NCT06873464Enrolling by invitation
Evaluation of the Efficacy of Transcranial Direct Current Stimulation in Reducing Fatigue and Improving Quality of Life in Patients With Multiple Sclerosis: A Randomized Clinical Trial
Source: ClinicalTrials.gov · Last updated 12 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The goal of this clinical trial is to evaluate whether the application of three 2-week cycles of tDCS combined with motor therapy is more effective in reducing fatigue in adult patients with multiple sclerosis, compared to the application of two cycles of the same treatment. The main questions aim to answer: * Is the application of three 2-week cycles of tDCS combined with motor therapy (experimental group) more effective for the recovery of fatigue in adult patients with multiple sclerosis compared to the application of two cycles of the same treatment (control group)? * Is tDCS combined with motor therapy effective in improving fatigue in adult patients with multiple sclerosis in both study arms, i.e., in the pre-post assessment of the experimental group and the pre-post assessment of the control group? Researchers will compare the application of three 2-week cycles of tDCS combined with motor therapy (experimental group) to the application of two cycles of the same treatment (control group) to see if the experimental group shows greater recovery of fatigue in adult patients with multiple sclerosis. Participants will: * Visit the clinic for two weeks to be evaluated (baseline measurement and first post-treatment assessment) and receive the first cycle of treatment from Monday to Friday. * Have a washout period of one month between the first and the second cycle. * Visit the clinic for two weeks to receive the second cycle of treatment and be evaluated (second post-treatment assessment). * Only participants in the experimental group will have another washout period of one month and visit the clinic to receive a third cycle of treatment and to be evaluated (third post-treatment assessment). * Only participants in the control group will visit the clinic one and a half months after completing their second cycle to be measured as a follow-up.
- Status (registry)
- Enrolling by invitation
- Study type
- Interventional
- Enrollment
- 24 (estimated)
- First submitted
- 20 Feb 2025
- Start date
- 20 Feb 2025
- Primary completion date
- 31 Jul 2025
- Lead sponsor
- European University of Madrid
- Diseases
- Multiple sclerosis
- NCT number
- NCT06873464
What you commit to
- Study type: Interventional
- Planned participants: 24
- From 20 Feb 2025 to the primary completion date, 31 Jul 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who are undergoing or need to undergo immunosuppressive treatment for MS with Ocrelizumab, Rituximab, Lemtrada, or Mavenclad one week before or during the application of tDCS.
Other illness
- Patients with contraindications to the use of tDCS, such as: defibrillator, pacemaker, brain stimulator, implanted intracranial metals, skull fractures or fissures, damaged skin or recent scars, epilepsy, pregnancy.
Other
- Patients who have not had stable pharmacological treatment in the last month.
- Patients with cognitive difficulties that prevent them from understanding the applied scales.
- Patients who experience adverse effects from tDCS treatment.
- Inability to remain in the study and complete the third cycle and/or the V3 assessment.
Who the study is looking for
- Patients with multiple sclerosis defined according to the McDonald criteria (2017 revised version).
- Age between 18 and 75 years.
- No relapse in the last 2 months.
- Fatigue experienced in the last 6 months, according to the Fatigue Severity Scale (FSS \> 4).
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fundación Esclerosis Multiple Madrid Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.