Cerebellar Transcranial Direct Current Stimulation in Spinocerebellar Ataxia 38

Spinocerebellar Ataxias Clinical Trial

Official 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05951010
• Other study ID #: tDCS-ATX
• Status: Completed
• Phase: N/A
• Start date: November 1, 2022
• Est. completion date: June 1, 2023

Study information

• Verified date: July 2023
• Source: University of Cagliari
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: June 1, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. age = 80 and > 18 years

2. diagnosis of SCA 38 with the presence of clinical symptoms.

Exclusion Criteria:

1. Inability to understand and sign the informed consent

2. Presence of other severe neurological disorders

3. presence of significant medical or psychiatric illnesses

4. Pregnancy.

Related Conditions & MeSH terms

• Ataxia
• Cerebellar Ataxia
• Spinocerebellar Ataxias
• Spinocerebellar Degenerations

Intervention

Device:
• Transcranial Direct Current Stimulation
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.

Locations

Country	Name	City	State
Italy	Laboratorio di Biomeccanica ed Ergonomia industriale - Università degli Studi di Cagliari	Monserrato	Cagliari

Sponsors (5)

Lead Sponsor	Collaborator
University of Cagliari	Angela Sanna, Chiara Pau, Micaela Porta, Paolo Tacconi

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Modified International Cooperative Ataxia Rating Scale (MICARS)	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	Baseline, change after 3 weeks, change after 3 months
Primary	Robertson dysarthria profile	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	Baseline, change after 3 weeks, change after 3 months
Secondary	Gait Speed	Instrumental assessment of gait speed (m/s) using motion capture system. Higher speed indicate improvements	Baseline, change after 3 weeks, change after 3 months
Secondary	Step width	Instrumental assessment of step width (m) using motion capture system. Smaller values of step width indicate gait improvements	Baseline, change after 3 weeks, change after 3 months
Secondary	Double support phase duration	Instrumental assessment of double support phase duration (s) using motion capture system. Smaller values of double support phase duration indicate a more stable gait	Baseline, change after 3 weeks, change after 3 months