Cerebellar Transcranial Direct Current Stimulation in Spinocerebellar Ataxia 38

NCT ID: NCT05951010

Last Updated: 2023-07-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-01

Study Completion Date

2023-06-01

Brief Summary

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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

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Conditions

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Spinocerebellar Ataxias

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Transcranial direct current stimulation (tDCS)

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.

Group Type EXPERIMENTAL

Transcranial Direct Current Stimulation

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Angela Sanna

UNKNOWN

Sponsor Role collaborator

Micaela Porta

UNKNOWN

Sponsor Role collaborator

Paolo Tacconi

UNKNOWN

Sponsor Role collaborator

Chiara Pau

UNKNOWN

Sponsor Role collaborator

University of Cagliari

OTHER

Sponsor Role lead

Responsible Party

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Massimiliano Pau

Full Professor of Bioengineering

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

Monserrato, Cagliari, Italy

Site Status

Countries

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Italy

References

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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.

Reference Type DERIVED
PMID: 37540312 (View on PubMed)

Other Identifiers

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tDCS-ATX

Identifier Type: -

Identifier Source: org_study_id

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