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NCT Number: NCT05951010

Cerebellar Transcranial Direct Current Stimulation in Spinocerebellar Ataxia 38

Spinocerebellar ataxia 38 (SCA 38) is a very rare autosomal dominant inherited disorder caused by a mutation in ELOV5 gene, specifically expressed in cerebellar Purkinje cells, encoding an enzyme involved in the synthesis of fatty acids. The present study aimed to assess the effect of cerebellar anodal transcranial direct current stimulation (tDCS) administered employing deltoid (CD-tDCS) and spinal (CS-tDCS) cathodal montage. Clinical evaluation was performed at baseline (T0), after 15 sessions of tDCS (T1) and after one month of follow-up (T2).

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Key information

Conditions

Spinocerebellar Ataxias Ataxia Brain Diseases Central Nervous System Diseases Cerebellar Ataxia Cerebellar Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dyskinesias Genetic Diseases, Inborn Heredodegenerative Disorders, Nervous System Nervous System Diseases Neurodegenerative Diseases Neurologic Manifestations Spinal Cord Diseases Spinocerebellar Degenerations

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Laboratorio di Biomeccanica ed Ergonomia industriale - Università degli Studi di Cagliari

Monserrato, Cagliari, 09042, Italy

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • age ≤ 80 and > 18 years
  • diagnosis of SCA 38 with the presence of clinical symptoms.

Exclusion criteria

  • Inability to understand and sign the informed consent
  • Presence of other severe neurological disorders
  • presence of significant medical or psychiatric illnesses
  • Pregnancy.

Treatment and study plan

Transcranial Direct Current Stimulation

Device

Anodal stimulation was delivered by a battery-driven stimulator (Neuroelectrics, Barcellona, Spain) through a pair of saline-soaked surface sponge electrodes (7 x 5 cm2) producing a constant current of 2 mA for 20 min. The anode was placed 2 cm under the inion and the cathode was placed over the right deltoid muscle (CD-tDCS) or the spinal lumbar enlargement (2 cm under T11) as described by Benussi et al. (CS-tDCS). An electroconductive gel was applied to the electrodes to reduce contact impedance and the electrodes were held in place using elastic gauzes.

Primary outcomes

  1. Modified International Cooperative Ataxia Rating Scale (MICARS)

    Time frame: Baseline, change after 3 weeks, change after 3 months

    Modified International Cooperative Ataxia Rating Scale (MICARS) was used to rate ataxic symptoms. Scores range from 0 (no impairment) to 100 (maximum impairment) Higher scores indicate worse impairments

  2. Robertson dysarthria profile

    Time frame: Baseline, change after 3 weeks, change after 3 months

    A clinical-perceptual method exploring all components potentially involved in speech difficulties. Minimum score is 0 (higher impairment) maximum score is 284 (no impairments) Higher scores indicate better speech abilties

Secondary outcomes

  1. Gait Speed

    Time frame: Baseline, change after 3 weeks, change after 3 months

    Instrumental assessment of gait speed (m/s) using motion capture system. Higher speed indicate improvements

  2. Step width

    Time frame: Baseline, change after 3 weeks, change after 3 months

    Instrumental assessment of step width (m) using motion capture system. Smaller values of step width indicate gait improvements

  3. Double support phase duration

    Time frame: Baseline, change after 3 weeks, change after 3 months

    Instrumental assessment of double support phase duration (s) using motion capture system. Smaller values of double support phase duration indicate a more stable gait

Sponsors and collaborators

Lead sponsor

University of Cagliari

Other

Collaborators

  • Angela Sanna
  • Chiara Pau
  • Micaela Porta
  • Paolo Tacconi

Registry information

Official study title

Comparison of Two Therapeutic Approaches of Cerebellar Transcranial Direct Current Stimulation in a Sardinian Family Affected by Spinocerebellar Ataxia 38: a Clinical and Computerized 3D Gait Analysis Study.

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 18, 2023
Registry last updated
Jul 18, 2023

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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