Transcranial Direct Current Stimulation as a Novel Therapeutic Approach in Amyotrophic Lateral Sclerosis

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by Università degli Studi 'G. d'Annunzio' Chieti e Pescara
Sponsor:
Collaborators:
Catholic University, Italy
Federico II University
Ministero della Salute, Italy
Information provided by (Responsible Party):
Alessandra Lugaresi, Università degli Studi 'G. d'Annunzio' Chieti e Pescara
ClinicalTrials.gov Identifier:
NCT01569958
First received: March 9, 2012
Last updated: October 8, 2012
Last verified: October 2012
  Purpose

Amyotrophic Lateral Sclerosis (ALS) is a neurodegenerative disease characterized by progressive weakness and muscular atrophy due to the degeneration and loss of motor neurons, the nerve cells that, in the central nervous system (motor cortex, brainstem and spinal chord), control voluntary movement. Riluzole, the only drug approved for ALS treatment, modestly slow disease progression.

Transcranial direct current stimulation (tDCS) is a noninvasive technique of neuromodulation that is currently studied as a possible therapeutic tool for several neurological and psychiatric diseases and has been found safe and well tolerated. Based on experimental evidence in animals and human subjects, tDCS is expected to reduce motor cortex excitability and excitotoxicity, that is neuronal injury induced by excessive glutamatergic stimulation, one of postulated pathophysiological mechanisms in ALS.

This study will investigate if transcranial direct current stimulation of motor cortex is useful in delaying disease progression and is well tolerated in ALS patients.


Condition Intervention Phase
Amyotrophic Lateral Sclerosis
Other: transcranial direct current stimulation
Other: Sham stimulation
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Transcranial Direct Current Stimulation as a Novel Therapeutic Approach in Amyotrophic Lateral Sclerosis

Resource links provided by NLM:


Further study details as provided by Università degli Studi 'G. d'Annunzio' Chieti e Pescara:

Primary Outcome Measures:
  • Decline of ALSFRS-R (ALS functional rating scale-revised) from baseline to 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Decline of muscle strength from baseline to 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    A megascore will be obtained by summing scores of single muscles manually tested according to the Medical Research Council Scale

  • Change of upper motor neuron signs from baseline to 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    A score will be obtained based on presence/absence of listed upper motor neuron signs and grade of spasticity

  • Decline of forced vital capacity (percent of predicted normal) from baseline to 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Change of quality of life from baseline to 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    The ALSAQ-40 questionnaire will be employed


Estimated Enrollment: 54
Study Start Date: July 2012
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: tDCS Other: transcranial direct current stimulation
transcranial direct current stimulation applied to the motor cortex of both sides (1 mA, 20 minutes) for five consecutive days every month for 12 months
Sham Comparator: sham Other: Sham stimulation
1 mA stimulation for 30 seconds every 900 seconds per session

Detailed Description:

This is a double blind, randomized, placebo-controlled clinical trial.

Cathodic tDCS (1 mA for 20 minutes) will be sequentially applied over the motor cortex of both sides, for five consecutive days every month for twelve months. The control group will receive a sham stimulation that reproduce tactile sensation of real stimulation but has no effects on central nervous system. For stimulation, researchers will employ a CE-certified medical device acting as a micro-processor-controlled constant current source. All patients will take riluzole during the entire period of the study.

Fifty-four participants will be recruited from three Italian Centers and randomized to one of two arms of the study.

Disease progression and quality of life will be evaluated at baseline and every three months during the study.

At each visit adverse events will be reported and tolerability will be assessed through a specific questionnaire.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • diagnosis of probable, laboratory-supported probable, or definite amyotrophic lateral sclerosis according to the El Escorial revised criteria
  • spinal onset
  • aged 18 to 85 years inclusive
  • disease duration ≤ 24 months
  • disease progression in the past 3 months
  • FVC ≥ 70% of predicted
  • 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
  • in 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:

  • bulbar onset
  • previous poliomyelitis
  • motor neuron diseases other than ALS
  • clinical involvement of other neurological systems
  • pregnancy, lactation,or unwillingness to contraception if required
  • possible contraindications to tDCS: metals in the head (excluding the mouth); electromedical devices; seizures; drugs or neurological conditions lowering seizure threshold; alcoholism; severe heart diseases
  • any severe disease other than ALS
  • experimental drugs within 1 month prior to enrollment
  • drugs potentially modifying the response to tDCS
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01569958

Locations
Italy
Centro Regionale Malattie Neuromuscolari, Ospedale Clinicizzato "SS. Annunziata" Recruiting
Chieti, Italy, 66013
Contact: Margherita Capasso, MD, PhD    00390871358585    neurolab@unich.it   
Principal Investigator: Alessandra Lugaresi, MD, PhD         
Sub-Investigator: Margherita Capasso, MD,PhD         
Azienda Policlinico Università Federico II Not yet recruiting
Napoli, Italy, 80131
Principal Investigator: Lucio Santoro, MD         
Policlinico Universitario Agostino Gemelli Not yet recruiting
Rome, Italy, 00168
Principal Investigator: Vincenzo Di Lazzaro, MD         
Sponsors and Collaborators
Università degli Studi 'G. d'Annunzio' Chieti e Pescara
Catholic University, Italy
Federico II University
Ministero della Salute, Italy
Investigators
Principal Investigator: Alessandra Lugaresi, MD, PhD Università "G. d'Annunzio" di Chieti e Pescara, Dipartimento Neuroscienze ed Imaging, and ASL n. 2 Lanciano-Vasto-Chieti
  More Information

No publications provided

Responsible Party: Alessandra Lugaresi, Prof, Università degli Studi 'G. d'Annunzio' Chieti e Pescara
ClinicalTrials.gov Identifier: NCT01569958     History of Changes
Other Study ID Numbers: TDCS2011-01, RF-ABR-2007-631680
Study First Received: March 9, 2012
Last Updated: October 8, 2012
Health Authority: Italy: Ethics Committee

Additional relevant MeSH terms:
Amyotrophic Lateral Sclerosis
Sclerosis
Motor Neuron Disease
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
TDP-43 Proteinopathies
Neuromuscular Diseases
Proteostasis Deficiencies
Metabolic Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 28, 2014