Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Rehabilitative Trial With Cerebello-Spinal tDCS in Neurodegenerative Ataxia (CStDCSAtaxia)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03120013
Recruitment Status : Active, not recruiting
First Posted : April 19, 2017
Last Update Posted : September 6, 2017
Sponsor:
Information provided by (Responsible Party):
Barbara Borroni, Azienda Ospedaliera Spedali Civili di Brescia

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.

Condition or disease Intervention/treatment Phase
Ataxia, Cerebellar Cerebellar Ataxia Spinocerebellar Ataxias Ataxia, Spinocerebellar Spinocerebellar Ataxia Type 1 Spinocerebellar Ataxia Type 2 Spinocerebellar Ataxia 3 Spinocerebellar Degenerations Friedreich Ataxia Ataxia With Oculomotor Apraxia Multiple System Atrophy Device: Anodal cerebellar and cathodal spinal tDCS Device: Sham cerebellar and sham spinal tDCS Not Applicable

Detailed Description:

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Rehabilitative Trial With Cerebello-Spinal tDCS for the Treatment of Neurodegenerative Ataxia
Actual Study Start Date : February 6, 2017
Estimated Primary Completion Date : December 1, 2018
Estimated Study Completion Date : December 23, 2018


Arm Intervention/treatment
Experimental: Real tDCS
10 days anodal cerebellar and cathodal spinal tDCS
Device: Anodal cerebellar and cathodal spinal tDCS
10 sessions of anodal cerebellar and cathodal spinal transcranial direct current stimulation (5 days/week for 2 weeks)

Sham Comparator: Sham tDCS
10 days sham cerebellar and sham spinal tDCS
Device: Sham cerebellar and sham spinal tDCS
10 sessions of sham cerebellar and sham spinal transcranial direct current stimulation (5 days/week for 2 weeks)




Primary Outcome Measures :
  1. Change in the ICARS score from baseline [ Time Frame: Baseline - 2 weeks ]
    Change in the International Cooperative Ataxia Rating Scale (ICARS) score from baseline

  2. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03120013


Locations
Layout table for location information
Italy
AO Spedali Civili
Brescia, BS, Italy, 25100
Sponsors and Collaborators
Azienda Ospedaliera Spedali Civili di Brescia
Investigators
Layout table for investigator information
Principal Investigator: Barbara Borroni, MD Azienda Ospedaliera Spedali Civili, Brescia

Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Barbara Borroni, Professor, Azienda Ospedaliera Spedali Civili di Brescia
ClinicalTrials.gov Identifier: NCT03120013     History of Changes
Other Study ID Numbers: NP1576
First Posted: April 19, 2017    Key Record Dates
Last Update Posted: September 6, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Barbara Borroni, Azienda Ospedaliera Spedali Civili di Brescia:
Transcranial direct current stimulation
Transcranial magnetic stimulation
Spinocerebellar ataxia
Cerebellar ataxia

Additional relevant MeSH terms:
Layout table for MeSH terms
Atrophy
Ataxia
Cerebellar Ataxia
Spinocerebellar Ataxias
Spinocerebellar Degenerations
Multiple System Atrophy
Shy-Drager Syndrome
Friedreich Ataxia
Apraxias
Cogan Syndrome
Machado-Joseph Disease
Pathological Conditions, Anatomical
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Cerebellar Diseases
Brain Diseases
Central Nervous System Diseases
Spinal Cord Diseases
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Primary Dysautonomias
Autonomic Nervous System Diseases
Basal Ganglia Diseases
Movement Disorders
Hypotension
Vascular Diseases
Cardiovascular Diseases