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Rehabilitative Trial With tDCS in Amyotrophic Lateral Sclerosis (tDCS_MND)

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ClinicalTrials.gov Identifier: NCT03293394
Recruitment Status : Completed
First Posted : September 26, 2017
Last Update Posted : May 22, 2019
Sponsor:
Information provided by (Responsible Party):
Barbara Borroni, Azienda Ospedaliera Spedali Civili di Brescia

Brief Summary:

Amyotrophic Lateral Sclerosis (ALS) is a motor neuron disease, which is a group of neurological disorders that selectively affect motor neurons, the cells that control voluntary muscles of the body. The disorder causes muscle weakness and atrophy throughout the body due to the degeneration of the upper and lower motor neurons. Current drugs approved for ALS treatment only modestly slow disease progression.

Transcranial direct current stimulation (tDCS) is a non-invasive technique, which has been demonstrated to modulate cerebral excitability in several neurodegenerative disorders and modulate intracortical connectivity measures.

In this randomized, double-blind, sham-controlled study, the investigators will evaluate whether a two-weeks' treatment with bilateral motor cortex anodal tDCS and spinal cathodal tDCS can improve symptoms in patients with amyotrophic lateral sclerosis and modulate intracortical connectivity, at short and long term.


Condition or disease Intervention/treatment Phase
Amyotrophic Lateral Sclerosis Device: Anodal bilateral motor cortex and cathodal spinal tDCS Device: Sham bilateral motor cortex and sham spinal tDCS Not Applicable

Detailed Description:

Amyotrophic Lateral Sclerosis (ALS) is a motor neuron disease, which is a group of neurological disorders that selectively affect motor neurons, the cells that control voluntary muscles of the body. The disorder causes muscle weakness and atrophy throughout the body due to the degeneration of the upper and lower motor neurons. Current drugs approved for ALS treatment only modestly slow disease progression.

Transcranial direct current stimulation (tDCS) is a non-invasive technique, which has been demonstrated to modulate cerebral excitability in several neurodegenerative disorders and modulate intracortical connectivity measures.

In this randomized, double-blind, sham-controlled study, the investigators will evaluate whether a two-weeks' treatment with bilateral motor cortex anodal tDCS and spinal cathodal tDCS can improve symptoms in patients with amyotrophic lateral sclerosis and modulate intracortical 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 bilateral motor cortex tDCS 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, 2 months and 6 months after treatment. Furthermore, blood neurofilaments will be measured at each time point.

Clinical evaluation will include the ALSFRS-R, ALSAQ-40, CBI, EQ-5D-5L, muscle strength evaluated with the MRC scale.

Neurophysiological evaluation will include measures of intracortical connectivity, evaluated with transcranial magnetic stimulation (TMS) as short interval intracortical inhibition (SICI-ICF), long interval intracortical inhibition (LICI), short interval intracortical facilitation (SICF).


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Rehabilitative Trial With Transcranial Direct Current Stimulation (tDCS) in Amyotrophic Lateral Sclerosis
Actual Study Start Date : October 2, 2017
Actual Primary Completion Date : June 20, 2018
Actual Study Completion Date : July 1, 2018


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

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




Primary Outcome Measures :
  1. Change in muscle strength from baseline [ Time Frame: Baseline - 2 weeks - 2 months - 6 months ]
    A megascore will be obtained by summing scores of single muscles manually evaluated according to the Medical Research Council (MRC) Scale


Secondary Outcome Measures :
  1. Change in short-interval intracortical inhibition-facilitation (SICI-ICF) from baseline [ Time Frame: Baseline - 2 weeks - 2 months - 6 months ]
    By using transcranial magnetic stimulation (TMS), the investigators will evaluate the effects of tDCS on short-interval intracortical inhibition-facilitation (SICI-ICF) from baseline

  2. Decline in the ALSFRS-R score from baseline [ Time Frame: Baseline - 2 weeks - 2 months - 6 months ]
    Decline in the ALS Functional Rating Scale (ALSFRS-R) score from baseline

  3. Change of quality of life from baseline: ALSAQ-40 scale [ Time Frame: Baseline - 2 weeks - 2 months - 6 months ]
    Change of quality of life from baseline evaluated with the ALSAQ-40 scale

  4. Change of quality of life from baseline: EQ-5D-5L scale [ Time Frame: Baseline - 2 weeks - 2 months - 6 months ]
    Change of quality of life from baseline evaluated with the EQ-5D-5L scale

  5. Change of quality of life from baseline: EQ-VAS scale [ Time Frame: Baseline - 2 weeks - 2 months - 6 months ]
    Change of quality of life from baseline evaluated with the EQ-VAS scale

  6. Change in caregiver burden [ Time Frame: Baseline - 2 weeks - 2 months - 6 months ]
    Change of quality of life from baseline evaluated with the CBI scale



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with a diagnosis of probable, laboratory-supported probable, or definite amyotrophic lateral sclerosis according to the El Escorial revised criteria
  • Disease duration ≤ 24 months
  • Disease progression in the past 3 months
  • Score ≥ 2 at the item "swallowing" of the ALS Functional Rating Scale Revised
  • Score ≥ 2 at the item "walking" of the ALS Functional Rating Scale Revised
  • Treatment with steady regimen of riluzole for a minimum of 1 month before study entry, and desiring its continuation
  • Able to give informed consent
  • Written informed consent

Exclusion Criteria:

  • Motor neuron diseases other than ALS
  • 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): NCT03293394


Locations
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Italy
AO Spedali Civili
Brescia, BS, Italy, 25100
Sponsors and Collaborators
Azienda Ospedaliera Spedali Civili di Brescia
Investigators
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Principal Investigator: Barbara Borroni, MD Azienda Ospedaliera Spedali Civili, Brescia

Publications:
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Responsible Party: Barbara Borroni, Professor, Azienda Ospedaliera Spedali Civili di Brescia
ClinicalTrials.gov Identifier: NCT03293394     History of Changes
Other Study ID Numbers: NP2743
First Posted: September 26, 2017    Key Record Dates
Last Update Posted: May 22, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Barbara Borroni, Azienda Ospedaliera Spedali Civili di Brescia:
Amyotrophic Lateral Sclerosis
Motor Neuron Disease
Transcranial Direct Current Stimulation
Additional relevant MeSH terms:
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Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Sclerosis
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases