Multiple System Atrophy Clinical Trial
— CStDCSAtaxiaOfficial title:
Rehabilitative Trial With Cerebello-Spinal tDCS for the Treatment of Neurodegenerative Ataxia
Verified date | March 2020 |
Source | Azienda Ospedaliera Spedali Civili di Brescia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Neurodegenerative cerebellar ataxias represent a group of disabling disorders for which we currently lack effective therapies. Cerebellar transcranial direct current stimulation (tDCS) is a non-invasive technique, which has been demonstrated to modulate cerebellar excitability and improve symptoms in patients with cerebellar ataxias. In this randomized, double-blind, sham-controlled study, the investigators will evaluate whether a two-weeks' treatment with cerebellar anodal tDCS and spinal cathodal tDCS can improve symptoms in patients with neurodegenerative cerebellar ataxia and can modulate cerebello-motor connectivity, at short and long term.
Status | Completed |
Enrollment | 21 |
Est. completion date | December 1, 2018 |
Est. primary completion date | December 1, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients with a cerebellar syndrome and quantifiable cerebellar atrophy Exclusion Criteria: - Severe head trauma in the past - History of seizures - History of ischemic stroke or hemorrhage - Pacemaker - Metal implants in the head/neck region - Severe comorbidity - Intake of illegal drugs - Pregnancy |
Country | Name | City | State |
---|---|---|---|
Italy | AO Spedali Civili | Brescia | BS |
Lead Sponsor | Collaborator |
---|---|
Azienda Ospedaliera Spedali Civili di Brescia |
Italy,
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. — View Citation
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. — View Citation
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. — View Citation
Bikson M, Grossman P, Thomas C, Zannou AL, Jiang J, Adnan T, Mourdoukoutas AP, Kronberg G, Truong D, Boggio P, Brunoni AR, Charvet L, Fregni F, Fritsch B, Gillick B, Hamilton RH, Hampstead BM, Jankord R, Kirton A, Knotkova H, Liebetanz D, Liu A, Loo C, Nitsche MA, Reis J, Richardson JD, Rotenberg A, Turkeltaub PE, Woods AJ. Safety of Transcranial Direct Current Stimulation: Evidence Based Update 2016. Brain Stimul. 2016 Sep-Oct;9(5):641-661. doi: 10.1016/j.brs.2016.06.004. Epub 2016 Jun 15. Review. — View Citation
Fiocchi S, Ravazzani P, Priori A, Parazzini M. Cerebellar and Spinal Direct Current Stimulation in Children: Computational Modeling of the Induced Electric Field. Front Hum Neurosci. 2016 Oct 17;10:522. eCollection 2016. — View Citation
Lefaucheur JP, Antal A, Ayache SS, Benninger DH, Brunelin J, Cogiamanian F, Cotelli M, De Ridder D, Ferrucci R, Langguth B, Marangolo P, Mylius V, Nitsche MA, Padberg F, Palm U, Poulet E, Priori A, Rossi S, Schecklmann M, Vanneste S, Ziemann U, Garcia-Larrea L, Paulus W. Evidence-based guidelines on the therapeutic use of transcranial direct current stimulation (tDCS). Clin Neurophysiol. 2017 Jan;128(1):56-92. doi: 10.1016/j.clinph.2016.10.087. Epub 2016 Oct 29. Review. — View Citation
Miranda PC, Salvador R, Wenger C, Fernandes SR. Computational models of non-invasive brain and spinal cord stimulation. Conf Proc IEEE Eng Med Biol Soc. 2016 Aug;2016:6457-6460. doi: 10.1109/EMBC.2016.7592207. — View Citation
Rossini PM, Burke D, Chen R, Cohen LG, Daskalakis Z, Di Iorio R, Di Lazzaro V, Ferreri F, Fitzgerald PB, George MS, Hallett M, Lefaucheur JP, Langguth B, Matsumoto H, Miniussi C, Nitsche MA, Pascual-Leone A, Paulus W, Rossi S, Rothwell JC, Siebner HR, Ugawa Y, Walsh V, Ziemann U. Non-invasive electrical and magnetic stimulation of the brain, spinal cord, roots and peripheral nerves: Basic principles and procedures for routine clinical and research application. An updated report from an I.F.C.N. Committee. Clin Neurophysiol. 2015 Jun;126(6):1071-1107. doi: 10.1016/j.clinph.2015.02.001. Epub 2015 Feb 10. Review. — View Citation
van Dun K, Bodranghien F, Manto M, Mariën P. Targeting the Cerebellum by Noninvasive Neurostimulation: a Review. Cerebellum. 2017 Jun;16(3):695-741. doi: 10.1007/s12311-016-0840-7. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 - 2 weeks | |
Primary | 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 - 2 weeks | |
Secondary | 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 - 2 weeks - 1 month - 3 months | |
Secondary | 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 - 2 weeks - 1 month - 3 months | |
Secondary | Change in the 9 Hole Peg Test (9HPT) Score From Baseline | 4 timed trials of the 9 hole peg test (9HPT) were performed and averaged (mean values are reported) for each separate hand (dominant and nondominant). The total time to complete the task is recorded for each trial and for each separate hand (dominant and nondominant). Longer times represent greater impairment. | Baseline - 2 weeks - 1 month - 3 months | |
Secondary | Change in the 8-Meter Walking Time (8MW) Score From Baseline | 4 timed trials of the 8 meter walking time (8MW) were performed and averaged (mean values are reported). Longer times represent greater impairment. | Baseline - 2 weeks - 1 month - 3 months | |
Secondary | 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 - 2 weeks - 1 month - 3 months | |
Secondary | Change in the Short-Form Health Survey 36 (SF36) Score From Baseline | The Italian version of the Short-Form Health Survey 36 (SF-36): consists of 36 scaled score, yielding a total score of 0 (more disability) to 100 (less disability). | Baseline - 2 weeks - 1 month - 3 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03593512 -
Deep Brain Stimulation for Autonomic and Gait Symptoms in Multiple System Atrophy
|
N/A | |
Recruiting |
NCT03648905 -
Clinical Laboratory Evaluation of Chronic Autonomic Failure
|
||
Active, not recruiting |
NCT05699460 -
Pre-Gene Therapy Study in Parkinson's Disease and Multiple System Atrophy
|
||
Recruiting |
NCT02897063 -
Effects of Midodrine and Droxidopa on Splanchnic Capacitance in Autonomic Failure
|
Phase 1 | |
Not yet recruiting |
NCT00758849 -
Fipamezole in Neurogenic Orthostatic Hypotension
|
Phase 2 | |
Completed |
NCT01155492 -
Increased Gut Permeability to Lipopolysaccharides (LPS) in Parkinson's Disease
|
N/A | |
Recruiting |
NCT04431713 -
Exenatide Once-weekly as a Treatment for Multiple System Atrophy
|
Phase 2 | |
Completed |
NCT04184063 -
Study of NBMI Treatment in Patients With Atypical Parkinsons (PSP or MSA)
|
Phase 2 | |
Recruiting |
NCT05121012 -
Synaptic Loss in Multiple System Atrophy
|
||
Terminated |
NCT03589976 -
A Futility Trial of Sirolimus in Multiple System Atrophy
|
Phase 2 | |
Recruiting |
NCT04706234 -
Systematic Assessment of Laryngopharyngeal Function in Patients With MSA, PD, and 4repeat Tauopathies
|
||
Completed |
NCT00368199 -
Transcranial Duplex Scanning and Single Photon Emission Computer Tomography (SPECT) in Parkinsonian Syndromes
|
N/A | |
Recruiting |
NCT04472130 -
Neurodegenerative Diseases Registry
|
||
Recruiting |
NCT04876326 -
Potential Use of Autologous and Allogeneic Mesenchymal Stem Cells in Patients With Multiple System Atrophy
|
N/A | |
Recruiting |
NCT04680065 -
GDNF Gene Therapy for Multiple System Atrophy
|
Phase 1 | |
Completed |
NCT03753763 -
Safinamide for Multiple System Atrophy (MSA)
|
Phase 2 | |
Recruiting |
NCT04250493 -
Insulin Resistance in Multiple System Atrophy
|
N/A | |
Recruiting |
NCT06072105 -
Medical Decision Making in Multiple System Atrophy
|
N/A | |
Terminated |
NCT02149901 -
Water and Sudafed in Autonomic Failure
|
Early Phase 1 | |
Terminated |
NCT00997672 -
Lithium in Multiple System Atrophy
|
Phase 2 |