Multiple SclerosisNCT05462678
Memory Rehabilitation Strategies in Patients With Multiple Sclerosis
A study testing Cognitive Rehabilitation, Combined Rehabilitation and Motor Rehabilitation in people with Multiple Sclerosis, run by I.R.C.C.S. Fondazione Santa Lucia at 2 sites in Italy.
Trial summary
The clinical characteristics of MS are extremely variable from one patient to another. In about 60% of cases, motor disabilities are associated with cognitive deficits. The present study aims to compare three forms of cognitive / motor rehabilitation in three groups of patients with MS: rehabilitation of verbal memory… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Cognitive Rehabilitation, Combined Rehabilitation and Motor Rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesItaly
- Study dates
- 1 Sep 2018to 20 Nov 2021
- 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
- Diagnosis of MS defined according to McDonald's diagnostic criteria revised in 2011.
- RRMS or SPMS phenotype.
- Language Italian mother tongue.
- EDSS score <6.0
Who cannot join
- Neurological or psychiatric pathologies other than MS that can interfere with cognitive functioning
- Clinical relapses in the three months prior to enrollment
- Severe mental illness
- Psychiatric disorders severe enough to interfere with cognitive functioning
- Medications Steroid therapy in the 3 months prior to enrollment
- Motor limitations Upper limb dysfunction (paralysis or tremor) that does not allow to hold the PC mouse
- Sensory limitations Visual acuity impaired enough to not allow reading of the instructions to the various tests
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
Santa Lucia Foundation I.R.C.C.S.
Roma, Rm, 00179
I.R.C.C.S. "Santa Lucia" Foundation
Rome, 00149
About this study
Official title: Strategies and Techniques for the Rehabilitation of Memory Deficits in Patients With Multiple Sclerosis
The clinical characteristics of MS are extremely variable from one patient to another. In about 60% of cases, motor disabilities are associated with cognitive deficits. The present study aims to compare three forms of cognitive / motor rehabilitation in three groups of patients with MS: rehabilitation of verbal memory with the Rehacom program; combined rehabilitation, associating a motor rehabilitation path with the Rehacom program; only motor rehabilitation course. Aims of the study will be: to verify whether the combined cognitive / motor rehabilitation can induce a significantly greater improvement in the memory performance of patients with MS compared to rehabilitation alone; check whether any improvement is objectively verifiable by patients and the impact it may have on patients' quality of life; monitor these effects after 6 months.
For these purposes, three homogeneous groups of 20 patients each will be enrolled, diagnosed with MS according to Mc Donald's criteria revisited by Polman (2011). The study will be divided into an initial clinical, cognitive, emotional, quality of life and functional self-perception (T0) assessment. Subsequently, the patients assigned to the three conditions will be provided with the pre-established rehabilitation treatments for a total duration of 12 weeks; at the end, each patient will undergo an overall re-evaluation (T1). Finally, a further overall reassessment will be carried out after 6 months, aimed at follow-up monitoring (T2).
Read more
Statistical analyzes will be of two types:
Within Group (aimed at assessing any improvement in the cognitive performance of each group of patients by comparing the assessments at T0 with those at T1 and T2); Between Group (aimed at comparing the results obtained by each group with those of the other 2 groups at T0, T1, and T2).
- Conditions
- Multiple Sclerosis
- Being tested
- Cognitive Rehabilitation, Combined Rehabilitation, Motor Rehabilitation
- Keywords
- Cognitive Rehabilitation, Motor Rehabilitation, Cognitive Impairment
- Medical subject headings
- Multiple Sclerosis, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive RehabilitationBehavioural
Each patient performed two weekly sessions of 45 minutes each, for 12 weeks
Combined RehabilitationBehavioural
Each patient performed one session per week (45 minutes) of CR and one session per week of traditional MR training for 12 weeks.
Motor RehabilitationBehavioural
Each patient performed two weekly sessions45 minutes each, for a total of 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Rehabilitation | Experimental | the first group carried out a training of CR by three memory modules of the Rehacom program (http://www.emsmedical.net). Receives: Behavioral: Cognitive Rehabilitation |
| Combined Training | Experimental | the second group followed a mixed training program with the use of the version of the verbal memory module of the Rehacom program combined with the MR training. Receives: Behavioral: Combined Rehabilitation |
| Motor Rehabilitation | Experimental | the third group carried out a traditional MR training. Receives: Behavioral: Motor Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pre- and Post treatment and long term cognitive efficiency
The primary outcome of this study is the scores on the cognitive tasks (Minimal Assessment of Cognitive Functioning in Multiple Sclerosis -MACFIMS). For MACFIMS score ranges from 1 to 3 with higher scores corresponding to higher cognitive impairment.
Measured: 9-months
Secondary outcomes (1)
Pre- and Post-treatment and long term motor efficiency
The secondary outcome of this study is the scores on the gait and balance efficiency scales (Tinetti Scale -TS); For TS the score ranges from 0 to 28 with higher scores corresponding to higher efficiency.
Measured: 9-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2022
- Study start1 Sep 2018
- Primary completion20 Apr 2021
- Study completion20 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- I.R.C.C.S. Fondazione Santa Lucia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ugo Nocentini, MD, Study director, I.R.C.C.S. "Santa Lucia" Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05462678
- Sponsor's protocol ID
- CE/PROG.698
- Status last verified
- Jul 2022
- First submitted
- 4 Jul 2022
- Last updated
- 18 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Argento O, Piacentini C, Bossa M, Caltagirone C, Santamato A, Saraceni V, Nocentini U. Motor, cognitive, and combined rehabilitation approaches on MS patients' cognitive impairment. Neurol Sci. 2023 Mar;44(3):1109-1118. doi: 10.1007/s10072-022-06552-4. Epub 2022 Dec 21.
PubMed 36542204
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strategies and Techniques for the Rehabilitation of Memory Deficits in Patients With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT05462678
- Acronym / sponsor ID
- CE/PROG.698
- Conditions
- Multiple Sclerosis
- Keywords
- Cognitive Rehabilitation, Motor Rehabilitation, Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- I.R.C.C.S. Fondazione Santa LuciaUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 20 Apr 2021 (actual)
- Study completion
- 20 Nov 2021 (actual)
- First posted
- 18 Jul 2022 (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.
The clinical characteristics of MS are extremely variable from one patient to another. In about 60% of cases, motor disabilities are associated with cognitive deficits. The present study aims to compare three forms of cognitive / motor rehabilitation in three groups of patients with MS: rehabilitation of verbal memory with the Rehacom program; combined rehabilitation, associating a motor rehabilitation path with the Rehacom program; only motor rehabilitation course. Aims of the study will be: to verify whether the combined cognitive / motor rehabilitation can induce a significantly greater improvement in the memory performance of patients with MS compared to rehabilitation alone; check whether any improvement is objectively verifiable by patients and the impact it may have on patients' quality of life; monitor these effects after 6 months.
For these purposes, three homogeneous groups of 20 patients each will be enrolled, diagnosed with MS according to Mc Donald's criteria revisited by Polman (2011). The study will be divided into an initial clinical, cognitive, emotional, quality of life and functional self-perception (T0) assessment. Subsequently, the patients assigned to the three conditions will be provided with the pre-established rehabilitation treatments for a total duration of 12 weeks; at the end, each patient will undergo an overall re-evaluation (T1). Finally, a further overall reassessment will be carried out after 6 months, aimed at follow-up monitoring (T2).
Statistical analyzes will be of two types:
Within Group (aimed at assessing any improvement in the cognitive performance of each group of patients by comparing the assessments at T0 with those at T1 and T2); Between Group (aimed at comparing the results obtained by each group with those of the other 2 groups at T0, T1, and T2).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cognitive Rehabilitation | Experimental | Behavioral: Cognitive Rehabilitationthe first group carried out a training of CR by three memory modules of the Rehacom program (http://www.emsmedical.net). |
| Combined Training | Experimental | Behavioral: Combined Rehabilitationthe second group followed a mixed training program with the use of the version of the verbal memory module of the Rehacom program combined with the MR training. |
| Motor Rehabilitation | Experimental | Behavioral: Motor Rehabilitationthe third group carried out a traditional MR training. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of MS defined according to McDonald's diagnostic criteria revised in 2011.
- RRMS or SPMS phenotype.
- Language Italian mother tongue.
- EDSS score <6.0
Key exclusion criteria (7 listed)
- Neurological or psychiatric pathologies other than MS that can interfere with cognitive functioning
- Clinical relapses in the three months prior to enrollment
- Severe mental illness
- Psychiatric disorders severe enough to interfere with cognitive functioning
- Medications Steroid therapy in the 3 months prior to enrollment
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 |
|---|---|---|
| Cognitive RehabilitationEach patient performed two weekly sessions of 45 minutes each, for 12 weeks | Behavioural | Cognitive Rehabilitation |
| Combined RehabilitationEach patient performed one session per week (45 minutes) of CR and one session per week of traditional MR training for 12 weeks. | Behavioural | Combined Training |
| Motor RehabilitationEach patient performed two weekly sessions45 minutes each, for a total of 12 weeks. | Behavioural | Motor Rehabilitation |
Primary outcome
Pre- and Post treatment and long term cognitive efficiency
Time frame: 9-months
The primary outcome of this study is the scores on the cognitive tasks (Minimal Assessment of Cognitive Functioning in Multiple Sclerosis -MACFIMS). For MACFIMS score ranges from 1 to 3 with higher scores corresponding to higher cognitive impairment.
1 secondary outcome
Pre- and Post-treatment and long term motor efficiency
Time frame: 9-months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2022.
- Derived from this study: PubMed 36542204Argento O, Piacentini C, Bossa M, Caltagirone C, Santamato A, Saraceni V, Nocentini U. Motor, cognitive, and combined rehabilitation approaches on MS patients' cognitive impairment. Neurol Sci. 2023 Mar;44(3):1109-1118. doi: 10.1007/s10072-022-06552-4. Epub 2022 Dec 21.
Related trials for Multiple Sclerosis
RecruitingPhase 2
Metformin as an add-on or Monotherapy in Treatment of Aging People With Multiple Sclerosis (MS)
Multiple Sclerosis
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
RecruitingPhase 3
Dalfampridine Combined With Physical Therapy for Mobility Impairment in Multiple Sclerosis
Multiple Sclerosis
RecruitingPhase 2
Targeting Agonists of Glucagon-like Peptide-1 Receptor for Multiple Sclerosis
Multiple Sclerosis
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.
Ugo Nocentini, MD study director
I.R.C.C.S. "Santa Lucia" Foundation
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Rehabilitation, Combined Rehabilitation and Motor Rehabilitation in people with Multiple Sclerosis, run by I.R.C.C.S. Fondazione Santa Lucia at 2 sites 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 4 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: finished, as of the sponsor's last update on 18 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pre- and Post treatment and long term cognitive efficiency (time frame: 9-months). 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 NCT05462678, which also lists 1 linked publication.
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 18 Jul 2022.