Cerebellar Transcranial Direct Current Stimulation in Spinocerebellar Ataxia 38
Primary Purpose
Spinocerebellar Ataxias
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Transcranial Direct Current Stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Spinocerebellar Ataxias focused on measuring gait, ataxic symptoms, dysarthric symptoms
Eligibility Criteria
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.
Sites / Locations
- Laboratorio di Biomeccanica ed Ergonomia industriale - Università degli Studi di Cagliari
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Transcranial direct current stimulation (tDCS)
Arm Description
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.
Outcomes
Primary Outcome Measures
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
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
Secondary Outcome Measures
Gait Speed
Instrumental assessment of gait speed (m/s) using motion capture system. Higher speed indicate improvements
Step width
Instrumental assessment of step width (m) using motion capture system. Smaller values of step width indicate gait improvements
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
Full Information
NCT ID
NCT05951010
First Posted
July 4, 2023
Last Updated
July 10, 2023
Sponsor
University of Cagliari
Collaborators
Angela Sanna, Micaela Porta, Paolo Tacconi, Chiara Pau
1. Study Identification
Unique Protocol Identification Number
NCT05951010
Brief Title
Cerebellar Transcranial Direct Current Stimulation in Spinocerebellar Ataxia 38
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.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
November 1, 2022 (Actual)
Primary Completion Date
June 1, 2023 (Actual)
Study Completion Date
June 1, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cagliari
Collaborators
Angela Sanna, Micaela Porta, Paolo Tacconi, Chiara Pau
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinocerebellar Ataxias
Keywords
gait, ataxic symptoms, dysarthric symptoms
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Transcranial direct current stimulation (tDCS)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Transcranial Direct Current Stimulation
Intervention Description
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 Outcome Measure Information:
Title
Modified International Cooperative Ataxia Rating Scale (MICARS)
Description
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
Time Frame
Baseline, change after 3 weeks, change after 3 months
Title
Robertson dysarthria profile
Description
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
Time Frame
Baseline, change after 3 weeks, change after 3 months
Secondary Outcome Measure Information:
Title
Gait Speed
Description
Instrumental assessment of gait speed (m/s) using motion capture system. Higher speed indicate improvements
Time Frame
Baseline, change after 3 weeks, change after 3 months
Title
Step width
Description
Instrumental assessment of step width (m) using motion capture system. Smaller values of step width indicate gait improvements
Time Frame
Baseline, change after 3 weeks, change after 3 months
Title
Double support phase duration
Description
Instrumental assessment of double support phase duration (s) using motion capture system. Smaller values of double support phase duration indicate a more stable gait
Time Frame
Baseline, change after 3 weeks, change after 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Laboratorio di Biomeccanica ed Ergonomia industriale - Università degli Studi di Cagliari
City
Monserrato
State/Province
Cagliari
ZIP/Postal Code
09042
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
No
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Cerebellar Transcranial Direct Current Stimulation in Spinocerebellar Ataxia 38
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