Amyotrophic Lateral Sclerosis (ALS)
Conditions
Keywords
Amyothrophic Lateral Sclerosis, ALS, tSMS, transcranial magnetic stimulation, NF-L, YKL-40, p75ECD, Biomarkers, transcranial static magnetic stimulation, TDP43
Brief summary
The objective of the present study is to assess the efficacy of tSMS in ALS patients. This will be achieved by monitoring: * levels of NF-L and other potential innovative biomarkers, * clinical progression, trough ALSFRS-R. After at least three-month follow-up, participants will be recruited to undergo biemispheric tSMS for two daily sessions of 120 minutes each, at home, for 12 months. Together with clinical status, which will be evalueted each three months, blood and urine samples will be collected before the start of the tSMS administration (M0) and during the treatment (M3, M6, M9, M12), to detect potential theranostic biomarkers. In a subgroup of patients, ad additional blood and urine sample will be collected 3 months before M0 (M-3). Moreover, cortical excitability will be tested through transcranial magnetic stimulation (TMS) before and after the tSMS stimulation period.
Interventions
DEVICETranscranial magnetic stimulation (tSMS)
Transcranial static magnetic stimulation (tSMS) will be delivered simultaneously to both hemispheres, at the motor cortex (M1), via magnets housed in a helmet.
Sponsors
Campus Bio-Medico University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* age ≥ 18 * diagnosis of possible, probable or definite ALS according to revised El Escorial criteria and Awaji-Shima criteria * disease duration \< 24 months * ALSFRS-R \> 30 at the recruitment * ALSFRS-R decline \> 1 in the at least 3-months period before the intervention * normal respiratory functionality at the preliminary evaluation (M-3), assessed in the previous month (FVC ≥ 75% and ALSFRS-R items 10,11,12 \> 4) * treatment with riluzole 50 mg x 2/die
Exclusion criteria
* inclusion in other clinical trials * presence of tracheotomy or/and PEG (percutaneous endoscopic gastrostomy) * unable to perform spirometry due to severe bulbar involvement * contraindications to magnetic fields exposure * pregnancy or breastfeeding * history of epilepsy or seizures * use of drugs acting on central nervous system, except for antidepressive drugs and benzodiazepines. * cognitive impairment * lack of informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| NfL reduction | 12 months | The potential reduction of NfL during treatment is monitored by blood samples collected at baseline, and then , every 3 months during the treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Monthly Progression Rate (MPR) | 15 months | MPR is derived from the comparison between the ALSFRS-R (Revised Amyotrophic Lateral Sclerosis Functional Rating Scale) decline over the period of at least three months before the treatment, and the period of twelve months during the treatment. The ALSFRS-R is 12-items scale ranking from 0 (worse) to 48 (better) points. |
| New Potential Theranostic Biomarkers Assay | 12 months | Investigation of potential theranostic biomarkers in blood samples (YKL-40, TDP43) and urine samples (p75ECD), collected at baseline and evrey three months during the treatment |
| Effect on resting motor threshold (RMT) and active motor threshold (AMT) | 12 months | Change in TMS-derived cortical excitability parameters (RMT and AMT) before and after stimulation period. |
| Effect on motor evoked potentials (MEP) size | 12 months | Change in TMS-derived cortical excitability parameters (MEP size) before and after stimulation period. |
Countries
Italy
Outcome results
None listed