Multiple Sclerosis Clinical Trial
Official title:
Preventing the Progression of Physical Disability and Promoting Brain Functional Adaptation in People With Multiple Sclerosis: Integration of Early Rehabilitative Treatment and Multimodal Clinical and Instrumental Assessment - Part B
Verified date | July 2023 |
Source | Fondazione Don Carlo Gnocchi Onlus |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
It is widely recognized that physical exercise is safe and people with moderate Multiple Sclerosis (MS) are encouraged to train regularly to improve their skills in motor task execution. Several studies demonstrated that these activities represent an effective low-cost therapy which leads to significant and clinically meaningful improvements in gait and balance in people with MS (PwMS) with mild to moderate walking dysfunction, possibly also by promoting brain plasticity. There is general agreement within the scientific community on the importance of timing intervention also during the early stages of MS to preserve or improve walking and balance abilities and fostering brain functional adaptation, thus slowing down the disease progression. Previous studies highlighted the need to early identify and manage gait disorders using a multimodal approach tailored on individual's need. Moreover, Functional Near-Infrared Spectroscopy (fNIRS) measures blood flow which accompanies neuronal activity and thus, it can provide spatial information about changes in cortical activation patterns due to the possible effects of exercise on cortical plasticity. To the best of the investigators knowledge, no published studies have assessed the effect of exercise on mobility and brain activity in PwMS with minimal or clinically undetectable disability. This emphasizes the need of trials investigating the effect of walking exercise as preventive strategy on MS clinical worsening.
Status | Enrolling by invitation |
Enrollment | 80 |
Est. completion date | January 30, 2025 |
Est. primary completion date | January 30, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion Criteria: - Age > 17 years - Stable disease course (without worsening over 1 point at the Expanded Disability Status Scale in the last 3 months) Exclusion Criteria: - Major depression - Mini-Mental State Examination < 27 - Other cardiovascular or orthopedic diseases that interfere with physical exercise - Progressive course of the disease |
Country | Name | City | State |
---|---|---|---|
Italy | Ospedale Binaghi ASL Cagliari | Cagliari | |
Italy | IRCCS Fondazione Don Carlo Gnocchi | Milan | |
Italy | IRCCS Ospedale San Raffele | Milan |
Lead Sponsor | Collaborator |
---|---|
Fondazione Don Carlo Gnocchi Onlus | Azienda Sanitaria Locale di Cagliari, IRCCS San Raffaele |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Fatigue Severity Scale (FSS) | Is a 9-item self-administered questionnaire to measure the perceived impact of fatigue. The minimum score is 9 and maximum score possible is 63. Higher scores represent greater fatigue severity. If the score is calculated as the mean score of the 9 items, the cut-off score for the presence of the symptom fatigue is set as scores higher than 4. | Baseline, Post, FollowUp_6month | |
Secondary | Differences in oxygenated hemoglobin (Delta oxyHb) | The differences in oxyHb during task period and resting state. Data will be extracted from functional Near InfraRed Spectroscopy (fNIRS) assessment. | Baseline, Post, FollowUp_6month | |
Secondary | Six Minute walking test (6MWT) | Gait asymmetry and regularity extracted from Inertial Measurement Unit's during the six minute walking test. | Baseline, Post, FollowUp_6month | |
Secondary | Number of steps/day | Assessed by activity trackers, a non-invasive method of monitoring human rest/activity cycles. Subjects will be monitored for 1 week wearing an actigraph. | Baseline, Post, FollowUp_6month | |
Secondary | Endurance walking capacity | Assessed as the distance walked over 6 minutes as a sub-maximal test of endurance (6MWT). | Baseline, Post, FollowUp_6month |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05528666 -
Risk Perception in Multiple Sclerosis
|
||
Completed |
NCT03608527 -
Adaptive Plasticity Following Rehabilitation in Multiple Sclerosis
|
N/A | |
Recruiting |
NCT05532943 -
Evaluate the Safety and Efficacy of Allogeneic Umbilical Cord Mesenchymal Stem Cells in Patients With Multiple Sclerosis
|
Phase 1/Phase 2 | |
Completed |
NCT02486640 -
Evaluation of Potential Predictors of Adherence by Investigating a Representative Cohort of Multiple Sclerosis (MS) Patients in Germany Treated With Betaferon
|
||
Completed |
NCT01324232 -
Safety and Efficacy of AVP-923 in the Treatment of Central Neuropathic Pain in Multiple Sclerosis
|
Phase 2 | |
Completed |
NCT04546698 -
5-HT7 Receptor Implication in Inflammatory Mechanisms in Multiple Sclerosis
|
||
Active, not recruiting |
NCT04380220 -
Coagulation/Complement Activation and Cerebral Hypoperfusion in Relapsing-remitting Multiple Sclerosis
|
||
Completed |
NCT02835677 -
Integrating Caregiver Support Into MS Care
|
N/A | |
Completed |
NCT03686826 -
Feasibility and Reliability of Multimodal Evoked Potentials
|
||
Recruiting |
NCT05964829 -
Impact of the Cionic Neural Sleeve on Mobility in Multiple Sclerosis
|
N/A | |
Withdrawn |
NCT06021561 -
Orofacial Pain in Multiple Sclerosis
|
||
Completed |
NCT03653585 -
Cortical Lesions in Patients With Multiple Sclerosis
|
||
Recruiting |
NCT04798651 -
Pathogenicity of B and CD4 T Cell Subsets in Multiple Sclerosis
|
N/A | |
Active, not recruiting |
NCT05054140 -
Study to Evaluate Efficacy, Safety, and Tolerability of IMU-838 in Patients With Progressive Multiple Sclerosis
|
Phase 2 | |
Completed |
NCT05447143 -
Effect of Home Exercise Program on Various Parameters in Patients With Multiple Sclerosis
|
N/A | |
Recruiting |
NCT06195644 -
Effect of Galvanic Vestibular Stimulation on Cortical Excitability and Hand Dexterity in Multiple Sclerosis Patients
|
Phase 1 | |
Completed |
NCT04147052 -
iSLEEPms: An Internet-Delivered Intervention for Sleep Disturbance in Multiple Sclerosis
|
N/A | |
Completed |
NCT03591809 -
Combined Exercise Training in Patients With Multiple Sclerosis
|
N/A | |
Completed |
NCT03594357 -
Cognitive Functions in Patients With Multiple Sclerosis
|
||
Completed |
NCT03269175 -
BENEFIT 15 Long-term Follow-up Study of the BENEFIT and BENEFIT Follow-up Studies
|
Phase 4 |