Efficacy of tDCS in Degenerative Ataxia

NCT07250321 | Active Not Recruiting

• 1 other identifier: 4642022/CE Study Code tDCS-ATX
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Ataxia, Cerebellar; Ataxia - Genetic Diagnosis - Unknown; Ataxia, Spinocerebellar; Ataxias, Hereditary

Keywords

ataxia; tDCS; non-invasive brain stimulation; gait; upper limb; quantitative analysis

Outcome Measures

Primary Outcomes (1)

• Modified International Cooperative Ataxia Rating Scale (MICARS)

  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. MICARS evaluates key domains such as gait and posture, limb coordination, speech, and eye movements, providing a numerical score that reflects overall ataxia severity. It is commonly used in both clinical practice and research to monitor disease progression and treatment effects in patients with cerebellar ataxia and related disorders.

  Before the first tDCS session (T0) and after 10 sessions (2 weeks)

Secondary Outcomes (2)

• Scale for the Assessment and Rating of Ataxia (SARA)

  Before the first tDCS session (T0) and after 2 weeks (10 sessions)

• Robertson Dysarthria profile

  Befofe the first tDCS session and after 2 weeks (10 sessions)

Study Arms (2)

Sham

SHAM COMPARATOR

For sham stimulation the tDCS device delivered just a short ramp of current to let patients feel a skin sensation similar to those perceived by those actually treated.

Device: Sham (No Treatment)

Real

ACTIVE COMPARATOR

Device: transcranial direct current stimulation

Interventions

transcranial direct current stimulation DEVICE

Anodal stimulation is delivered by a battery-driven stimulator (NeuroConn GmbH, 98693 Ilmenau, Germany) through a pair of saline-soaked surface sponge electrodes (7 x 5 cm2) producing a constant current of 2 mA for 20 min. An electroconductive gel is applied to the electrodes to reduce contact impedance and the electrodes are held in place using elastic gauzes Stimulation is preceded by a ramping up and ramping down for 20 sec at the beginning and at the end of each session, respectively. The anode is placed 2 cm under the inion and the cathode was placed over the right deltoid muscle. For sham stimulation the machine did not deliver any current after the ramping up, so both groups of patients could feel the same skin sensation.

Also known as: Real

Real

Sham (No Treatment) DEVICE

In the "Sham" arm, no current was delivered to the brain except for the initial few seconds

Also known as: Sham

Sham

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• clinical, radiological and/or genetic diagnosis of cerebellar ataxia

You may not qualify if:

• presence of electrical stimulators (i.e., pacemaker), pregnancy, visual disfunction, cognitive decline, mild to moderate ataxic symptoms

Sponsors & Collaborators

• University of Cagliari: lead

Study Sites (1)

University of Cagliari

Cagliari, 09100, Italy

Location

Related Publications (1)

• Sanna A, Pau M, Porta M, Pilia G, Secci V, Cartella E, Demattia A, Paribello A, Cossu G, Milia A, Tacconi P. Efficacy of Cerebellar Transcranial Direct Current Stimulation in Degenerative Ataxia. A Sham-Controlled Clinical and Quantitative Analysis. Cerebellum. 2026 Jan 14;25(1):11. doi: 10.1007/s12311-025-01952-6.

  PMID: 41533249 DERIVED

MeSH Terms

Conditions

Cerebellar Ataxia; Spinocerebellar Ataxias; Spinocerebellar Degenerations; Ataxia

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Cerebellar Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spinal Cord Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor of Bioengineering

Model Details: Sham-controlled study

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: November 26, 2025
• Study Start: October 9, 2023
• Primary Completion: July 21, 2025
• Study Completion: December 1, 2025
• Last Updated: November 26, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: From January 2026 to December 2026
• Access Criteria: Researcher and clinicians involved in ataxia studies

Locations

IT (1)