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Completed

NCT Number: NCT05621200

Transcranial Alternating Current Stimulation (tACS) in Patients With Ataxia

The aim of the study is to evaluate the effects on motor and cognitive performance of transcranial alternating current stimulation (tACS) compared to transcranial direct current stimulation (tDCS) and placebo stimulation (sham) in patients with neurodegenerative ataxia to identify a possible rehabilitation protocol.

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Key information

Conditions

Ataxia Ataxia With Oculomotor Apraxia Autonomic Nervous System Diseases Basal Ganglia Diseases Brain Diseases CANVAS Central Nervous System Diseases Cerebellar Ataxia Cerebellar Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dyskinesias Genetic Diseases, Inborn Heredodegenerative Disorders, Nervous System Movement Disorders Multiple System Atrophy Nervous System Diseases Neurodegenerative Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Primary Dysautonomias Signs and Symptoms Spinal Cord Diseases Spinocerebellar Ataxias Spinocerebellar Degenerations Spinocerebellar ataxia, autosomal recessive 1 Synucleinopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ASST Spedali Civili di Brescia

Brescia, BS, 25123, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transcranial stimulation over the cerebellar hemispheres

Device

Single session of Transcranial stimulation over the cerebellar hemispheres

Primary outcomes

  1. Change in the International Cooperative Ataxia Rating Scale (ICARS) Score From Baseline

    Time frame: Baseline (immediately before the intervention) - Immediately after the intervention

    International Cooperative Ataxia Rating Scale (ICARS): semi-quantitative 100-point scale, yielding a total score of 0 (no ataxia) to 100 (most severe ataxia).

  2. Change in the Scale for the Assessment and Rating of Ataxia (SARA) Score From Baseline

    Time frame: Baseline (immediately before the intervention) - Immediately after the intervention

    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).

Secondary outcomes

  1. Change in Cerebellar Brain Inhibition (CBI) Measurements From Baseline

    Time frame: Baseline (immediately before the intervention) - Immediately after the intervention

    Cerebellar brain inhibition (CBI) is expressed as motor evoked potential amplitude (average of 10 recordings). Lower values reflect higher inhibition and thus reduced impairment.

  2. Change in Timed Up and Go Test Duration From Baseline

    Time frame: Baseline (immediately before the intervention) - Immediately after the intervention

    Time (in seconds) that a person takes to rise from a chair, walk three meters, turn around 180 degrees, walk back to the chair, and sit down while turning 180 degrees, assessed with gait sensors.

  3. Change in Walking Cadence From Baseline

    Time frame: Baseline (immediately before the intervention) - Immediately after the intervention

    Average Left and Right Steps/Minute during a 60 seconds walk, assessed with gait sensors.

  4. Change in 360° Turn From Baseline

    Time frame: Baseline (immediately before the intervention) - Immediately after the intervention

    Velocity (Number of Degrees/sec) in making a 360° turn, assessed with gait sensors

Sponsors and collaborators

Lead sponsor

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Other

Registry information

Official study title

Interventional Cross-over Study to Evaluate the Efficacy on Motor and Cognitive Performance of Transcranial Alternating Current Stimulation (tACS) in Patients With Neurodegenerative Ataxia

Acronym: SCAtACS

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 17, 2022
Registry last updated
Dec 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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