tDCS to Enhance Cognitive Training in Multiple Sclerosis
Key facts
- Who runs it
- University of Milano Bicocca
- Where
- Italy1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Withdrawn
- Started
- 21 Nov 2019
- Ended
- Dec 2024
- Type of study
- Interventional, 2 groupsOne group gets a sham (pretend) treatment, for comparison.
- Treatments tested
- Real tDCS + CCT
- Sham tDCS + CCT
- Record updated
- 3 January 2024
- Why it stopped
- Due to organizing difficulties after COVID-19 pandemic
Who can take part
- Age
- 18 years to 65 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
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Who can take part
- Subjects with clinically definite diagnosis of relapsing remitting MS (RRMS)
- Male or female subjects, 18 to 65 years old
- Expanded Disability Status Scale (EDSS) score ranging from 0 to 5.5 (included)
- Predominant deficits in either attention/information processing
- Fluent Italian speakers
- Normal or corrected-to-normal vision
- Ability to understand the purpose and risk of the study and provide signed informed consent
Who cannot take part
- Antidepressant/psychoactive drugs in the past 3 months
- MS patients in different phase of the disease (as primary/secondary progressive MS; benign MS) or Clinical Isolated Syndrome (CIS) patients
- Exclusive cognitive impairment in different domains (e.g., memory)
- Clinical exacerbations, neuroradiological activity of the disease, modification of EDSS score and disease modifying treatments/steroids during the last 3 months preceding study enrolment
- Significant medical disorders or other major systemic, psychiatric, neurological disorders or alcohol/substance abuse that could interfere with cognitive functioning
- Contraindications to tDCS (intracranial metallic plates, implanted devices, skin disease, superficial injury and fracture or infraction of skull in the stimulation area, epilepsy, pregnancy, etc)
- CT/neuromodulation program ongoing or in the preceding 6 months
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
Expected results: an improvement in cognitive performance in both groups, boosted in the experimental arm and not confined to general frontal-cognitive abilities; potential changes would be reflected also by neurophysiological measures and in QoL.
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Discussion: Investigators hope to provide additional treatment tools for RRMS subjects, with a medium-long term efficacy and an extensive effect. This exploratory pilot study will help to set the rationale for future studies, providing preliminary data useful for selecting the best primary outcome and for calculating a better sample size.
The 2 groups in the trial
- Real tDCS + CCTTreatment being tested
40 min/day of computerised cognitive training (CCT) + 20 min/day of real anodal transcranial direct current stimulation (tDCS). In the first 20 min of the 40 min-intervention, tDCS and CCT will be provided simultaneously.
- Sham tDCS + CCTSham treatment, for comparison
40 min/day of CCT + 20 min/day of apparent (sham) tDCS. In the first 20 min of the 40 min-intervention, tDCS and CCT will be provided simultaneously.
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Innovative Protocol Targeting Cognitive Dysfunction in Multiple Sclerosis: tDCS to Enhance Cognitive Training in a Randomized, Double-blind, Controlled, Exploratory Pilot Study
- Record updated
- 3 January 2024