An interventional study of TMS and tDCS in Multiple Sclerosis, sponsored by Universitat Oberta de Catalunya. Enrolling by invitation at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by Universitat Oberta de Catalunya · Not applicable, Interventional, and Treatment
Multiple Sclerosis (MS) is a chronic neurological disease impacting 2.8 million individuals globally, with fatigue being its most debilitating symptom, reported by 75% of patients. Despite its prevalence, the pathophysiology of MS-related fatigue remains poorly understood, and current pharmacological treatments have limited effectiveness. This research addresses this critical gap by investigating two non-invasive brain stimulation (NIBS) techniquestranscranial magnetic stimulation (TMS) and transcranial direct current stimulation (tDCS)as innovative, effective and scalable therapeutic approaches for MS fatigue.
The study employs a parallel, randomized, triple-blind, multicentric, sham-controlled design to assess and compare the short- and long-term efficacy of TMS and tDCS in addressing MS-related fatigue. 80 participants will be recruited from multiple centers in Spain and randomly assigned to one of four experimental groups: TMS, tDCS, Sham-TMS, Sham-tDCS. Each intervention will consist of 20 sessions, conducted daily from Monday to Friday, over 4 weeks. The left dorsolateral prefrontal cortex (DLPFC, F3 following the 10/20 system for EEG) was selected as the stimulation site based on its involvement in MS-related self-reported fatigue and in cognitive fatigability. For TMS experimental groups, intermittent theta-burst protocol (iTBS) will be used to increase the cortical excitability of the stimulated area. iTBS delivers a total of 600 pulses, organised into 50 Hz triplets repeated at 5 Hz, with 2second blocks of pulses, interleaved with 8 seconds of rest, repeated 20 times (total duration: 190s). The intensity of stimulation will be individually tailored based on the active motor threshold (aMT), setting it at 80% of the aMT. The sham stimulation will follow the same protocol, but using a sham coil (placebo). For tDCS experimental groups anodal tDCS will be applied (increasing cortical excitability) with the anode over the left DLPFC (F3), and the cathode over the contralateral supraorbital area. The intensity will be 2mA, and the duration of the stimulation will be 20min per session. For tDCS placebo condition, the sham option available on the device will be selected.
Primary outcomes include changes in fatigue levels measured through MS validated self-report scales (Modified Fatigue Impact Scale-MFIS; Fatigue Scale for Motor and Cognitive Functions-FSMC); secondary outcomes include depression (Beck Depression Inventory-II, BDI-II), quality of life (Multiple Sclerosis Quality of Life, MSQOL-54), functional independence (Functional Independence Measure, FIM), and cognitive fatigability (Symbol Digit Modalities Test, SDMT). All the outcomes will be assessed at baseline, at the end of the intervention, and six months after the end of the treatment (6 months follow-up).
This project promotes personalized precision medicine and innovative new treatment methods. This research is expected to expand scientific knowledge on NIBS efficacy in MS, establish evidence-based clinical practices, and set the foundation for cost-effective, patient-centered therapies. The study also addresses gender-specific responses to treatment, ensuring inclusive therapeutic strategies. Furthermore, it has the potential to benefit other neurological conditions characterized by fatigue, such as stroke, chronic fatigue syndrome or Parkinsons disease, showing significant social, clinical, and economic impact.
3,264 studies on the registry are indexed under Multiple Sclerosis; 659 are open to participants now.
This study's planned enrollment of 80 is above the median of 50 across 2,201 interventional studies indexed under Multiple Sclerosis.
Browse Multiple Sclerosis studies →Universitat Oberta de Catalunya is the lead sponsor of 8 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
iTBS applied over left prefrontal dorsolateral cortex
Device: TMS
Sham iTBS applied over left prefrontal dorsolateral cortex
Device: Sham TMS
tDCS applied over left prefrontal dorsolateral cortex
Device: tDCS
Sham tDCS applied over left prefrontal dorsolateral cortex
Device: Sham tDCS
Intermitent theta burst stimulation over dorsolateral prefrontal cortex
Transcranial direct current stimulation over dorsolateral prefrontal cortex
Sham intermitent theta burst stimulation over dorsolateral prefrontal cortex
Sham transcranial direct current stimulation over dorsolateral prefrontal cortex
Modified Fatigue Impact Scale (MFIS)
The MFIS is a 21-item self-report questionnaire designed to assess how fatigue impacts the daily lives of people living with Multiple Sclerosis (MS). It consists of 21 items divided into three subscales: Physical subscale (9 items)Cognitive subscale (10 items)Psychosocial subscale (2 items). Items are rated based on the patient's experiences over the past 4 weeks using a 5-point Likert scale (from 0 = "Never" to 4 = "Almost always"). Total score ranges from 0 to 84, with higher score indicating more severe fatigue.
Time frame: Baseline, post-treatment (1 month), and 6 months follow-up
Fatigue Scale for Motor and Cognitive Functions (FSMC)
It is a 20-item scale assessing two dimensions of MS-related fatigue: cognitive and motor. Patients rank statements on a scale from "Does not apply" to "Applies completely". Cut-off values were used to classify patients as experiencing mild, moderate or severe fatigue. Higher scores indicating a greater impact of fatigue.
Time frame: Baseline, post-treatment (1 month), and 6 months follow-up
Multiple sclerosis fatigue severity scale (MSFSS)
It is a 9-item (7-point Likert scale), self-report, questionnaire designed to measure the severity of fatigue and its impact on daily activities. It is one of the most widely used and validated scales for patients with Multiple Sclerosis. Higher score Indicates more severe fatigue and interference with the patient's daily responsibilities, work, or social life.
Time frame: Baseline, post-treatment (1 month), and 6 months follow-up
Symbol Digit Modalities Test (SDMT)
The SDMT measures information processing speed, visual scanning, working memory, and sustained attention. It is widely considered the gold standard for detecting and tracking cognitive impairment in patients with Multiple Sclerosis. The total score ranges from 0 to 110, with higher score indicating better cognitive performance.
Time frame: Baseline, post-treatment (1 month), and 6 months follow-up
Multiple Sclerosis Quality of Life (MSQOL-54)
It is a highly comprehensive, disease-specific health-related quality of life instrument designed for patients with Multiple Sclerosis. It consists of 54 items divided into 12 distinct subscales alongside 2 single items.The 12 Subscales: Physical function, role limitations (physical), role limitations (emotional), pain, emotional well-being, energy/fatigue, health perceptions, social function, cognitive function, health distress, sexual function, and satisfaction with sexual function. Total score ranges from 0 to 100, where higher scores indicate a better quality of life.
Time frame: Baseline, post-treatment (1 month), and 6 months follow-up
Functional Independence Measure (FIM)
It is an 18-item clinician-administered assessment designed to measure a patient's level of disability and track their functional changes during rehabilitation. It quantifies how much assistance a person requires to perform essential activities of daily living safely. It is divided into two main subscales: Motor Subscale (13 items): Covers self-care, sphincter control, transfers, and locomotion; and Cognitive Subscale (5 items): Covers communication and social cognition (problem-solving, memory). Total score ranges from 18 to 126. Higher scores indicate greater functional independence.
Time frame: Baseline, post-treatment (1 month), and 6 months follow-up
Barther Index
The Barthel Index is an internationally recognized, clinician-administered or self-report rating scale used to measure a patient's performance in activities of daily living. It consists of 10 items evaluating basic self-care and mobility tasks. The 10 Items: Feeding, bathing, grooming, dressing, bowel control, bladder control, toilet use, transfers (bed to chair), mobility (on level surfaces), and stairs. Total score ranges from 0 to 100; higher scores indicate greater independence.
Time frame: Baseline, post-treatment (1 month), and 6 months follow-up
Selective reminding test (SRT)
The SRT is a highly sensitive neuropsychological verbal memory test designed to assess verbal learning and long-term memory. It is uniquely structured to differentiate between a patient's ability to store information over the long term versus their ability to retrieve it at any given moment. It is widely used to detect cognitive impairment in Multiple Sclerosis. It consists of 6 consecutive learning trials, followed by a delayed recall trial (administered 15 to 30 minutes later) and a final recognition trial. Instead of a single final number, the SRT generates multiple crucial metrics: Long-Term Storage (LTS): The number of words that have entered long-term memory.Consistent Long-Term Retrieval (CLTR): The words consistently recalled across consecutive trials without being reminded.Short-Term Storage (STS): Words recalled only after just being read. Higher scores in all indices indicate better verbal memory and learning capacity.
Time frame: Baseline, post-treatment (1 month), and 6 months follow-up
Spatial recall test (10/36 SPART)
The 10/36 SPART is a highly sensitive neuropsychological test used to evaluate visuospatial learning and long-term visual memory. It includes two different scores: immediate recall ranges from 0 to 30; and delayed recall ranges from 0 to 10. Higher scores always indicate better visuospatial memory.
Time frame: Baseline, post-treatment (1 month), and 6 months follow-up
Paced auditory serial addition task (PASAT)
The PASAT is used to assess auditory information processing speed, sustained attention, divided attention, and working memory. The final score ranges from 0 to 60, with higher scores indicate better processing speed and working memory.
Time frame: Baseline, post-treatment (1 month), and 6 months follow-up
Word List Generation Test (WLG)
The WLG is a brief, widely used verbal fluency test designed to assess a patient's spontaneous word production, executive functioning, and mental flexibility. It includes both phonemic (phonetic) and semantic (categorical) verbal fluency tasks. The final score is simply the total number of correct, unique words produced within the time limit. Higher scores indicate better verbal fluency and executive functioning.
Time frame: Baseline, post-treatment (1 month), and 6 months follow-up
Stroop test
The Stroop Test is used to evaluate executive functioning, specifically selective attention, cognitive flexibility, and processing speed. It measures a person's ability to inhibit an automatic response (reading a word) in favor of a novel, controlled response (naming the ink color). The standard clinical version consists of three separate trials, each presented on a page with columns of items:Word Page (W): Color words (e.g., RED, GREEN, BLUE) printed in black ink. The patient reads the words as fast as possible.Color Page (C): Rows of symbols (like XXXX) printed in colored ink. The patient names the ink colors as fast as possible.Color-Word Page (CW / Interference): Color words printed in conflicting ink colors (e.g., the word RED printed in BLUE ink). The patient must name the color of the ink and ignore the written word. The Interference Score indicate resistance to interferences, with higher scores indicating better cognitive control and stronger resistance to interference.
Time frame: Baseline, post-treatment (1 month), and 6 months follow-up
Trail making test (A and B)
The Trail Making Test (TMT) is a widely used neuropsychological assessment designed to evaluate visuospatial scanning, processing speed, and executive functioning (specifically cognitive flexibility and set-shifting). Part A (TMT-A): The patient is presented with a sheet containing the numbers 1 through 25 scattered inside circles. They must draw a continuous line connecting the numbers in sequential order (1-2-3-4...). It primarily measures visual scanning, motor speed, and basic processing speed. Part B (TMT-B): The patient is presented with numbers (1 to 13) and letters (A to L) scattered inside circles. They must draw a continuous line alternating between numbers and letters in ascending order (1-A-2-B-3-C...). It measures complex executive control, working memory, and cognitive flexibility (set-shifting). The score for each part is the total time in seconds taken to complete the task. Lower times indicate better cognitive performance (faster speed and efficiency).
Time frame: Baseline, post-treatment (1 month), and 6 months follow-up
Hospital anxiety and depression scale (HADS)
The HADS is a widely used 14-item (rated on a 4-point Likert scale, 0 to 3) self-report questionnaire designed to screen for anxiety and depression in patients with physical medical conditions. Its primary methodological advantage is that it strictly excludes somatic symptoms (such as fatigue, pain, or sleep disturbances). This prevents a patient's physical illness-such as Multiple Sclerosis-from artificially inflating their psychological scores. It features two independent subscales of 7 items each:HADS-A (Anxiety): Evaluates cognitive and emotional states of tension, worry, and panic.HADS-D (Depression): Heavily focused on anhedonia (the loss of the ability to enjoy things) rather than physical lethargy. Each subscale is calculated separately and ranges from 0 to 21. Higher scores indicate worse psychological distress.
Time frame: Baseline, post-treatment (1 month), and 6 months follow-up
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Started Sep 2026 (actual). Primary completion is estimated for May 2029, 32 months after the start.
Of 847 non-industry interventional studies with no phase under Multiple Sclerosis, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 43. This study's planned 32 months is above that.
Counting every sponsor, half of 869 studies reached it within 21 months; a quarter within 9 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Universitat Oberta de Catalunya