Transcranial Direct Current Stimulation for Fatigue, Mood, and Cognition in Multiple Sclerosis
2026년 6월 29일 업데이트: Asdrubal Rene Huerta Gallango, Universidad de Almeria
Transcranial Direct Current Stimulation for Fatigue, Mood, and Cognition in Multiple Sclerosis: A Randomized, Double-Blind, Sham-Controlled, Crossover Trial
Multiple sclerosis (MS) is a chronic, inflammatory and disabling disease of the Cnetral Nervous System characterized by relapsing and / or progressive somatosensory, motor and vestibular clinical manifestations. Moreover, fatigue, depression, anxiety, and cognitive impairment are also present in most MS patients. These symptoms substantially impact quality of life and often show limited response to conventional pharmacological treatment.
Transcranial direct current stimulation (tDCS) is a non-invasive technique that applies a weak direct current to the scalp via surface electrodes, modulating cortical excitability in a polarity-dependent manner.
The objective of this study is to evaluate the efficacy and safety of tDCS for fatigue, depression, anxiety, and cognitive performance in patients with relapsing or progressive MS.
연구 개요
상태
완전한
연구 유형
중재적
등록 (실제)
38
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Mexico City, 멕시코, 11580
- Neurociencia Clínica Integral
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
아니
설명
Inclusion Criteria:
- Age 18-55 years at the time of enrollment
- Clinical diagnosis of Relapsing Multiple Sclerosis (RMS) or Progressive Multiple Sclerosis (PMS), with or without active progression, established per the 2014 McDonald diagnostic criteria
- Expanded Disability Status Scale (EDSS) score of 0-3 at the time of screening
- Time since initial MS diagnosis of at least 6 months
- Active fatigue symptoms reported by the participant for at least the 6 months prior to enrollment
Exclusion Criteria:
- History of neuropsychiatric illness (including major depression, bipolar disorder, schizophrenia, or any anxiety disorder) prior to the onset of multiple sclerosis
- Diagnosis of neuromyelitis optica spectrum disorder (Devic's disease)
- Presence of any other central nervous system disease
- Disease duration greater than 10 years combined with an EDSS score of ≤ 2
- Visual impairment secondary to optic neuritis, internuclear ophthalmoplegia (oculomotor disorder), or any other uncorrected visual impairment that would affect task performance on cognitive assessments
- Current pharmacological treatment for fatigue or depression
- Current neuropsychiatric pharmacological treatment, including any antidepressant, anxiolytic, neuroleptic, or anticonvulsant medication
- Clinical relapse requiring corticosteroid treatment in the 3 months prior to enrollment
- Severe upper-limb motor deficit that would prevent task performance on neuropsychological assessments
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Active, F3 anode, F4 cathode, 20 minutes, 4 mA, transcranial direct current stimulation
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Transcranial direct current stimulation (tDCS) is a non-invasive technique that applies a weak direct current to the scalp via surface electrodes, modulating cortical excitability in a polarity-dependent manner.
tDCS has an established safety profile across the populations and protocols studied to date.
This study uses an anodal stimulation montage of the dorsolateral prefrontal cortex (DLPFC).
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가짜 비교기: Sham, F3 anode, F4 cathode, 20 minutes, 0 mA, transcranial direct current stimulation simulation
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Sham Comparator: Sham, F3 anode, F4 cathode, 20 minutes, transcranial direct current stimulation simulation
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Modified Fatigue Impact Scale (MFIS) - Total Score
기간: Assessed at baseline (Day 0), immediately following the first 5-day stimulation block (Day 5), and immediately following the second 5-day stimulation block (Day 26 after washout)
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The MFIS is a 21-item multidimensional self-report scale assessing the impact of fatigue on physical (9 items), cognitive (10 items), and psychosocial (2 items) functioning over the past 4 weeks.
Each item is scored 0-4; total score ranges from 0 to 84.
Higher scores indicate greater fatigue impact.
The primary comparison is post-active-tDCS total score versus post-sham total score.
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Assessed at baseline (Day 0), immediately following the first 5-day stimulation block (Day 5), and immediately following the second 5-day stimulation block (Day 26 after washout)
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Modified Fatigue Impact Scale (MFIS) - Physical Subscale
기간: Baseline, Day 5, Day 26
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Physical subscale of the MFIS (9 items; range 0-36).
Assesses impact of fatigue on physical functioning.
Compared between active tDCS and sham conditions.
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Baseline, Day 5, Day 26
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Modified Fatigue Impact Scale (MFIS) - Cognitive Subscale
기간: Baseline, Day 5, Day 26
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Cognitive subscale of the MFIS (10 items; range 0-40).
Assesses impact of fatigue on cognitive functioning.
Compared between active tDCS and sham conditions.
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Baseline, Day 5, Day 26
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Modified Fatigue Impact Scale (MFIS) - Psychosocial Subscale
기간: Baseline, Day 5, Day 26
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Psychosocial subscale of the MFIS (2 items; range 0-8).
Assesses impact of fatigue on psychosocial functioning.
Compared between active tDCS and sham conditions.
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Baseline, Day 5, Day 26
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Hospital Anxiety and Depression Scale (HADS) - Anxiety Subscale
기간: Baseline, Day 5, Day 26
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7-item subscale of the HADS assessing anxiety symptom severity.
Each item is scored 0-3; subscale range 0-21.
Higher scores indicate greater anxiety.
Compared between active tDCS and sham conditions.
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Baseline, Day 5, Day 26
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Hospital Anxiety and Depression Scale (HADS) - Depression Subscale
기간: Baseline, Day 5, Day 26
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7-item subscale of the HADS assessing depression symptom severity.
Each item is scored 0-3; subscale range 0-21.
Higher scores indicate greater depression.
Compared between active tDCS and sham conditions.
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Baseline, Day 5, Day 26
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Visual Analog Scale (VAS) - Fatigue
기간: Baseline, Day 5, Day 26
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Participant-rated 0-10 point visual analog scale for subjective fatigue severity (0 = no fatigue, 10 = worst imaginable fatigue).
Used as a brief supplementary measure alongside the MFIS.
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Baseline, Day 5, Day 26
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Visual Analog Scale (VAS) - Depression
기간: Baseline, Day 5, Day 26
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Participant-rated 0-10 point visual analog scale for subjective depression severity (0 = no depression, 10 = worst imaginable depression).
Used as a brief supplementary measure alongside the HADS.
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Baseline, Day 5, Day 26
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Symbol Digit Modalities Test (SDMT)
기간: Baseline, Day 5, Day 26
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Validated test of information-processing speed and working memory, part of the Brief International Cognitive Assessment for MS (BICAMS).
The participant substitutes symbols for digits within 90 seconds; higher scores indicate better performance.
Compared between active tDCS and sham conditions.
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Baseline, Day 5, Day 26
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California Verbal Learning Test-II (CVLT-II)
기간: Baseline, Day 5, Day 26
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Standardized measure of short-term verbal learning and memory, part of the BICAMS battery.
Assessed as total correct recall across learning trials; higher scores indicate better performance.
Compared between active tDCS and sham conditions.
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Baseline, Day 5, Day 26
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Brief Visuospatial Memory Test-Revised (BVMT-R)
기간: Baseline, Day 5, Day 26
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Standardized measure of short-term visuospatial memory and learning, part of the BICAMS battery.
Assessed as total correct recall across learning trials; higher scores indicate better performance.
Compared between active tDCS and sham conditions.
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Baseline, Day 5, Day 26
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Adverse events - frequency and type
기간: After each of the 10 stimulation sessions (Days 1-5 and Days 22-26)
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Adverse events assessed by structured interview after each stimulation session, including tingling, stinging, burning, headache, dizziness, numbness, forgetfulness, difficulty concentrating, blurred vision, muscle spasms, nausea, and difficulty breathing.
Frequencies compared between active and sham conditions using McNemar's test.
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After each of the 10 stimulation sessions (Days 1-5 and Days 22-26)
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: ASDRUBAL R HUERTA GALLANGO, MD / PhD, Universidad de Almeria
- 수석 연구원: Luis Fernando Sánchez-Santed, PhD, Universidad de Almeria
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- Bikson M, Grossman P, Thomas C, Zannou AL, Jiang J, Adnan T, Mourdoukoutas AP, Kronberg G, Truong D, Boggio P, Brunoni AR, Charvet L, Fregni F, Fritsch B, Gillick B, Hamilton RH, Hampstead BM, Jankord R, Kirton A, Knotkova H, Liebetanz D, Liu A, Loo C, Nitsche MA, Reis J, Richardson JD, Rotenberg A, Turkeltaub PE, Woods AJ. Safety of Transcranial Direct Current Stimulation: Evidence Based Update 2016. Brain Stimul. 2016 Sep-Oct;9(5):641-661. doi: 10.1016/j.brs.2016.06.004. Epub 2016 Jun 15.
- Stagg CJ, Antal A, Nitsche MA. Physiology of Transcranial Direct Current Stimulation. J ECT. 2018 Sep;34(3):144-152. doi: 10.1097/YCT.0000000000000510.
- Benedict RH, Amato MP, Boringa J, Brochet B, Foley F, Fredrikson S, Hamalainen P, Hartung H, Krupp L, Penner I, Reder AT, Langdon D. Brief International Cognitive Assessment for MS (BICAMS): international standards for validation. BMC Neurol. 2012 Jul 16;12:55. doi: 10.1186/1471-2377-12-55.
- Hsu WY, Cheng CH, Zanto TP, Gazzaley A, Bove RM. Effects of Transcranial Direct Current Stimulation on Cognition, Mood, Pain, and Fatigue in Multiple Sclerosis: A Systematic Review and Meta-Analysis. Front Neurol. 2021 Mar 8;12:626113. doi: 10.3389/fneur.2021.626113. eCollection 2021.
- Compston A, Coles A. Multiple sclerosis. Lancet. 2002 Apr 6;359(9313):1221-31. doi: 10.1016/S0140-6736(02)08220-X.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2023년 8월 1일
기본 완료 (실제)
2024년 8월 30일
연구 완료 (실제)
2024년 8월 30일
연구 등록 날짜
최초 제출
2026년 6월 23일
QC 기준을 충족하는 최초 제출
2026년 6월 29일
처음 게시됨 (실제)
2026년 7월 2일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 7월 2일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 6월 29일
마지막으로 확인됨
2026년 6월 1일
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- TDCSMS-001
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
De-identified individual participant data (IPD) underlying the results reported in the published article will be made available to qualified researchers upon reasonable request.
Shared data will include the de-identified clinical dataset (outcome scores at baseline, post-sham, and post-treatment time points for all 33 completers), the statistical analysis plan, and the data dictionary.
Requests should be directed to the corresponding author (asdrubalhuerta@gmail.com)
and will be reviewed on a case-by-case basis.
Data will be shared after deposition of the dataset in an institutional or public repository upon publication of the primary manuscript.
IPD 공유 기간
Starting 3 months following publication of the primary manuscript; available for at least 5 years thereafter.
IPD 공유 액세스 기준
Researchers with a methodologically sound research proposal and a signed data access agreement with the corresponding institution.
Requests submitted to the corresponding author.
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ICF
- ANALYTIC_CODE
- CSR
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
미국에서 제조되어 미국에서 수출되는 제품
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .