N/A
N=21
Rehabilitative Trial With Cerebello-Spinal tDCS in Neurodegenerative Ataxia
Ataxia, Cerebellar · Cerebellar Ataxia · Spinocerebellar Ataxias · Ataxia, Spinocerebellar · Spinocerebellar Ataxia Type 1
Bottom Line
View on ClinicalTrials.gov: NCT03120013 ↗Enrolled (actual)
21
Serious AEs
0.0%
Results posted
Jun 2019
Primary outcome: Primary: Change in the International Cooperative Ataxia Rating Scale (ICARS) Score From Baseline — 53.0; 52.7; 43.0; 52.1 units on a scale — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Anodal cerebellar and cathodal spinal tDCS (Device); Sham cerebellar and sham spinal tDCS (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
- Primary completion
- Dec 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in the International Cooperative Ataxia Rating Scale (ICARS) Score From Baseline |
53.0; 52.7; 43.0; 52.1; 41.3; 52.5 | <0.001 sig |
| PRIMARY Change in the Scale for the Assessment and Rating of Ataxia (SARA) Score From Baseline |
20.2; 19.9; 15.8; 19.7; 15.1; 19.7 | <0.001 sig |
| SECONDARY Change in the International Cooperative Ataxia Rating Scale (ICARS) Score From Baseline |
53.0; 52.7; 43.0; 52.1; 41.3; 52.5 | <0.001 sig |
| SECONDARY Change in the Scale for the Assessment and Rating of Ataxia (SARA) Score From Baseline |
20.2; 19.9; 15.8; 19.7; 15.1; 19.7 | <0.001 sig |
| SECONDARY Change in the 9 Hole Peg Test (9HPT) Score From Baseline |
53.0; 52.2; 46.2; 53.4; 47.1; 55.8 | <0.001 sig |
| SECONDARY Change in the 8-Meter Walking Time (8MW) Score From Baseline |
9.4; 9.3; 8.0; 9.0; 7.8; 9.9 | =0.006 sig |
| SECONDARY Change in Cerebellar Brain Inhibition (CBI) Measurements From Baseline |
0.94; 0.88; 0.54; 0.91; 0.65; 0.95 | <0.001 sig |
| SECONDARY Change in the Short-Form Health Survey 36 (SF36) Score From Baseline |
54.7; 55.3; 66.5; 57.9; 66.7; 60.1 | =0.043 sig |
Summary
Neurodegenerative cerebellar ataxias represent a group of disabling disorders for which we currently lack effective therapies. Cerebellar transcranial direct current stimulation (tDCS) is a non-invasive technique, which has been demonstrated to modulate cerebellar excitability and improve symptoms in patients with cerebellar ataxias. In this randomized, double-blind, sham-controlled study, the investigators will evaluate whether a two-weeks' treatment with cerebellar anodal tDCS and spinal cathodal tDCS can improve symptoms in patients with neurodegenerative cerebellar ataxia and can modulate cerebello-motor connectivity, at short and long term.
Eligibility Criteria
Inclusion Criteria
- Patients with a cerebellar syndrome and quantifiable cerebellar atrophy
Exclusion Criteria
- Severe head trauma in the past
- History of seizures
- History of ischemic stroke or hemorrhage
- Pacemaker
- Metal implants in the head/neck region
- Severe comorbidity
- Intake of illegal drugs
- Pregnancy
Data sourced from ClinicalTrials.gov (NCT03120013). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.