Cerebello-Spinal tDCS as Rehabilitative Intervention in Neurodegenerative Ataxia
Keywords
Abstract
Description
Neurodegenerative cerebellar ataxias represent a heterogeneous group of disabling disorders in which progressive ataxia of gait, limb dysmetria, oculomotor deficits, dysarthria and kinetic tremor are the prominent clinical manifestations. Both the hereditary and sporadic forms usually present in young adulthood, and are characterized by atrophy of cerebellar or brainstem structures. Currently, cerebellar ataxia lack effective disease-modifying 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. The present randomized, double-blind, sham-controlled study followed by an open-label phase will investigate a repetition of two-weeks' treatment with cerebellar anodal tDCS and spinal cathodal tDCS, after a three months interval, may further outlast clinical improvement in patients with neurodegenerative cerebellar ataxia and can modulate cerebello-motor connectivity, at short and long term. In addition the investigators will evaluate if tDCS intervention might improve cerebellar cognitive-affective syndrome in patients with ataxia.
Dates
| Last Verified: | 02/29/2020 |
| First Submitted: | 10/28/2019 |
| Estimated Enrollment Submitted: | 11/03/2019 |
| First Posted: | 11/05/2019 |
| Last Update Submitted: | 02/29/2020 |
| Last Update Posted: | 03/02/2020 |
| Actual Study Start Date: | 11/30/2018 |
| Estimated Primary Completion Date: | 08/31/2020 |
| Estimated Study Completion Date: | 12/31/2020 |
Condition or disease
Intervention/treatment
Device: Anodal cerebellar and cathodal spinal tDCS
Device: Sham tDCS - Real tDCS
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Experimental: Real tDCS - Real tDCS 10 sessions of anodal cerebellar and cathodal spinal transcranial direct current stimulation (5 days/week for 2 weeks) followed by an open-label 10 sessions of anodal cerebellar and cathodal spinal transcranial direct current stimulation (5 days/week for 2 weeks) | |
| Sham Comparator: Sham tDCS - Real tDCS 10 sessions of sham cerebellar and sham spinal transcranial direct current stimulation (5 days/week for 2 weeks) followed by an open-label 10 sessions of anodal cerebellar and cathodal spinal transcranial direct current stimulation (5 days/week for 2 weeks). | Device: Sham tDCS - Real tDCS 10 sessions of sham cerebellar and sham spinal transcranial direct current stimulation (5 days/week for 2 weeks) |
Eligibility Criteria
| Ages Eligible for Study | 18 Years To 18 Years |
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | Yes |
| 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 |
Outcome
Primary Outcome Measures
1. Change in the International Cooperative Ataxia Rating Scale (ICARS) Score From Baseline [Baseline - 2 weeks]
2. Change in the Scale for the Assessment and Rating of Ataxia (SARA) Score From Baseline [Baseline - 2 weeks]
3. Change in the Cerebellar cognitive affective syndrome (CCAS) Scale From Baseline [Baseline - 2 weeks]
Secondary Outcome Measures
1. Change in the International Cooperative Ataxia Rating Scale (ICARS) Score From Baseline [Baseline - 2 weeks - 3 month - 6 months - 9 months]
2. Change in the Scale for the Assessment and Rating of Ataxia (SARA) Score From Baseline [Baseline - 2 weeks - 3 month - 6 months - 9 months]
3. Change in the Cerebellar cognitive affective syndrome (CCAS) Scale From Baseline [Baseline - 2 weeks - 3 month - 6 months - 9 months]
4. Change in Cerebellar Brain Inhibition (CBI) Measurements From Baseline [Baseline - 2 weeks - 3 month - 6 months - 9 months]
5. Change in the Short-Form Health Survey 36 (SF36) Score From Baseline [Baseline - 2 weeks - 3 month - 6 months - 9 months]
