Cerebellar Transcranial Direct Current Stimulation in Spinocerebellar Ataxia 38

Not Applicable

Completed

• Conditions: Spinocerebellar Ataxias
• Interventions: Device: Transcranial Direct Current Stimulation

• Registration Number: NCT05951010
• Lead Sponsor: University of Cagliari

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-01
• Primary Completion: 2023-06-01
• Study Completion: 2023-06-01
• Status Verified: 2023-07
• Study First Submitted: 2023-07-04
• Study First Submitted QC: 2023-07-10
• Last Update Submitted: 2023-07-10
• Study First Posted: 2023-07-18
• Last Update Posted: 2023-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Transcranial direct current stimulation (tDCS)	Transcranial Direct Current Stimulation	Participants underwent anodal stimulation 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.

Primary Outcome Measures

Name	Time	Method
Robertson dysarthria profile	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
Modified International Cooperative Ataxia Rating Scale (MICARS)	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

Secondary Outcome Measures

Name	Time	Method
Gait Speed	Baseline, change after 3 weeks, change after 3 months	Instrumental assessment of gait speed (m/s) using motion capture system. Higher speed indicate improvements
Step width	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
Double support phase duration	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

Trial Locations

Locations (1)

Laboratorio di Biomeccanica ed Ergonomia industriale - Università degli Studi di Cagliari; 🇮🇹 Monserrato, Cagliari, Italy