Transcranial Direct Current Stimulation as a Novel Therapeutic Approach in Amyotrophic Lateral Sclerosis
Recruitment status was: Recruiting
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.
|Amyotrophic Lateral Sclerosis||Other: transcranial direct current stimulation Other: Sham stimulation||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Transcranial Direct Current Stimulation as a Novel Therapeutic Approach in Amyotrophic Lateral Sclerosis|
- Decline of ALSFRS-R (ALS functional rating scale-revised) from baseline to 12 months [ Time Frame: 12 months ]
- Decline of muscle strength from baseline to 12 months [ Time Frame: 12 months ]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 ]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 ]
- Change of quality of life from baseline to 12 months [ Time Frame: 12 months ]The ALSAQ-40 questionnaire will be employed
|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)|
|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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01569958
|Centro Regionale Malattie Neuromuscolari, Ospedale Clinicizzato "SS. Annunziata"||Recruiting|
|Chieti, Italy, 66013|
|Contact: Margherita Capasso, MD, PhD 00390871358585 email@example.com|
|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|
|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|