---
title: Cerebello-Spinal tDCS as Rehabilitative Intervention in Neurodegenerative Ataxia
nct_id: NCT04153110
overall_status: COMPLETED
phase: NA
sponsor: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
study_type: INTERVENTIONAL
primary_condition: Ataxia
countries: Italy
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT04153110.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04153110"
ct_last_update_post_date: 2021-03-19
last_seen_at: "2026-05-12T06:54:25.314Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Cerebello-Spinal tDCS as Rehabilitative Intervention in Neurodegenerative Ataxia

**Official Title:** Cerebello-Spinal tDCS as Rehabilitative Intervention in Neurodegenerative Ataxias: a Randomized, Double-blind, Sham-controlled Trial Followed by an Open-label Phase

**NCT ID:** [NCT04153110](https://clinicaltrials.gov/study/NCT04153110)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 61
- **Lead Sponsor:** Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
- **Conditions:** Ataxia, Spinocerebellar Ataxias, Spinocerebellar Ataxia Type 1, Spinocerebellar Ataxia Type 2, Spinocerebellar Ataxia 3, Multiple System Atrophy, Ataxia With Oculomotor Apraxia, CANVAS
- **Start Date:** 2018-12-01
- **Completion Date:** 2021-01-01
- **CT.gov Last Update:** 2021-03-19

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

- **Real tDCS - Real tDCS** (EXPERIMENTAL) — 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** (SHAM_COMPARATOR) — 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).

## Interventions

- **Anodal cerebellar and cathodal spinal tDCS** (DEVICE) — 10 sessions of anodal cerebellar and cathodal spinal transcranial direct current stimulation (5 days/week for 2 weeks)
- **Sham cerebellar and sham spinal tDCS** (DEVICE) — 10 sessions of sham cerebellar and sham spinal transcranial direct current stimulation (5 days/week for 2 weeks)

## Primary Outcomes

- **Change in the International Cooperative Ataxia Rating Scale (ICARS) Score From Baseline** _(time frame: 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** _(time frame: 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** _(time frame: 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 Outcomes

- **Change in the International Cooperative Ataxia Rating Scale (ICARS) Score From Baseline** _(time frame: Baseline - 2 weeks - 3 month - 6 months - 9 months)_
- **Change in the Scale for the Assessment and Rating of Ataxia (SARA) Score From Baseline** _(time frame: Baseline - 2 weeks - 3 month - 6 months - 9 months)_
- **Change in the Cerebellar cognitive affective syndrome (CCAS) Scale From Baseline** _(time frame: Baseline - 2 weeks - 3 month - 6 months - 9 months)_
- **Change in Cerebellar Brain Inhibition (CBI) Measurements From Baseline** _(time frame: Baseline - 2 weeks - 3 month - 6 months - 9 months)_
- **Change in the Short-Form Health Survey 36 (SF36) Score From Baseline** _(time frame: Baseline - 2 weeks - 3 month - 6 months - 9 months)_

## Locations (1)

- AO Spedali Civili, Brescia, BS, Italy

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.ao spedali civili|brescia|bs|italy` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT04153110.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT04153110*  
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