Spinocerebellar AtaxiasNCT05951010
Cerebellar Transcranial Direct Current Stimulation in Spinocerebellar Ataxia 38
A study testing Transcranial Direct Current Stimulation in people with Spinocerebellar Ataxias, run by University of Cagliari at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Spinocerebellar Ataxias
- What is being tested?
- Transcranial Direct Current Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteItaly
- Study dates
- 1 Nov 2022to 1 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age ≤ 80 and > 18 years
- diagnosis of SCA 38 with the presence of clinical symptoms.
Who cannot join
- Inability to understand and sign the informed consent
- Presence of other severe neurological disorders
- presence of significant medical or psychiatric illnesses
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Laboratorio di Biomeccanica ed Ergonomia industriale - Università degli Studi di Cagliari
Monserrato, Cagliari, 09042
About this study
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.
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
- Being tested
- Transcranial Direct Current Stimulation
- Keywords
- gait, ataxic symptoms, dysarthric symptoms
- Medical subject headings
- Spinocerebellar Ataxias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Direct Current StimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Transcranial Direct Current Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Baseline, change after 3 weeks, change after 3 months
Secondary outcomes (3)
Gait Speed
Instrumental assessment of gait speed (m/s) using motion capture system. Higher speed indicate improvements
Measured: Baseline, change after 3 weeks, change after 3 months
Step width
Instrumental assessment of step width (m) using motion capture system. Smaller values of step width indicate gait improvements
Measured: Baseline, change after 3 weeks, change after 3 months
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
Measured: Baseline, change after 3 weeks, change after 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2023
- Study start1 Nov 2022
- Primary completion1 Jun 2023
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinocerebellar AtaxiasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cagliari
- Sponsor type
- University, hospital or other
- Collaborators
- Angela Sanna, Micaela Porta, Paolo Tacconi, Chiara Pau
- Responsible party
- Principal investigator, Massimiliano Pau, University of Cagliari
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05951010
- Sponsor's protocol ID
- tDCS-ATX
- Status last verified
- Jul 2023
- First submitted
- 4 Jul 2023
- Last updated
- 18 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37540312
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05951010
- Acronym / sponsor ID
- tDCS-ATX
- Conditions
- Spinocerebellar Ataxias
- Keywords
- gait, ataxic symptoms, dysarthric symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University of CagliariUniversity, hospital or other
- Collaborators
- Angela Sanna, Micaela Porta, Paolo Tacconi, Chiara Pau
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 18 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transcranial direct current stimulation (tDCS) | Experimental | Device: Transcranial Direct Current StimulationParticipants 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age ≤ 80 and > 18 years
- diagnosis of SCA 38 with the presence of clinical symptoms.
Key exclusion criteria (4 listed)
- Inability to understand and sign the informed consent
- Presence of other severe neurological disorders
- presence of significant medical or psychiatric illnesses
- Pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial Direct Current StimulationAnodal 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. | Device | Transcranial direct current stimulation (tDCS) |
Primary outcome
Modified International Cooperative Ataxia Rating Scale (MICARS)
Time frame: 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
Robertson dysarthria profile
Time frame: 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
3 secondary outcomes
Gait Speed
Time frame: Baseline, change after 3 weeks, change after 3 months
Step width
Time frame: Baseline, change after 3 weeks, change after 3 months
Double support phase duration
Time frame: Baseline, change after 3 weeks, change after 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2023.
- Derived from this study: PubMed 37540312Sanna 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Direct Current Stimulation in people with Spinocerebellar Ataxias, run by University of Cagliari at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified International Cooperative Ataxia Rating Scale (MICARS) (time frame: Baseline, change after 3 weeks, change after 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05951010, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2023; AzTrials last refreshed its copy on 7 Nov 2026.