeFrame":17},"Montreal Cognitive Assessment (MoCA)","The Montreal Cognitive Assessment (MoCA) is a screening tool for global cognitive function, including attention, memory, executive function, and visuospatial ability.\n\nTotal scores range from 0 (severe impairment) to 30 (normal cognition), where higher scores indicate better cognitive function.",{"measure":43,"description":44,"timeFrame":45},"Resting-State EEG","Resting-state electroencephalography (EEG) will be used to assess cortical activity and neural oscillatory dynamics. Quantitative EEG analysis will be performed using power spectral density (PSD) to evaluate frequency-specific activity across standard frequency bands, including delta (1-4 Hz), theta (4-8 Hz), alpha (8-13 Hz), and beta (13-30 Hz).Measured in microvolts squared (µV²), with no fixed minimum or maximum values, where changes\n\nAbsolute and relative power within each frequency band will be calculated. In addition, regional analysis (frontal, central, parietal regions) may be conducted to examine spatial distribution of cortical activity.\n\nChanges in EEG power spectral density are interpreted as indicators of altered cortical excitability and functional brain activity. For example, increases in alpha power may reflect improved neural efficiency and network organization, whereas changes in theta or beta activity may indicate modulation of cognitive and sensorimotor processes.","Baseline (within 7 days prior to the first intervention session) and immediately post-intervention (within 7 days after the final session).",{"measure":47,"description":48,"timeFrame":45},"Motor Evoked Potential (MEP) Amplitude","Motor evoked potential (MEP) amplitude, measured using transcranial magnetic stimulation (TMS) over the primary motor cortex (M1), reflects corticospinal excitability.\n\nValues are expressed in millivolts (mV), with no fixed minimum or maximum values, where higher values indicate greater corticospinal excitability.",{"measure":50,"description":51,"timeFrame":45},"Resting Motor Threshold (RMT)","Resting motor threshold (RMT), measured using transcranial magnetic stimulation (TMS) over the primary motor cortex (M1), represents the minimum stimulation intensity required to elicit a motor response at rest.\n\nValues are expressed as a percentage of maximum stimulator output (%), with no fixed minimum or maximum values, where lower values indicate greater corticospinal excitability.",null,{"allocation":54,"interventionModel":55,"interventionModelDescription":56,"primaryPurpose":57,"observationalModel":52,"timePerspective":52,"maskingInfo":58},"RANDOMIZED","PARALLEL","This study is a randomized, double-blind, sham-controlled, parallel-group trial. Participants will be randomly allocated to either an active bilateral cerebellar transcranial direct current stimulation (ctDCS) group or a sham stimulation group in a 1:1 ratio. The parallel design allows for direct comparison of outcomes between groups to evaluate the efficacy of bilateral cerebellar neuromodulation in individuals with multiple sclerosis.","TREATMENT",{"masking":59,"maskingDescription":60,"whoMasked":61},"TRIPLE","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.",[62,63,64],"PARTICIPANT","CARE_PROVIDER","OUTCOMES_ASSESSOR","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.\n\nTranscranial 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.\n\nThe 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.\n\nThis 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.\n\nThe 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.",[67,73],{"label":68,"type":69,"description":70,"interventionNames":71},"Sham Bilateral Cerebellar tDCS","SHAM_COMPARATOR","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.",[72],"Device: Sham Bilateral Cerebellar tDCS",{"label":74,"type":75,"description":76,"interventionNames":77},"TDCS GROUP","EXPERIMENTAL","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.",[78],"Device: Bilateral Cerebellar Transcranial Direct Current Stimulation (ctDCS)",[80,87],{"type":81,"name":82,"description":83,"armGroupLabels":84,"otherNames":85},"DEVICE","Bilateral Cerebellar Transcranial Direct Current Stimulation (ctDCS)","Bilateral cerebellar transcranial direct current stimulation (ctDCS) will be delivered using a constant-current stimulator. Anodal electrodes (5 × 5 cm; 25 cm²) will be positioned bilaterally over the cerebellar hemispheres (approximately 3 cm lateral to the inion), with reference electrodes placed over the buccinator muscles. Stimulation will be applied at 2 mA for 20 minutes per session. Participants will receive five sessions per week for two consecutive weeks (total of 10 sessions).",[74],[86],"Cerebellar tDCS",{"type":81,"name":68,"description":88,"armGroupLabels":89,"otherNames":52},"Sham bilateral cerebellar transcranial direct current stimulation (ctDCS) will be delivered using the same electrode placement as the active condition. The current will be ramped up and down at the beginning and end of the session to mimic the sensation of stimulation without delivering continuous current. Each session will last 20 minutes, with five sessions per week for two consecutive weeks (total of 10 sessions).",[68],[91],{"name":92,"affiliation":5,"role":93},"Hikmat hadoush","PRINCIPAL_INVESTIGATOR",[95,100],{"name":96,"role":97,"phone":98,"phoneExt":52,"email":99},"Hikmat Hadoush PhD, PhD","CONTACT","+971561445325","hhadoush@sharjah.ac.ae",{"name":101,"role":97,"phone":102,"phoneExt":52,"email":99},"Hikmat Hadoush Associate Professor, Associate Professor","00971561445325",[104],{"facility":5,"status":52,"city":105,"state":52,"zip":52,"country":106,"countryCode":107,"cosmosGeoPoint":108,"geoPoint":113,"contacts":52},"Sharjah city","United Arab Emirates","AE",{"type":109,"coordinates":110},"Point",[111,112],55.41221,25.3342,{"lat":112,"lon":111},{"type":93,"investigatorFullName":115,"investigatorTitle":116,"investigatorAffiliation":5,"oldNameTitle":52,"oldOrganization":52},"Hikmat Hadoush","Associate professor","100635645",false,"NCT07555379","Bilateral Anodal Cerebellar tDCS for Multidomain Dysfunctions in Patients With Multiple Sclerosis","Bilateral Anodal Cerebellar tDCS for Multidomain Dysfunctions in Patients With Multiple Sclerosis: A Randomized Controlled Trial Study","CerebellertDCS","Inclusion Criteria:\n\n* Confirmed diagnosis of Multiple Sclerosis according to the revised McDonald criteria\n* Adult Age \\> 18 years\n* Expanded Disability Status Scale (EDSS) score between 2.0 and 6.0\n* Clinically stable disease status for at least 3 months prior to enrollment\n* On stable disease-modifying therapy (DMT) for at least 3 months\n* Ability to understand study procedures and provide informed consent\n* Ability to ambulate independently or with assistive devices sufficient to complete motor assessments\n\nExclusion Criteria:\n\n* Multiple sclerosis relapse within the past 3 months\n* History of epilepsy or seizures\n* Presence of implanted electronic devices (e.g., pacemaker, neurostimulator)\n* Metallic implants in the head or skull incompatible with transcranial magnetic stimulation (TMS)\n* Severe cognitive impairment preventing participation in assessments\n* Pregnancy or planned pregnancy during the study period\n* Other neurological or psychiatric disorders that may confound study outcomes\n* Severe musculoskeletal or orthopedic conditions interfering with motor performance testing\n* Contraindications to non-invasive brain stimulation or TMS","ALL","18 Years",{"count":127,"type":128},40,"ESTIMATED","INTERVENTIONAL",[131],"NA","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.\n\nThe main questions this study aims to answer are the following:\n\nDoes this treatment improve coordination and balance? Does it reduce fatigue and improve sleep and daily life? Does it change brain activity?\n\nResearchers will compare active brain stimulation to sham stimulation (a look-alike treatment that does not deliver real stimulation) to see if the treatment works.\n\nParticipants will:\n\nReceive 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",[134],"Multiple Sclerosis",[136,137,138,139,140,141,142,143,144,145,146,147,148,149,150,151],"Multiple sclerosis","cerebellar transcranial direct current stimulation","ctDCS","bilateral cerebellar stimulation","neuromodulation","ataxia","balance","gait","fatigue","cognition","sleep quality","quality of life","EEG","transcranial magnetic stimulation","corticospinal excitability","neurorehabilitation","NOT_YET_RECRUITING","2026-04-23",{"date":155,"type":156},"2026-04-29","ACTUAL",{"date":158,"type":128},"2026-09-01",{"date":160,"type":128},"2028-06-01",{"name":5,"class":6},1]