Multiple Sclerosis, Relapsing-RemittingREHACOG-MSNCT04261556
tDCS to Enhance Cognitive Training in Multiple Sclerosis
A study testing Real tDCS + CCT in people with Multiple Sclerosis, Relapsing-Remitting, run by University of Milano Bicocca at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis, Relapsing-Remitting
- What is being tested?
- Real tDCS + CCT
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteItaly
- Study dates
- 21 Nov 2019to Dec 2024
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 join
- 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);
- CT/neuromodulation program ongoing or in the preceding 6 months;
- 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;
- Antidepressant/psychoactive drugs in the past 3 months;
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Innovative Protocol Targeting Cognitive Dysfunction in Multiple Sclerosis: tDCS to Enhance Cognitive Training in a Randomized, Double-blind, Controlled, Exploratory Pilot Study
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.
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.
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Being tested
- Real tDCS + CCT, Sham tDCS + CCT
- Keywords
- Multiple sclerosis, Relapsing remitting multiple sclerosis, Cognitive training, Cognitive rehabilitation, Cognitive remediation, Neuromodulation, Transcranial direct current stimulation
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real tDCS + CCTDevice
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, real anodal tDCS and CCT will be provided simultaneously.
Sham tDCS + CCTDevice
40 min/day of computerised cognitive training (CCT) + 20 min/day of apparent (sham) tDCS.
In the first 20 min of the 40 min-intervention, sham tDCS and CCT will be provided simultaneously.
| Study group | Role | What they receive |
|---|---|---|
| Real tDCS + CCT | Experimental | 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. Receives: Device: Real tDCS + CCT |
| Sham tDCS + CCT | Sham comparator | 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. Receives: Device: Sham tDCS + CCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Symbol Digit Modalities Test (SDMT)
Change in target cognitive test assessing information processing (i.e., SDMT)
Measured: Day 0 (baseline, T0), Week 2 (end of treatment, T1), Follow-up at 3 months (FU3) and follow-up at 6 months (FU6)
Change in Paced Auditory Serial Addition Test (PASAT)
Change in target cognitive test assessing information processing (i.e., PASAT)
Measured: Day 0 (baseline, T0), Week 2 (end of treatment, T1), Follow-up at 3 months (FU3) and follow-up at 6 months (FU6)
Change in Wisconsin Card Sorting Test (WCST)
Change in target cognitive test assessing frontal executive functions (i.e., WCST)
Measured: Day 0 (baseline, T0), Week 2 (end of treatment, T1), Follow-up at 3 months (FU3) and follow-up at 6 months (FU6)
Change in Stroop test
Change in target cognitive test assessing frontal executive functions (i.e., Stroop test)
Measured: Day 0 (baseline, T0), Week 2 (end of treatment, T1), Follow-up at 3 months (FU3) and follow-up at 6 months (FU6)
Change in Digit Spans
Change in target cognitive tests assessing information processing and frontal executive functions (i.e., digit spans)
Measured: Day 0 (baseline, T0), Week 2 (end of treatment, T1), Follow-up at 3 months (FU3) and follow-up at 6 months (FU6)
Secondary outcomes (9)
Number of sessions done by esch participants (Feasibility)
Overall compliance of the protocol, assessed by number of sessions done by esch participants (Feasibility)
Measured: Day 0 (baseline, T0), Week 2 (end of treatment, T1)
Number tDCS-related of discomfort or side effects experienced by each participants (Safety)
Any tDCS-related discomfort or side effect after each daily session
Measured: Day 0 (baseline, T0), Week 2 (end of treatment, T1)
Changes in Brief Repeatable Battery of Neuropsychological Tests (BRBN-T)
Changes in single subtest of the BRBN-T
Measured: Day 0 (baseline, T0), Week 2 (end of treatment, T1), Follow-up at 3 months (FU3) and follow-up at 6 months (FU6)
Changes in Beck Depression Inventory (BDI)
21-question multiple-choice self-report inventory, higher score means worse depressive score.
Measured: Day 0 (baseline, T0), Week 2 (end of treatment, T1), Follow-up at 3 months (FU3) and follow-up at 6 months (FU6)
Changes in Expanded Disability Status Scale (EDSS) measurements
10 points scale, higher score means worse disease progression.
Measured: Day 0 (baseline, T0), Week 2 (end of treatment, T1), Follow-up at 3 months (FU3) and follow-up at 6 months (FU6)
Changes in Multiple Sclerosis Functional Composite (MFSC)
Three component parts, higher scores means worse functional symptoms.
Measured: Day 0 (baseline, T0), Week 2 (end of treatment, T1), Follow-up at 3 months (FU3) and follow-up at 6 months (FU6)
Changes in Modified Fatigue Impact Scale (MFIS)
three subscales (physical, cognitive, and psychosocial), as well as into a total MFIS score. higher scores indicate a greater impact of fatigue
Measured: Day 0 (baseline, T0), Week 2 (end of treatment, T1), Follow-up at 3 months (FU3) and follow-up at 6 months (FU6)
Changes in Multiple Sclerosis Quality of Life (MSQOL-54)
Two summary scores - physical health and mental health - can be derived from a weighted combination of scale scores.
Measured: Day 0 (baseline, T0), Week 2 (end of treatment, T1), Follow-up at 3 months (FU3) and follow-up at 6 months (FU6)
Changes in alpha oscillations measured with Electroencephalogram (EEG) Resting State From Baseline
Comparison of alpha oscillation power from resting state EEG recordings on the first and last day of protocol. EEG data also recorded at 3- and 6-month follow up visits. Each of the four EEG recordings will serve to analyze alpha frequency activity for derivation of EEG biomarkers in this observational pilot study.
Measured: Day 0 (baseline, T0), Week 2 (end of treatment, T1), Follow-up at 3 months (FU3) and follow-up at 6 months (FU6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2020
- Study start21 Nov 2019
- Primary completionDec 2023 (estimated)
- Study completionDec 2024 (estimated)
Why it stopped: Due to organizing difficulties after COVID-19 pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Sclerosis, Relapsing-RemittingStudies 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Milano Bicocca
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04261556
- Sponsor's protocol ID
- REHACOG-MS
- Acronym
- REHACOG-MS
- Status last verified
- Dec 2023
- First submitted
- 4 Dec 2019
- Last updated
- 3 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Innovative Protocol Targeting Cognitive Dysfunction in Multiple Sclerosis: tDCS to Enhance Cognitive Training in a Randomized, Double-blind, Controlled, Exploratory Pilot Study
- ClinicalTrials.gov ID
- NCT04261556
- Acronym / sponsor ID
- REHACOG-MS / REHACOG-MS
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Keywords
- Multiple sclerosis, Relapsing remitting multiple sclerosis, Cognitive training, Cognitive rehabilitation, Cognitive remediation, Neuromodulation, Transcranial direct current stimulation
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to organizing difficulties after COVID-19 pandemic
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Milano BicoccaUniversity, hospital or other
- Study start
- 21 Nov 2019 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 10 Feb 2020 (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.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Real tDCS + CCT | Experimental | Device: Real tDCS + CCT40 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 + CCT | Sham comparator | Device: Sham tDCS + CCT40 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (7 listed)
- 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);
- CT/neuromodulation program ongoing or in the preceding 6 months;
- 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;
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 |
|---|---|---|
| Real tDCS + CCT40 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, real anodal tDCS and CCT will be provided simultaneously. | Device | Real tDCS + CCT |
| Sham tDCS + CCT40 min/day of computerised cognitive training (CCT) + 20 min/day of apparent (sham) tDCS. In the first 20 min of the 40 min-intervention, sham tDCS and CCT will be provided simultaneously. | Device | Sham tDCS + CCT |
Primary outcome
Change in Symbol Digit Modalities Test (SDMT)
Time frame: Day 0 (baseline, T0), Week 2 (end of treatment, T1), Follow-up at 3 months (FU3) and follow-up at 6 months (FU6)
Change in target cognitive test assessing information processing (i.e., SDMT)
Change in Paced Auditory Serial Addition Test (PASAT)
Time frame: Day 0 (baseline, T0), Week 2 (end of treatment, T1), Follow-up at 3 months (FU3) and follow-up at 6 months (FU6)
Change in target cognitive test assessing information processing (i.e., PASAT)
Change in Wisconsin Card Sorting Test (WCST)
Time frame: Day 0 (baseline, T0), Week 2 (end of treatment, T1), Follow-up at 3 months (FU3) and follow-up at 6 months (FU6)
Change in target cognitive test assessing frontal executive functions (i.e., WCST)
Change in Stroop test
Time frame: Day 0 (baseline, T0), Week 2 (end of treatment, T1), Follow-up at 3 months (FU3) and follow-up at 6 months (FU6)
Change in target cognitive test assessing frontal executive functions (i.e., Stroop test)
Change in Digit Spans
Time frame: Day 0 (baseline, T0), Week 2 (end of treatment, T1), Follow-up at 3 months (FU3) and follow-up at 6 months (FU6)
Change in target cognitive tests assessing information processing and frontal executive functions (i.e., digit spans)
9 secondary outcomes
Number of sessions done by esch participants (Feasibility)
Time frame: Day 0 (baseline, T0), Week 2 (end of treatment, T1)
Number tDCS-related of discomfort or side effects experienced by each participants (Safety)
Time frame: Day 0 (baseline, T0), Week 2 (end of treatment, T1)
Changes in Brief Repeatable Battery of Neuropsychological Tests (BRBN-T)
Time frame: Day 0 (baseline, T0), Week 2 (end of treatment, T1), Follow-up at 3 months (FU3) and follow-up at 6 months (FU6)
Changes in Beck Depression Inventory (BDI)
Time frame: Day 0 (baseline, T0), Week 2 (end of treatment, T1), Follow-up at 3 months (FU3) and follow-up at 6 months (FU6)
Changes in Expanded Disability Status Scale (EDSS) measurements
Time frame: Day 0 (baseline, T0), Week 2 (end of treatment, T1), Follow-up at 3 months (FU3) and follow-up at 6 months (FU6)
Changes in Multiple Sclerosis Functional Composite (MFSC)
Time frame: Day 0 (baseline, T0), Week 2 (end of treatment, T1), Follow-up at 3 months (FU3) and follow-up at 6 months (FU6)
Changes in Modified Fatigue Impact Scale (MFIS)
Time frame: Day 0 (baseline, T0), Week 2 (end of treatment, T1), Follow-up at 3 months (FU3) and follow-up at 6 months (FU6)
Changes in Multiple Sclerosis Quality of Life (MSQOL-54)
Time frame: Day 0 (baseline, T0), Week 2 (end of treatment, T1), Follow-up at 3 months (FU3) and follow-up at 6 months (FU6)
Changes in alpha oscillations measured with Electroencephalogram (EEG) Resting State From Baseline
Time frame: Day 0 (baseline, T0), Week 2 (end of treatment, T1), Follow-up at 3 months (FU3) and follow-up at 6 months (FU6)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2024.
- Individual participant dataSharing planned: No
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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 Real tDCS + CCT in people with Multiple Sclerosis, Relapsing-Remitting, run by University of Milano Bicocca at 1 site in Italy.
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 7 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: withdrawn, as of the sponsor's last update on 3 Jan 2024. 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 Italy. 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 withdrawn before enrolling participants, so there are no results.
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 Symbol Digit Modalities Test (SDMT) (time frame: Day 0 (baseline, T0), Week 2 (end of treatment, T1), Follow-up at 3 months (FU3) and follow-up at 6 months (FU6)). The study lists 5 primary outcomes in all. 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 3 Jan 2024.