NCT07250321

Efficacy of Cerebellar Transcranial Direct Current Stimulation in Degenerative Ataxia. A Sham-controlled Clinical and Quantitative Analysis.

Active, enrolled NA Last updated 18 November 2025

What this trial tests

NA trial testing transcranial direct current stimulation in Ataxia, Cerebellar in 16 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

9 October 2023

Primary endpoint
21 July 2025

1 December 2025

Quick facts

Lead sponsor	University of Cagliari
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	16
Start date	9 October 2023
Primary completion	21 July 2025
Estimated completion	1 December 2025
Sites	1 location across Italy

Drugs / interventions tested

• transcranial direct current stimulation
• Sham (No Treatment) — full drug profile →

Conditions studied

• Ataxia, Cerebellar — all drugs for Ataxia, Cerebellar →
• Ataxia - Genetic Diagnosis - Unknown — all drugs for Ataxia - Genetic Diagnosis - Unknown →
• Ataxia, Spinocerebellar — all drugs for Ataxia, Spinocerebellar →
• Ataxias, Hereditary — all drugs for Ataxias, Hereditary →

Sponsor

University of Cagliari

Who can join

Adults 18 to 80, any sex, with Ataxia, Cerebellar or Ataxia - Genetic Diagnosis - Unknown. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Modified International Cooperative Ataxia Rating Scale (MICARS)
  Time frame: Before the first tDCS session (T0) and after 10 sessions (2 weeks)
  The Modified International Cooperative Ataxia Rating Scale (MICARS) is a clinical tool used to assess and quantify the severity of ataxia, a neurological condition characterized by impaired coordination and balance. It is a streamlined version of the original International Cooperative Ataxia Rating Scale (ICARS), designed to improve ease of use, reliability, and sensitivity to clinical changes. MI

Sponsor's own description

Degenerative cerebellar ataxias are a group of rare diseases that cause gradual damage to the cerebellum, the part of the brain that controls balance and coordination. People with these conditions may have difficulty walking, keeping their balance, or coordinating movements. They may also experience vision problems, muscle stiffness, tremors, or changes in behavior, depending on the specific cause of the disease.

These disorders can greatly affect independence and quality of life, and unfortunately, there are currently no treatments that can stop or reverse the disease. Most care focuses on managing symptoms with physical therapy and medication.

Recently, a non-invasive brain stimulation technique called transcranial direct current stimulation (tDCS) has been studied as a possible way to improve movement and thinking in people with ataxia. However, results so far have been mixed, possibly because of differences in disease type, treatment methods, and how improvements are measured.

New technologies, such as motion sensors and movement analysis, are helping researchers better measure the effects of treatments on walking, balance, and hand movements in daily life.

The goal of the current study is to test whether stimulating the cerebellum with anodal tDCS can improve movement in people with different types of degenerative ataxia. The study will use both standard clinical scales and precise movement analysis to measure changes. In addition, researchers will use brain recordings (EEG) taken before and after stimulation to better understand how tDCS may work in the brain

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Efficacy of Cerebellar Transcranial Direct Current Stimulation in Degenerative Ataxia. A Sham-Controlled Clinical and Quantitative Analysis.
   Sanna A, Pau M, Porta M, Pilia G, et al · · 2026 · PMID 41533249 · DOI 10.1007/s12311-025-01952-6