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

NCT ID: NCT01569958

Last Updated: 2012-10-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2016-04-30

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.

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.

Conditions

Amyotrophic Lateral Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

tDCS

Group Type: ACTIVE_COMPARATOR

transcranial direct current stimulation

Intervention Type: 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

sham

Group Type: SHAM_COMPARATOR

Sham stimulation

Intervention Type: OTHER

1 mA stimulation for 30 seconds every 900 seconds per session

Interventions

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

Intervention Type: OTHER

Sham stimulation

1 mA stimulation for 30 seconds every 900 seconds per session

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Catholic University, Italy

OTHER

Sponsor Role: collaborator

Federico II University

OTHER

Sponsor Role: collaborator

Ministero della Salute, Italy

OTHER

Sponsor Role: collaborator

Università degli Studi 'G. d'Annunzio' Chieti e Pescara

OTHER

Sponsor Role: lead

Responsible Party

Alessandra Lugaresi

Prof

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alessandra Lugaresi, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Chieti, Chieti, Italy

Site Status: RECRUITING

Azienda Policlinico Università Federico II

Napoli, Napoli, Italy

Site Status: NOT_YET_RECRUITING

Policlinico Universitario Agostino Gemelli

Rome, Rome, Italy

Site Status: NOT_YET_RECRUITING

Countries

Italy

Facility Contacts

Margherita Capasso, MD, PhD

Role: primary

Other Identifiers

RF-ABR-2007-631680

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

TDCS2011-01

Identifier Type: -

Identifier Source: org_study_id