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The aim of the study is to evaluate the effects on motor and cognitive performance of transcranial alternating current stimulation (tACS) compared to transcranial direct current stimulation (tDCS) and placebo stimulation (sham) in patients with neurodegenerative ataxia to identify a possible rehabilitation protocol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transcranial direct current stimulation (tDCS) | Active Comparator | Single session of anodal tDCS at 2 mA over the cerebellar hemispheres |
|
| Transcranial alternate current stimulation (tDCS) | Active Comparator | Single session of gamma tACS (50 Hz) at 3 mA over the cerebellar hemispheres |
|
| Placebo stimulation (sham) | Sham Comparator | Single session of sham tDCS over the cerebellar hemispheres |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcranial stimulation over the cerebellar hemispheres | Device | Single session of Transcranial stimulation over the cerebellar hemispheres |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in the International Cooperative Ataxia Rating Scale (ICARS) Score From Baseline | International Cooperative Ataxia Rating Scale (ICARS): semi-quantitative 100-point scale, yielding a total score of 0 (no ataxia) to 100 (most severe ataxia). | Baseline (immediately before the intervention) - Immediately after the intervention |
| Change in the Scale for the Assessment and Rating of Ataxia (SARA) Score From Baseline | Scale for the Assessment and Rating of Ataxia (SARA): 8-item performance based scale, yielding a total score of 0 (no ataxia) to 40 (most severe ataxia). | Baseline (immediately before the intervention) - Immediately after the intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Cerebellar Brain Inhibition (CBI) Measurements From Baseline | Cerebellar brain inhibition (CBI) is expressed as motor evoked potential amplitude (average of 10 recordings). Lower values reflect higher inhibition and thus reduced impairment. | Baseline (immediately before the intervention) - Immediately after the intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Barbara Borroni, MD | Asst Degli Spedali Civili Di Brescia | Principal Investigator |
| Alberto Benussi, MD | Università degli Studi di Brescia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ASST Spedali Civili di Brescia | Brescia | BS | 25123 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30135258 | Background | Benussi A, Dell'Era V, Cantoni V, Bonetta E, Grasso R, Manenti R, Cotelli M, Padovani A, Borroni B. Cerebello-spinal tDCS in ataxia: A randomized, double-blind, sham-controlled, crossover trial. Neurology. 2018 Sep 18;91(12):e1090-e1101. doi: 10.1212/WNL.0000000000006210. Epub 2018 Aug 22. | |
| 27838276 | Background |
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| Change in Timed Up and Go Test Duration From Baseline |
Time (in seconds) that a person takes to rise from a chair, walk three meters, turn around 180 degrees, walk back to the chair, and sit down while turning 180 degrees, assessed with gait sensors. |
| Baseline (immediately before the intervention) - Immediately after the intervention |
| Change in Walking Cadence From Baseline | Average Left and Right Steps/Minute during a 60 seconds walk, assessed with gait sensors. | Baseline (immediately before the intervention) - Immediately after the intervention |
| Change in 360° Turn From Baseline | Velocity (Number of Degrees/sec) in making a 360° turn, assessed with gait sensors | Baseline (immediately before the intervention) - Immediately after the intervention |
| Benussi A, Dell'Era V, Cotelli MS, Turla M, Casali C, Padovani A, Borroni B. Long term clinical and neurophysiological effects of cerebellar transcranial direct current stimulation in patients with neurodegenerative ataxia. Brain Stimul. 2017 Mar-Apr;10(2):242-250. doi: 10.1016/j.brs.2016.11.001. Epub 2016 Nov 3. |
| 26274840 | Background | Benussi A, Koch G, Cotelli M, Padovani A, Borroni B. Cerebellar transcranial direct current stimulation in patients with ataxia: A double-blind, randomized, sham-controlled study. Mov Disord. 2015 Oct;30(12):1701-5. doi: 10.1002/mds.26356. Epub 2015 Aug 14. |
| 33950222 | Background | Benussi A, Cantoni V, Manes M, Libri I, Dell'Era V, Datta A, Thomas C, Ferrari C, Di Fonzo A, Fancellu R, Grassi M, Brusco A, Alberici A, Borroni B. Motor and cognitive outcomes of cerebello-spinal stimulation in neurodegenerative ataxia. Brain. 2021 Sep 4;144(8):2310-2321. doi: 10.1093/brain/awab157. |
| 37349632 | Derived | Libri I, Cantoni V, Benussi A, Rivolta J, Ferrari C, Fancellu R, Synofzik M, Alberici A, Padovani A, Borroni B. Comparing Cerebellar tDCS and Cerebellar tACS in Neurodegenerative Ataxias Using Wearable Sensors: A Randomized, Double-Blind, Sham-Controlled, Triple-Crossover Trial. Cerebellum. 2024 Apr;23(2):570-578. doi: 10.1007/s12311-023-01578-6. Epub 2023 Jun 22. |
| ID | Term |
|---|---|
| D001259 | Ataxia |
| D020754 | Spinocerebellar Ataxias |
| D019578 | Multiple System Atrophy |
| C537308 | Spinocerebellar ataxia, autosomal recessive 1 |
| D002524 | Cerebellar Ataxia |
| ID | Term |
|---|---|
| D020820 | Dyskinesias |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002526 | Cerebellar Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D013132 | Spinocerebellar Degenerations |
| D013118 | Spinal Cord Diseases |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D054969 | Primary Dysautonomias |
| D001342 | Autonomic Nervous System Diseases |
| D001480 | Basal Ganglia Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
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