Cerebello-Spinal tDCS as Rehabilitative Intervention in Neurodegenerative Ataxia

Not Applicable

Completed

• Conditions: Spinocerebellar Ataxias; Spinocerebellar Ataxia Type 2; CANVAS; Spinocerebellar Ataxia 3; Multiple System Atrophy; Spinocerebellar Ataxia Type 1; Ataxia; Ataxia With Oculomotor Apraxia
• Interventions: Device: Anodal cerebellar and cathodal spinal tDCS; Device: Sham cerebellar and sham spinal tDCS

• Registration Number: NCT04153110
• Lead Sponsor: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Brief Summary

Neurodegenerative cerebellar ataxias represent a group of disabling disorders which 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 followed by an open-label phase, the investigators will evaluate whether 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.

Detailed 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.

Study Timeline

• Study Start: 2018-12-01
• Study First Submitted: 2019-10-29
• Study First Submitted QC: 2019-11-04
• Study First Posted: 2019-11-06
• Primary Completion: 2020-12-01
• Study Completion: 2021-01-01
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-17
• Last Update Posted: 2021-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Real tDCS - Real tDCS	Anodal cerebellar and cathodal spinal 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 tDCS - Real tDCS	Anodal cerebellar and cathodal spinal 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).
Sham tDCS - Real tDCS	Sham cerebellar and sham spinal 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).

Primary Outcome Measures

Name	Time	Method
Change in the International Cooperative Ataxia Rating Scale (ICARS) Score From Baseline	Baseline - 2 weeks	International Cooperative Ataxia Rating Scale (ICARS): semi-quantitative 100-point scale, yielding a total score of 0 (no ataxia) to 100 (most severe ataxia).
Change in the Scale for the Assessment and Rating of Ataxia (SARA) Score From Baseline	Baseline - 2 weeks	Scale for the Assessment and Rating of Ataxia (SARA): 8-item performance based scale, yielding a total score of 0 (no ataxia) to 40 (most severe ataxia).
Change in the Cerebellar cognitive affective syndrome (CCAS) Scale From Baseline	Baseline - 2 weeks	CCAS/Schmahmann syndrome scale: 120 point scale, yielding a total score of 0 (most severe cognitive impairment) to 120 (no cognitive impairment).

Secondary Outcome Measures

Name	Time	Method
Change in the Short-Form Health Survey 36 (SF36) Score From Baseline	Baseline - 2 weeks - 3 month - 6 months - 9 months	The Italian version of the Short-Form Health Survey 36 (SF-36): consists of 36 scaled score, yielding a total score of 0 (more disability) to 100 (less disability).
Change in the Cerebellar cognitive affective syndrome (CCAS) Scale From Baseline	Baseline - 2 weeks - 3 month - 6 months - 9 months	CCAS/Schmahmann syndrome scale: 120 point scale, yielding a total score of 0 (most severe cognitive impairment) to 120 (no cognitive impairment).
Change in the International Cooperative Ataxia Rating Scale (ICARS) Score From Baseline	Baseline - 2 weeks - 3 month - 6 months - 9 months	International Cooperative Ataxia Rating Scale (ICARS): semi-quantitative 100-point scale, yielding a total score of 0 (no ataxia) to 100 (most severe ataxia).
Change in the Scale for the Assessment and Rating of Ataxia (SARA) Score From Baseline	Baseline - 2 weeks - 3 month - 6 months - 9 months	Scale for the Assessment and Rating of Ataxia (SARA): 8-item performance based scale, yielding a total score of 0 (no ataxia) to 40 (most severe ataxia).
Change in Cerebellar Brain Inhibition (CBI) Measurements From Baseline	Baseline - 2 weeks - 3 month - 6 months - 9 months	Cerebellar brain inhibition (CBI) is expressed as motor evoked potential amplitude (average of 10 recordings). Lower values reflect higher inhibition and thus reduced impairment.

Trial Locations

Locations (1)

AO Spedali Civili; 🇮🇹 Brescia, BS, Italy