Cerebellar Transcranial Direct Current Stimulation in Spinocerebellar Ataxia 38

NCT05951010 | Completed

• 1 other identifier: tDCS-ATX
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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).

Conditions

Spinocerebellar Ataxias

Keywords

gait; ataxic symptoms; dysarthric symptoms

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (3)

• Gait Speed

  Baseline, change after 3 weeks, change after 3 months

• Step width

  Baseline, change after 3 weeks, change after 3 months

• Double support phase duration

  Baseline, change after 3 weeks, change after 3 months

Study Arms (1)

Transcranial direct current stimulation (tDCS)

EXPERIMENTAL

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.

Device: Transcranial Direct Current Stimulation

Interventions

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.

Transcranial direct current stimulation (tDCS)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Cagliari: lead
• Angela Sanna: collaborator
• Micaela Porta: collaborator
• Paolo Tacconi: collaborator
• Chiara Pau: collaborator

Study Sites (1)

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

Monserrato, Cagliari, 09042, Italy

Location

Related Publications (1)

• Sanna A, Pau M, Pilia G, Porta M, Casu G, Secci V, Cartella E, Demattia A, Firinu S, Pau C, Milia A, Cocco E, Tacconi P. 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. Cerebellum. 2024 Jun;23(3):973-980. doi: 10.1007/s12311-023-01590-w. Epub 2023 Aug 4.

  PMID: 37540312 DERIVED

MeSH Terms

Conditions

Spinocerebellar Ataxias

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor of Bioengineering

Study Record Dates

• First Submitted: July 4, 2023
• First Posted: July 18, 2023
• Study Start: November 1, 2022
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: July 18, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)