Multiple SclerosisNCT07567989
Effectiveness of Home-Based Exercise and Brain Stimulation for Reducing Fatigue in Patients With Multiple Sclerosis
A study testing Home-Based Therapeutic Exercise Program and Transcranial Direct Current Stimulation in people with Multiple Sclerosis, run by Jacobo Formigo at 3 sites in Spain.
Trial summary
This randomized, double-blind, parallel-group clinical trial aims to assess the effectiveness of a combined intervention consisting of a home-based therapeutic exercise program and transcranial direct current stimulation (tDCS) for the management of fatigue in patients with multiple sclerosis (MS). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Home-Based Therapeutic Exercise Program and Transcranial Direct Current Stimulation
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 3 sitesSpain
- Study dates
- 1 Jan 2025to 1 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed written informed consent
- Confirmed diagnosis of multiple sclerosis
- Presence of fatigue associated with multiple sclerosis, defined as a fatigue Visual Analogue Scale (VAS) score equal to or greater than 4
- Functional capacity sufficient to perform the Six-Minute Walk Test (6MWT), assessed by a Functional Ambulation Category (FAC) score of 3 or higher
Who cannot join
- Presence of any neurological, rheumatological, or other medical condition prior to the diagnosis of multiple sclerosis that could interfere with the study outcomes
- Presence of contraindications for transcranial direct current stimulation (tDCS), such as having a pacemaker, a history of epillepsy, pregnancy, implanted intracranial electrodes, defibrillator, or similar electronic devices.
- Cognitive impairment that limits the participant's ability to collaborate with study procedures.
- Any changes in physical therapy or pharmacological treatments for multiple sclerosis and/or fatigue that are not specified by the study protocol.
- Occurrence of a multiple sclerosis relapse or disease progression with functional repercussions during the study period.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Spain3 sites
Complexo Hospitalario Universitario de A Coruña
A Coruña, A Coruña, 15009
Complexo Hospitalario Universitario de Santiago de Compostela
Santiago de Compostela, A Coruña, 15706
Complexo Hospitalario Universitario de Vigo
Vigo, Pontevedra, 36214
About this study
Official title: Effectiveness of a Home-Based Therapeutic Exercise Program and Transcranial Direct Current Stimulation (tDCS) as a Treatment for Fatigue in Patients With Multiple Sclerosis
This randomized, double-blind, parallel-group clinical trial aims to assess the effectiveness of a combined intervention consisting of a home-based therapeutic exercise program and transcranial direct current stimulation (tDCS) for the management of fatigue in patients with multiple sclerosis (MS). Fatigue is one of the most disabling and prevalent symptoms in MS, significantly impacting patients' quality of life and functional independence.
Participants diagnosed with MS who meet inclusion criteria will be randomized into two groups:
Read more
Group 1: Home-based therapeutic exercise plus sham (placebo) tDCS
Group 2: Home-based therapeutic exercise plus active tDCS
The intervention will span a defined period, with tDCS sessions applied over the dorsolateral prefrontal cortex (DLPFC) using a standard montage and parameters validated in previous studies. The sham stimulation group will follow identical procedures without active current delivery, preserving blinding for participants and evaluators.
The therapeutic exercise program is designed to be feasible for home implementation, targeting key domains affected in MS such as strength, endurance, balance, and mobility. Exercises will be prescribed based on individual patient assessments and progressively adjusted throughout the intervention period.
Primary outcome measures will include functional capacity, evaluated through the Six-Minute Walk Test (6MWT), and fatigue levels, assessed via the Fatigue Severity Scale (FSS) and a Visual Analogue Scale (VAS) for fatigue. Secondary observations may include adherence rates to the exercise program and subjective reports of tolerability and perceived benefits.
This trial seeks to explore whether combining a physical intervention (exercise) with a neuromodulation technique (tDCS) can offer additive benefits in managing fatigue, beyond what exercise alone provides. The ultimate goal is to develop accessible, non-pharmacological treatment strategies to improve daily functioning and quality of life for individuals living with multiple sclerosis.
Read the detailed description
This study is a randomized, double-blind, controlled clinical trial designed to investigate the efficacy of a combined intervention consisting of a structured home-based therapeutic exercise program and transcranial direct current stimulation (tDCS) for the treatment of fatigue in patients with multiple sclerosis (MS).
Eligible participants will be randomly assigned to one of two parallel groups:
An intervention group receiving a prescribed home-based exercise program in combination with active tDCS.
A control group receiving the same exercise program combined with sham (placebo) tDCS.
The tDCS intervention will target the dorsolateral prefrontal cortex (DLPFC) using a standardized electrode placement, with stimulation parameters based on protocols previously demonstrated to be safe and potentially effective in neurological populations. The sham condition will simulate the sensation of stimulation without delivering an active current, ensuring the integrity of the blinding process for both participants and evaluators.
The therapeutic exercise program will focus on improving muscular strength, cardiovascular endurance, balance, and functional mobility, components known to be affected in individuals with MS. The program will be tailored to individual baseline capabilities and progressively adapted throughout the intervention period to optimize participant engagement and safety.
Primary outcome measures include changes in functional exercise capacity, as assessed by the Six-Minute Walk Test (6MWT), and fatigue severity, evaluated using the Fatigue Severity Scale (FSS) and a Visual Analogue Scale (VAS) for fatigue. Adherence to the intervention and tolerability will also be monitored.
The proposed study addresses a critical need for accessible, non-pharmacological interventions to manage fatigue, one of the most common and disabling symptoms in MS. By combining physical rehabilitation strategies with neuromodulation techniques, the trial aims to determine whether synergistic effects can be achieved, potentially informing future clinical practices aimed at enhancing the quality of life of individuals with multiple sclerosis.
- Conditions
- Multiple Sclerosis
- Being tested
- Home-Based Therapeutic Exercise Program, Transcranial Direct Current Stimulation, Sham tDCS
- Keywords
- Multiple Sclerosis, Fatigue, Home-Based exercise, tDCS, Transcranial Direct Current Stimulation
- Medical subject headings
- Multiple Sclerosis, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-Based Therapeutic Exercise ProgramBehavioural
Participants will engage in a structured home-based therapeutic exercise program administered via a smartphone application. The program consists of targeted strength training, stretching routines, and proprioceptive exercises designed to address functional impairments commonly observed in individuals with multiple sclerosis. Each session will have an approximate duration of 20 to 30 minutes. Participants are required to complete a minimum of three sessions per week for the duration of the intervention phase.
Transcranial Direct Current StimulationDevice
Also called tDCS
Transcranial direct current stimulation (tDCS) targeting the left dorsolateral prefrontal cortex (DLPFC). Stimulation will be delivered using a standard electrode montage, with the anode positioned over the left DLPFC and the cathode over the contralateral supraorbital area. The stimulation parameters will include a current intensity of 1.5 mA applied for 20 minutes per session, with a ramp-up and ramp-down phase of 10 seconds each at the beginning and end of stimulation, respectively. Sessions will be conducted five days per week over a two-week period, for a total of 10 sessions.
Sham tDCSDevice
Also called Sham Transcranial Direct Current Stimulation
Participants assigned to the sham tDCS condition will receive identical electrode placement to the active tDCS group, with the anode over the left dorsolateral prefrontal cortex (DLPFC) and the cathode over the contralateral supraorbital area. The stimulation device will deliver an initial ramp-up phase of 10 seconds of actual stimulation after which no current will be delivered for 1180 seconds, and ending by a ramp-down phase of 10 seconds, The total session duration will match that of the active group (20 minutes), ensuring participant blinding. Sessions will occur five days per week over a two-week period, for a total of 10 sessions.
| Study group | Role | What they receive |
|---|---|---|
| Exercise Plus Active tDCS | Active comparator | Participants assigned to this arm will complete a home-based therapeutic exercise program combined with active transcranial direct current stimulation (tDCS) targeting the dorsolateral prefrontal cortex (DLPFC). Stimulation parameters will follow validated protocols. Participants and outcomes assessors will be blinded to the assignment. Receives: Behavioral: Home-Based Therapeutic Exercise Program; Device: Transcranial Direct Current Stimulation |
| Exercise Plus Sham tDCS | Placebo comparator | Participants assigned to this arm will complete a home-based therapeutic exercise program combined with sham transcranial direct current stimulation (tDCS). Sham stimulation will mimic the sensation of tDCS without delivering an active current. Participants and outcomes assessors will be blinded to the assignment. Receives: Behavioral: Home-Based Therapeutic Exercise Program; Device: Sham tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Fatigue Severity Measured by the Fatigue Severity Scale (FSS)
Fatigue severity will be assessed using the Fatigue Severity Scale (FSS). The primary endpoint is the percentage reduction in the FSS total score compared to baseline. A clinically meaningful improvement is defined as a reduction greater than 20% in the FSS total score (approximately 13 points). Fatigue assessments will be conducted at baseline (prior to the intervention), at 10 days after the final tDCS session, at 3 months, and at 6 months post-intervention to evaluate both immediate and sustained effects.
Measured: Baseline (Day 0), Day 12 (10th and final tDCS session), 3 months from baseline, and 6 months from baseline
Change in Fatigue Severity Measured by Visual Analogue Scale (VAS) for Fatigue
Fatigue severity will be assessed using a Visual Analogue Scale (VAS) for fatigue. The primary endpoint is the change in VAS fatigue score compared to baseline. A clinically meaningful improvement is defined as a reduction of at least 2 points on the VAS. Fatigue assessments will be conducted at baseline (prior to the intervention), at 10 days after the final tDCS session, at 3 months, and at 6 months post-intervention to evaluate both immediate and sustained effect
Measured: Baseline (Day 0), Day 12 (10th and final tDCS session), 3 months from baseline, and 6 months from baseline
Secondary outcomes (1)
Change in Functional Capacity Measured by the Six-Minute Walk Test (6MWT)
The Six-Minute Walk Test (6MWT) will be used to assess participants' functional exercise capacity by recording the total distance walked in six minutes. This test reflects submaximal functional endurance and mobility. Changes in distance walked will be compared to baseline measurements to evaluate improvements.
Measured: Baseline (Day 0), Day 12 (10th and final tDCS session), 3 months from baseline, and 6 months from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2026
- Study start1 Jan 2025
- Primary completion31 Aug 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double-blind, parallel assignment trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jacobo Formigo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jacobo Formigo, Fundación Pública Galega de Investigación Biomédica INIBIC
- Investigators
- Jacobo Formigo, Dr,, Study director, Complexo Hospitalario Universitario de A Coruña
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07567989
- Sponsor's protocol ID
- 2024/103.
- Status last verified
- Apr 2026
- First submitted
- 18 Dec 2025
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Age, sex, fatigue scoring, treatment, exercise adherence
Publications
Linnhoff S, Haghikia A, Zaehle T. Effects of repetitive twice-weekly transcranial direct current stimulations on fatigue and fatigability in people with multiple sclerosis. Sci Rep. 2023 Apr 11;13(1):5878. doi: 10.1038/s41598-023-32779-y.
PubMed 37041183Mortezanejad M, Ehsani F, Masoudian N, Zoghi M, Jaberzadeh S. Comparing the effects of multi-session anodal trans-cranial direct current stimulation of primary motor and dorsolateral prefrontal cortices on fatigue and quality of life in patients with multiple sclerosis: a double-blind, randomized, sham-controlled trial. Clin Rehabil. 2020 Aug;34(8):1103-1111. doi: 10.1177/0269215520921506. Epub 2020 May 12.
PubMed 32397748Bertoli M, Tataranni A, Porziani S, Pasqualetti P, Gianni E, Grifoni J, L'Abbate T, Armonaite K, Conti L, Cancelli A, Cottone C, Marinozzi F, Bini F, Cecconi F, Tecchio F. Effects on Corticospinal Tract Homology of Faremus Personalized Neuromodulation Relieving Fatigue in Multiple Sclerosis: A Proof-of-Concept Study. Brain Sci. 2023 Mar 29;13(4):574. doi: 10.3390/brainsci13040574.
PubMed 37190539Xian C, Barbi C, Goldsworthy MR, Venturelli M, Sidhu SK. The interaction between metaplastic neuromodulation and fatigue in multiple sclerosis. J Neurol Sci. 2023 Jan 15;444:120521. doi: 10.1016/j.jns.2022.120521. Epub 2022 Dec 11.
PubMed 36528976
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Home-Based Therapeutic Exercise Program and Transcranial Direct Current Stimulation (tDCS) as a Treatment for Fatigue in Patients With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT07567989
- Acronym / sponsor ID
- 2024/103.
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, Fatigue, Home-Based exercise, tDCS, Transcranial Direct Current Stimulation
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Jacobo FormigoUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 5 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized, double-blind, parallel-group clinical trial aims to assess the effectiveness of a combined intervention consisting of a home-based therapeutic exercise program and transcranial direct current stimulation (tDCS) for the management of fatigue in patients with multiple sclerosis (MS). Fatigue is one of the most disabling and prevalent symptoms in MS, significantly impacting patients' quality of life and functional independence.
Participants diagnosed with MS who meet inclusion criteria will be randomized into two groups:
Group 1: Home-based therapeutic exercise plus sham (placebo) tDCS
Group 2: Home-based therapeutic exercise plus active tDCS
The intervention will span a defined period, with tDCS sessions applied over the dorsolateral prefrontal cortex (DLPFC) using a standard montage and parameters validated in previous studies. The sham stimulation group will follow identical procedures without active current delivery, preserving blinding for participants and evaluators.
The therapeutic exercise program is designed to be feasible for home implementation, targeting key domains affected in MS such as strength, endurance, balance, and mobility. Exercises will be prescribed based on individual patient assessments and progressively adjusted throughout the intervention period.
Primary outcome measures will include functional capacity, evaluated through the Six-Minute Walk Test (6MWT), and fatigue levels, assessed via the Fatigue Severity Scale (FSS) and a Visual Analogue Scale (VAS) for fatigue. Secondary observations may include adherence rates to the exercise program and subjective reports of tolerability and perceived benefits.
This trial seeks to explore whether combining a physical intervention (exercise) with a neuromodulation technique (tDCS) can offer additive benefits in managing fatigue, beyond what exercise alone provides. The ultimate goal is to develop accessible, non-pharmacological treatment strategies to improve daily functioning and quality of life for individuals living with multiple sclerosis.
Detailed description
This study is a randomized, double-blind, controlled clinical trial designed to investigate the efficacy of a combined intervention consisting of a structured home-based therapeutic exercise program and transcranial direct current stimulation (tDCS) for the treatment of fatigue in patients with multiple sclerosis (MS).
Eligible participants will be randomly assigned to one of two parallel groups:
An intervention group receiving a prescribed home-based exercise program in combination with active tDCS.
A control group receiving the same exercise program combined with sham (placebo) tDCS.
The tDCS intervention will target the dorsolateral prefrontal cortex (DLPFC) using a standardized electrode placement, with stimulation parameters based on protocols previously demonstrated to be safe and potentially effective in neurological populations. The sham condition will simulate the sensation of stimulation without delivering an active current, ensuring the integrity of the blinding process for both participants and evaluators.
The therapeutic exercise program will focus on improving muscular strength, cardiovascular endurance, balance, and functional mobility, components known to be affected in individuals with MS. The program will be tailored to individual baseline capabilities and progressively adapted throughout the intervention period to optimize participant engagement and safety.
Primary outcome measures include changes in functional exercise capacity, as assessed by the Six-Minute Walk Test (6MWT), and fatigue severity, evaluated using the Fatigue Severity Scale (FSS) and a Visual Analogue Scale (VAS) for fatigue. Adherence to the intervention and tolerability will also be monitored.
The proposed study addresses a critical need for accessible, non-pharmacological interventions to manage fatigue, one of the most common and disabling symptoms in MS. By combining physical rehabilitation strategies with neuromodulation techniques, the trial aims to determine whether synergistic effects can be achieved, potentially informing future clinical practices aimed at enhancing the quality of life of individuals with multiple sclerosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, double-blind, parallel assignment trial
| Arm | Type | Receives |
|---|---|---|
| Exercise Plus Active tDCS | Active comparator | Behavioral: Home-Based Therapeutic Exercise Program, Device: Transcranial Direct Current StimulationParticipants assigned to this arm will complete a home-based therapeutic exercise program combined with active transcranial direct current stimulation (tDCS) targeting the dorsolateral prefrontal cortex (DLPFC). Stimulation parameters will follow validated protocols. Participants and outcomes assessors will be blinded to the assignment. |
| Exercise Plus Sham tDCS | Placebo comparator | Behavioral: Home-Based Therapeutic Exercise Program, Device: Sham tDCSParticipants assigned to this arm will complete a home-based therapeutic exercise program combined with sham transcranial direct current stimulation (tDCS). Sham stimulation will mimic the sensation of tDCS without delivering an active current. Participants and outcomes assessors will be blinded to the assignment. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Signed written informed consent
- Confirmed diagnosis of multiple sclerosis
- Presence of fatigue associated with multiple sclerosis, defined as a fatigue Visual Analogue Scale (VAS) score equal to or greater than 4
- Functional capacity sufficient to perform the Six-Minute Walk Test (6MWT), assessed by a Functional Ambulation Category (FAC) score of 3 or higher
Key exclusion criteria (5 listed)
- Presence of any neurological, rheumatological, or other medical condition prior to the diagnosis of multiple sclerosis that could interfere with the study outcomes
- Presence of contraindications for transcranial direct current stimulation (tDCS), such as having a pacemaker, a history of epillepsy, pregnancy, implanted intracranial electrodes, defibrillator, or similar electronic devices.
- Cognitive impairment that limits the participant's ability to collaborate with study procedures.
- Any changes in physical therapy or pharmacological treatments for multiple sclerosis and/or fatigue that are not specified by the study protocol.
- Occurrence of a multiple sclerosis relapse or disease progression with functional repercussions during the study period.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home-Based Therapeutic Exercise ProgramParticipants will engage in a structured home-based therapeutic exercise program administered via a smartphone application. The program consists of targeted strength training, stretching routines, and proprioceptive exercises designed to address functional impairments commonly observed in individuals with multiple sclerosis. Each session will have an approximate duration of 20 to 30 minutes. Participants are required to complete a minimum of three sessions per week for the duration of the intervention phase. | Behavioural | Exercise Plus Active tDCS, Exercise Plus Sham tDCS |
| Transcranial Direct Current StimulationAlso: tDCSTranscranial direct current stimulation (tDCS) targeting the left dorsolateral prefrontal cortex (DLPFC). Stimulation will be delivered using a standard electrode montage, with the anode positioned over the left DLPFC and the cathode over the contralateral supraorbital area. The stimulation parameters will include a current intensity of 1.5 mA applied for 20 minutes per session, with a ramp-up and ramp-down phase of 10 seconds each at the beginning and end of stimulation, respectively. Sessions will be conducted five days per week over a two-week period, for a total of 10 sessions. | Device | Exercise Plus Active tDCS |
| Sham tDCSAlso: Sham Transcranial Direct Current StimulationParticipants assigned to the sham tDCS condition will receive identical electrode placement to the active tDCS group, with the anode over the left dorsolateral prefrontal cortex (DLPFC) and the cathode over the contralateral supraorbital area. The stimulation device will deliver an initial ramp-up phase of 10 seconds of actual stimulation after which no current will be delivered for 1180 seconds, and ending by a ramp-down phase of 10 seconds, The total session duration will match that of the active group (20 minutes), ensuring participant blinding. Sessions will occur five days per week over a two-week period, for a total of 10 sessions. | Device | Exercise Plus Sham tDCS |
Primary outcome
Change in Fatigue Severity Measured by the Fatigue Severity Scale (FSS)
Time frame: Baseline (Day 0), Day 12 (10th and final tDCS session), 3 months from baseline, and 6 months from baseline
Fatigue severity will be assessed using the Fatigue Severity Scale (FSS). The primary endpoint is the percentage reduction in the FSS total score compared to baseline. A clinically meaningful improvement is defined as a reduction greater than 20% in the FSS total score (approximately 13 points). Fatigue assessments will be conducted at baseline (prior to the intervention), at 10 days after the final tDCS session, at 3 months, and at 6 months post-intervention to evaluate both immediate and sustained effects.
Change in Fatigue Severity Measured by Visual Analogue Scale (VAS) for Fatigue
Time frame: Baseline (Day 0), Day 12 (10th and final tDCS session), 3 months from baseline, and 6 months from baseline
Fatigue severity will be assessed using a Visual Analogue Scale (VAS) for fatigue. The primary endpoint is the change in VAS fatigue score compared to baseline. A clinically meaningful improvement is defined as a reduction of at least 2 points on the VAS. Fatigue assessments will be conducted at baseline (prior to the intervention), at 10 days after the final tDCS session, at 3 months, and at 6 months post-intervention to evaluate both immediate and sustained effect
1 secondary outcome
Change in Functional Capacity Measured by the Six-Minute Walk Test (6MWT)
Time frame: Baseline (Day 0), Day 12 (10th and final tDCS session), 3 months from baseline, and 6 months from baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Background: PubMed 37041183Linnhoff S, Haghikia A, Zaehle T. Effects of repetitive twice-weekly transcranial direct current stimulations on fatigue and fatigability in people with multiple sclerosis. Sci Rep. 2023 Apr 11;13(1):5878. doi: 10.1038/s41598-023-32779-y.
- Background: PubMed 32397748Mortezanejad M, Ehsani F, Masoudian N, Zoghi M, Jaberzadeh S. Comparing the effects of multi-session anodal trans-cranial direct current stimulation of primary motor and dorsolateral prefrontal cortices on fatigue and quality of life in patients with multiple sclerosis: a double-blind, randomized, sham-controlled trial. Clin Rehabil. 2020 Aug;34(8):1103-1111. doi: 10.1177/0269215520921506. Epub 2020 May 12.
- Background: PubMed 37190539Bertoli M, Tataranni A, Porziani S, Pasqualetti P, Gianni E, Grifoni J, L'Abbate T, Armonaite K, Conti L, Cancelli A, Cottone C, Marinozzi F, Bini F, Cecconi F, Tecchio F. Effects on Corticospinal Tract Homology of Faremus Personalized Neuromodulation Relieving Fatigue in Multiple Sclerosis: A Proof-of-Concept Study. Brain Sci. 2023 Mar 29;13(4):574. doi: 10.3390/brainsci13040574.
- Background: PubMed 36528976Xian C, Barbi C, Goldsworthy MR, Venturelli M, Sidhu SK. The interaction between metaplastic neuromodulation and fatigue in multiple sclerosis. J Neurol Sci. 2023 Jan 15;444:120521. doi: 10.1016/j.jns.2022.120521. Epub 2022 Dec 11.
- Individual participant dataSharing planned: Yes. Age, sex, fatigue scoring, treatment, exercise adherence
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jacobo Formigo, Dr, study director
Complexo Hospitalario Universitario de A Coruña
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home-Based Therapeutic Exercise Program and Transcranial Direct Current Stimulation in people with Multiple Sclerosis, run by Jacobo Formigo at 3 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Fatigue Severity Measured by the Fatigue Severity Scale (FSS) (time frame: Baseline (Day 0), Day 12 (10th and final tDCS session), 3 months from baseline, and 6 months from baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07567989, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.