Transcranial Direct Current Stimulation for Fatigue, Mood, and Cogniti
Transcranial Direct Current Stimulation for Fatigue, Mood, and Cognition in Multiple Sclerosis: A Randomized, Double-Blind, Sham-Controlled, Crossover Trial
We could not find results for this trial
What it found
We found no results in the registry or in papers.
This trial finished 2 years ago. We found no results in the registry or in any paper that cites it.
What was tested
Treatment tested
- Transcranial Direct Current Stimulation
Placebo
- Sham transcranial direct current stimulation simulation
What it measured
Main measures
Modified Fatigue Impact Scale (MFIS) - Total Score
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)
Thinking and memoryFatigueModified Fatigue Impact Scale (MFIS) - Physical Subscale
Baseline, Day 5, Day 26
FatigueModified Fatigue Impact Scale (MFIS) - Cognitive Subscale
Baseline, Day 5, Day 26
Thinking and memoryFatigueModified Fatigue Impact Scale (MFIS) - Psychosocial Subscale
Baseline, Day 5, Day 26
Fatigue
Other measures (7)
Hospital Anxiety and Depression Scale (HADS) - Anxiety Subscale
Baseline, Day 5, Day 26
Mood and sleepHospital Anxiety and Depression Scale (HADS) - Depression Subscale
Baseline, Day 5, Day 26
Mood and sleepVisual Analog Scale (VAS) - Fatigue
Baseline, Day 5, Day 26
FatigueVisual Analog Scale (VAS) - Depression
Baseline, Day 5, Day 26
Mood and sleepSymbol Digit Modalities Test (SDMT)
Baseline, Day 5, Day 26
Thinking and memoryCalifornia Verbal Learning Test-II (CVLT-II)
Baseline, Day 5, Day 26
Thinking and memoryBrief Visuospatial Memory Test-Revised (BVMT-R)
Baseline, Day 5, Day 26
Thinking and memory
Who could take part
Relapsing and progressive · 18 to 55 · EDSS 0 to 3
Show the full criteria
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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Background
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.Background
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.Background
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 2Background
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.Background
Compston A, Coles A. Multiple sclerosis. Lancet. 2002 Apr 6;359(9313):1221-31. doi: 10.1016/S0140-6736(02)08220-X.
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History
Started
Aug 2023
Main results due
Aug 2024
Finished
Aug 2024