Relapsing Remitting Multiple SclerosisMScog-tDCSNCT02266121
Improving Cognitive Aptitudes With tDCS in Patients With Multiple Sclerosis
A study testing tDCS in people with Relapsing Remitting Multiple Sclerosis and Secondary-progressive Multiple Sclerosis, run by University Hospital of Mont-Godinne at 1 site in Belgium.
Trial summary
Noninvasive brain stimulations (NIBS) will be used in MS patients with cognitive impairments to enhance their cognitive aptitudes. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Relapsing Remitting Multiple Sclerosis, Secondary-progressive Multiple Sclerosis, Cognitive Deficits
- What is being tested?
- tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- Oct 2014to 8 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- MS patients with relapsing remitting MS/secondary progression MS (based on the 2010 revised McDonald criteria)
- Cognitive deficits
- Motor deficits
Who cannot join
- contraindication to tDCS (seizure or epilepsy, metal in the head, …)
- major psychiatric conditions or major depression
- coexisting instable medical condition
- substance or alcohol abuse
- regular intake of drug that strongly modulate brain excitability
- major sequels from MS preventing participation in the study
- pregnancy
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Department of Neurology, CHU Dinant Godinne UcL Namur
Yvoir, Namur, B-5530
About this study
Official title: Improving Cognitive Aptitudes With tDCS in Patients With Multiple Sclerosis / Améliorer Les capacités Cognitives Par tDCS Chez Les Patients Souffrants de sclérose en Plaques
Noninvasive brain stimulations (NIBS) will be used in MS patients with cognitive impairments to enhance their cognitive aptitudes.
Read the detailed description
tDCS will be used in a sham-controlled, double-blind, randomized, cross-over control trial in MS patients suffering from cognitive impairments and/or motor deficits. After informed consent and recruitment, patients will be randomly (computer method) allocated to real or sham tDCS, that will be applied during working memory and attentional tasks. A few days/weeks after completing one arm, the patients will enter the other arm (double-blind cross-over design).
Baseline and follow-up outcomes about cognitive aptitudes, motor tasks and fatigue will be collected.
- Conditions
- Relapsing Remitting Multiple Sclerosis, Secondary-progressive Multiple Sclerosis, Cognitive Deficits, Motor Deficits
- Being tested
- tDCS
- Keywords
- Multiple Sclerosis, MS, Cognitive deficits, Motor deficits, Fatigue, Nervous System Diseases, Brain Diseases, Brain stimulation, Working memory, Motor learning, Central Nervous System Diseases, Neuropsychological rehabilitation
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis, Chronic Progressive, Cognition Disorders, Neurologic Manifestations, Multiple Sclerosis, Fatigue, Nervous System Diseases, Brain Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCSDevice
Device: transcranial direct current stimulation tDCS tdcs (ELDITH, Neuroconn, Ilmenau, Germany)
| Study group | Role | What they receive |
|---|---|---|
| real tDCS | Active comparator | Patients will receive non-invasive and painless brain stimulation over the rain areas involved in cognitive aptitudes.
tDCS will be applied during 20 minutes while patients will perform attentional, working memory and executive tasks Receives: Device: tDCS |
| Sham tDCS | Placebo comparator | this will be exactly as for "real tDCS" unless that the tDCS will be rapidly turned off, unbeknown from patients-therapist-examinator (double-blind trial) Receives: Device: tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enhancement of Cognitive aptitudes with tDCS
The effect of intervention on attentional, working memory and executive function deficits will be quantified by means of validated tests before and after intervention.
Measured: from baseline to 4 weeks after the intervention
Secondary outcomes (2)
Enhancement of Motor skills with tDCS
Performance on motor skill learning tasks and on different commonly used tasks (Purdue Pegboard, hand dynamometer, pinch dynamometer, 9-HPT, motor skill learning with a videogame, ...) will be measured to explore the impact of tDCS on these parameters in MS patients' population.
Measured: from baseline to 4 weeks after the intervention
Impact on Fatigue and Enhancement of Cognitive performances with tDCS
The effect of intervention on fatigue and performances on the cognitive tasks will be quantified by means of validated questionnaires at inclusion and after tDCS.
Measured: from baseline to 4 weeks after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2014 (estimated)
- Study startOct 2014
- Primary completion8 May 2023
- Study completion8 May 2023
Why it stopped: lack of recruitement
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsing Remitting 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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital of Mont-Godinne
- Sponsor type
- University, hospital or other
- Collaborators
- Université Catholique de Louvain, Teva Pharmaceuticals USA
- Responsible party
- Principal investigator, Pr Yves Vandermeeren, MD, PhD, University Hospital of Mont-Godinne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02266121
- Sponsor's protocol ID
- B039201421534
- Acronym
- MScog-tDCS
- Status last verified
- May 2023
- First submitted
- 10 Oct 2014
- Last updated
- 9 May 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Cognitive Aptitudes With tDCS in Patients With Multiple Sclerosis / Améliorer Les capacités Cognitives Par tDCS Chez Les Patients Souffrants de sclérose en Plaques
- ClinicalTrials.gov ID
- NCT02266121
- Acronym / sponsor ID
- MScog-tDCS / B039201421534
- Conditions
- Relapsing Remitting Multiple Sclerosis, Secondary-progressive Multiple Sclerosis, Cognitive Deficits, Motor Deficits
- Keywords
- Multiple Sclerosis, MS, Cognitive deficits, Motor deficits, Fatigue, Nervous System Diseases, Brain Diseases, Brain stimulation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of recruitement
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital of Mont-GodinneUniversity, hospital or other
- Collaborators
- Université Catholique de Louvain, Teva Pharmaceuticals USA
- Study start
- Oct 2014
- Primary completion
- 8 May 2023 (actual)
- Study completion
- 8 May 2023 (actual)
- First posted
- 16 Oct 2014 (estimated)
- 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.
Noninvasive brain stimulations (NIBS) will be used in MS patients with cognitive impairments to enhance their cognitive aptitudes.
Detailed description
tDCS will be used in a sham-controlled, double-blind, randomized, cross-over control trial in MS patients suffering from cognitive impairments and/or motor deficits. After informed consent and recruitment, patients will be randomly (computer method) allocated to real or sham tDCS, that will be applied during working memory and attentional tasks. A few days/weeks after completing one arm, the patients will enter the other arm (double-blind cross-over design).
Baseline and follow-up outcomes about cognitive aptitudes, motor tasks and fatigue will be collected.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| real tDCS | Active comparator | Device: tDCSPatients will receive non-invasive and painless brain stimulation over the rain areas involved in cognitive aptitudes. tDCS will be applied during 20 minutes while patients will perform attentional, working memory and executive tasks |
| Sham tDCS | Placebo comparator | Device: tDCSthis will be exactly as for "real tDCS" unless that the tDCS will be rapidly turned off, unbeknown from patients-therapist-examinator (double-blind trial) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- MS patients with relapsing remitting MS/secondary progression MS (based on the 2010 revised McDonald criteria)
- Cognitive deficits
- Motor deficits
Key exclusion criteria (7 listed)
- contraindication to tDCS (seizure or epilepsy, metal in the head, …)
- major psychiatric conditions or major depression
- coexisting instable medical condition
- substance or alcohol abuse
- regular intake of drug that strongly modulate brain excitability
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 |
|---|---|---|
| tDCSDevice: transcranial direct current stimulation tDCS tdcs (ELDITH, Neuroconn, Ilmenau, Germany) | Device | Sham tDCS, real tDCS |
Primary outcome
Enhancement of Cognitive aptitudes with tDCS
Time frame: from baseline to 4 weeks after the intervention
The effect of intervention on attentional, working memory and executive function deficits will be quantified by means of validated tests before and after intervention.
2 secondary outcomes
Enhancement of Motor skills with tDCS
Time frame: from baseline to 4 weeks after the intervention
Impact on Fatigue and Enhancement of Cognitive performances with tDCS
Time frame: from baseline to 4 weeks after the intervention
Results and safety
The study was stopped early (reason given: lack of recruitement). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2023.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tDCS in people with Relapsing Remitting Multiple Sclerosis and Secondary-progressive Multiple Sclerosis, run by University Hospital of Mont-Godinne at 1 site in Belgium.
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 3 inclusion and 7 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: stopped early, as of the sponsor's last update on 9 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. 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?
The study was stopped early (reason given: lack of recruitement). Results are not available in the source record.
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?
Enhancement of Cognitive aptitudes with tDCS (time frame: from baseline to 4 weeks after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 May 2023.