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

NCT01569958 | Unknown Phase 2 DMC

• 2 other identifiers: TDCS2011-01RF-ABR-2007-631680
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Amyotrophic Lateral Sclerosis

Outcome Measures

Primary Outcomes (1)

• Decline of ALSFRS-R (ALS functional rating scale-revised) from baseline to 12 months

  12 months

Secondary Outcomes (4)

• Decline of muscle strength from baseline to 12 months

  12 months

• Change of upper motor neuron signs from baseline to 12 months

  12 months

• Decline of forced vital capacity (percent of predicted normal) from baseline to 12 months

  12 months

• Change of quality of life from baseline to 12 months

  12 months

Study Arms (2)

tDCS

ACTIVE COMPARATOR

Other: transcranial direct current stimulation

sham

SHAM COMPARATOR

Other: Sham stimulation

Interventions

transcranial direct current stimulation OTHER

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

tDCS

Sham stimulation OTHER

1 mA stimulation for 30 seconds every 900 seconds per session

sham

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Università degli Studi 'G. d'Annunzio' Chieti e Pescara: lead
• Catholic University, Italy: collaborator
• Federico II University: collaborator
• Ministero della Salute, Italy: collaborator

Study Sites (3)

Centro Regionale Malattie Neuromuscolari, Ospedale Clinicizzato "SS. Annunziata"

Chieti, Chieti, 66013, Italy

RECRUITING

Azienda Policlinico Università Federico II

Napoli, Napoli, 80131, Italy

NOT YET RECRUITING

Policlinico Universitario Agostino Gemelli

Rome, Rome, 00168, Italy

NOT YET RECRUITING

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Alessandra Lugaresi, MD, PhD

  Università "G. d'Annunzio" di Chieti e Pescara, Dipartimento Neuroscienze ed Imaging, and ASL n. 2 Lanciano-Vasto-Chieti

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: March 9, 2012
• First Posted: April 3, 2012
• Study Start: July 1, 2012
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: October 10, 2012

Record last verified: 2012-10

Locations

IT (3)