Clinical Trial: Rehabilitative Trial With Cerebello-Spinal tDCS in Neurodegenerative Ataxia

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Rehabilitative Trial With Cerebello-Spinal tDCS for the Treatment of Neurodegenerative Ataxia

Brief Summary: 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.

Detailed Summary:

Neurodegenerative cerebellar ataxias represent a heterogeneous group of disabling disorders in which progressive ataxia of gait, limb dysmetria, oculomotor deficits, dysarthria and kinetic tremor are the prominent clinical manifestations. Both the hereditary and sporadic forms usually present in young adulthood, and are characterized by atrophy of cerebellar or brainstem structures. Currently, cerebellar ataxia lack effective disease-modifying 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. The present randomized, double-blind, sham-controlled study will investigate 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.

Subjects will be randomized in two groups, one receiving a 10 day (5 days/week for 2 weeks) treatment with anodal cerebellar and cathodal spinal tDCS and the other receiving sham stimulation with identical parameters. After the intervention, patients will be reassessed with a clinical and neurophysiological evaluation at 2 weeks, 1 months and 3 month after treatment.

Sponsor: Azienda Ospedaliera Spedali Civili di Brescia

Current Primary Outcome:

• Change in the ICARS score from baseline [ Time Frame: Baseline - 2 weeks ]
  Change in the International Cooperative Ataxia Rating Scale (ICARS) score from baseline
• Change in the SARA score from baseline [ Time Frame: Baseline - 2 weeks ]
  Change in the Scale for the Assessment and Rating of Ataxia (SARA) score from baseline

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Change in the ICARS score from baseline [ Time Frame: Baseline - 1 month - 3 months ]
  Change in the International Cooperative Ataxia Rating Scale (ICARS) score from baseline
• Change in the SARA score from baseline [ Time Frame: Baseline - 1 month - 3 months ]
  Change in the Scale for the Assessment and Rating of Ataxia (SARA) score from baseline
• Change in the 9HPT score from baseline [ Time Frame: Baseline - 2 weeks - 1 month - 3 months ]
  Change in the Nine Hole Peg Test (9HPT) score (4 trials for each hand) from baseline
• Change in the 8MWT score from baseline [ Time Frame: Baseline - 2 weeks - 1 month - 3 months ]
  Change in the 8-Meter Walking Time score (4 trials) from baseline
• Change in CBI measurements from Baseline [ Time Frame: Baseline - 2 weeks - 1 month - 3 months ]
  By using transcranial magnetic stimulation (TMS), the investigators will evaluate the effects of tDCS on cerebellar brain inhibition (CBI)

Original Secondary Outcome: Same as current

Information By: Azienda Ospedaliera Spedali Civili di Brescia

Dates:
Date Received: April 14, 2017
Date Started: February 6, 2017
Date Completion: December 23, 2018
Last Updated: April 14, 2017
Last Verified: April 2017