New strategies for diagnostic, therapeutic and clinical care in neurological diseases

Neuromodulation strategies to enhance the effects of gait rehabilitation in multiple sclerosis patients with cerebellar ataxia - New strategies in neurological diseases

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-004650-34-IT

Enrollment

Registered

2020-11-05

Start date

2016-06-27

Completion date

Unknown

Last updated

2021-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple sclerosis with cerebellar ataxia MedDRA version: 20.1 Level: PT Classification code 10028245 Term: Multiple sclerosis System Organ Class: 10029205 - Nervous system disorders

Interventions

Trade Name: FAMPYRA - 10 MG - COMPRESSA A RILASCIO PROLUNGATO - USO ORALE - FLACONE (HDPE) 56 COMPRESSE (4 FLACONI DA 14) Pharmaceutical Form: Tablet INN or Proposed INN: FAMPRIDINA CAS Number: 504-24

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Aged 18–70 years, With clinically defined multiple sclerosis (McDonald 2010), Able to complete two trials of the timed 25-foot walk (T25FW) EDSS between 4 and 6, International Cooperative Ataxia Rating Scale (ICARS) walking capacities score =2, Pyramidal Functional System Score (FSS) =2. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 15

Exclusion criteria

Exclusion criteria: Onset of multiple sclerosis exacerbation within 90 days of screening, A history of seizures a history of seizures or the presence of vascular, infectious or methabolic lesions of the cerebral cortex leading to symptomatic seizures, Allergy to pyridine or tablet excipients Patients treated with drugs containing 4-aminopyridine, Any condition that would interfere with the conduct or interpretation of the study, Contraindication to the use of the Transcranial Magnetic Stimulator, Clinically significant abnormal laboratory values or electrocardiogram at screening, Patients with impaired renal function mild, moderate or severe (creatinine cleareance <80 ml/min), Patients treated with OCT2 inhibitors, for example cimetidine, Women were excluded if they were pregnant, lactating or of childbearing potential and not using adequate birth control. We set additional restrictions on changes in concomitant medications to avoid related changes in multiple sclerosis symptoms during the trial.

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the safety and clinical effectiveness of cerebellar TBS and 4-aminopiridine for enhancing the effects of gait rehabilitation;Secondary Objective: To describe the behavioural changes in motor control and learning induced by cerebellar iTBS and by 4-AP, and to detect the associated changes in the cerebello-cortical circuits in multiple sclerosis (MS) patients with CGA;Primary end point(s): we expect to find a >21.43% difference between the treatment (baseline/end of treatment T25FT score ratio: mean 1.4, SD 0.17) and the placebo group (baseline/end of treatment T25FT score ratio: mean 1.1, SD 0.04).;Timepoint(s) of evaluation of this end point: At the end of the two-week experimental treatment period (day 14) with respect to baseline.	—

Measure

Time frame

Main Objective: To evaluate the safety and clinical effectiveness of cerebellar TBS and 4-aminopiridine for enhancing the effects of gait rehabilitation;Secondary Objective: To describe the behavioural changes in motor control and learning induced by cerebellar iTBS and by 4-AP, and to detect the associated changes in the cerebello-cortical circuits in multiple sclerosis (MS) patients with CGA;Primary end point(s): we expect to find a >21.43% difference between the treatment (baseline/end of treatment T25FT score ratio: mean 1.4, SD 0.17) and the placebo group (baseline/end of treatment T25FT score ratio: mean 1.1, SD 0.04).;Timepoint(s) of evaluation of this end point: At the end of the two-week experimental treatment period (day 14) with respect to baseline.

—

Secondary

Measure	Time frame
Secondary end point(s): changes of motor control and learning (saccades adaptation, gait analysis, ICARS, Ashworth score for spasticity, a lower extremity manual muscle test -LEMMT); Changes of fatigue (ocular motor fatigue task, Fatigue Severity Scale - FSS); Changes of functional disability and quality of life (12-item multiple sclerosis walking scale MSWS-12, Activities of Daily Living - ADL, Barthel index - BI, Functional Independence Measure - FIM, Multiple Sclerosis Quality of life inventory - MSQoL-54); Changes of cerebellar-thalamo-cortical inhibition (CBI), parieto-motor functional connection (PPC-M1) short intracortical inhibition (SICI) and intracortical facilitation (ICF), vestibular-spinal tract function (soleus EMG response); Changes of cognitive function (Paced Auditory Serial Addition Task - PASAT, Symbol Digit Modalities Test -SDMT, Controlled Oral Word Association Test, Nine-hole pegboard task). ;Timepoint(s) of evaluation of this end point: The changes will be evaluated at the end of the two-week experimental treatment period (day 14), and at the end of the standard rehabilitation (day 28) and after another four week period (day 56) as follow-up. ; The changes will be evaluated at the end of the two-week experimental treatment period (day 14), and at the end of the standard rehabilitation (day 28) and after another four week period (day 56) as follow-up. ; The changes will be evaluated at the end of the two-week experimental treatment period (day 14), and at the end of the standard rehabilitation (day 28) and after another four week period (day 56) as follow-up. ; The changes will be evaluated at the end of the two-week experimental treatment period (day 14), and at the end of the standard rehabilitation (day 28) and after a	—

Measure

Time frame

Secondary end point(s): changes of motor control and learning (saccades adaptation, gait analysis, ICARS, Ashworth score for spasticity, a lower extremity manual muscle test -LEMMT); Changes of fatigue (ocular motor fatigue task, Fatigue Severity Scale - FSS); Changes of functional disability and quality of life (12-item multiple sclerosis walking scale MSWS-12, Activities of Daily Living - ADL, Barthel index - BI, Functional Independence Measure - FIM, Multiple Sclerosis Quality of life inventory - MSQoL-54); Changes of cerebellar-thalamo-cortical inhibition (CBI), parieto-motor functional connection (PPC-M1) short intracortical inhibition (SICI) and intracortical facilitation (ICF), vestibular-spinal tract function (soleus EMG response); Changes of cognitive function (Paced Auditory Serial Addition Task - PASAT, Symbol Digit Modalities Test -SDMT, Controlled Oral Word Association Test, Nine-hole pegboard task). ;Timepoint(s) of evaluation of this end point: The changes will be evaluated at the end of the two-week experimental treatment period (day 14), and at the end of the standard rehabilitation (day 28) and after another four week period (day 56) as follow-up. ; The changes will be evaluated at the end of the two-week experimental treatment period (day 14), and at the end of the standard rehabilitation (day 28) and after another four week period (day 56) as follow-up. ; The changes will be evaluated at the end of the two-week experimental treatment period (day 14), and at the end of the standard rehabilitation (day 28) and after another four week period (day 56) as follow-up. ; The changes will be evaluated at the end of the two-week experimental treatment period (day 14), and at the end of the standard rehabilitation (day 28) and after a

—

Countries

Italy

Contacts

Public ContactClinical Trial Center

IRCCS Fondazione Istituto Neurologico Nazionale C. Mondino

cinzia.fattore@mondino.it+390382380818

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026