Efficacy of tDCS in Degenerative Ataxia

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

Interventions

DEVICE

transcranial direct current stimulation

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.

DEVICE

Sham (No Treatment)

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

Sponsors & Collaborators

• University of Cagliari

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-10-09

Primary Completion

2025-07-21

Completion

2025-12-31

Countries

• Italy

Study Locations