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Repetitive Transcranial Magnetic Stimulation (rTMS) in Amyotrophic Lateral Sclerosis (rTMS-ALS)

This study has been completed.
Sponsor:
Information provided by:
Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier:
NCT00833820
First received: January 30, 2009
Last updated: NA
Last verified: January 2009
History: No changes posted
  Purpose

The investigators' preliminary studies demonstrated that repetitive transcranial magnetic stimulation (rTMS) of the brain may determine a slight slowing in the rate of disease progression in ALS patients (Di Lazzaro et al 2004, 2006). The aim of this study is to investigate whether rTMS of the motor cortex performed over a long period of time (12 months) in a group of patients with ALS, can have a more pronounced beneficial effect. The investigators will compare the disease progression in two groups of patients: the first group of patients will be treated with real rTMS (one week daily treatment every month) and the second group of patients will be treated with sham (placebo) rTMS.


Condition Intervention Phase
Amyotrophic Lateral Sclerosis
 Procedure: Real rTMS of the brain
Procedure: Sham rTMS of the brain
 Phase 2
Phase 3

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: Repetitive Transcranial Magnetic Stimulation in Amyotrophic Lateral Sclerosis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Catholic University of the Sacred Heart:

Primary Outcome Measures:
  • Rate of decline of ALSFRS-R score [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Rate of decline of manual muscle force testing score [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Enrollment: 20
Study Start Date: May 2007
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
Patients receiving real rTMS
 Procedure: Real rTMS of the brain
Repetitive transcranial magnetic stimulation will be performed using a focal coil held over motor cortex on each hemisphere. Stimulation protocol used will be the cTBS in which three pulses of stimulation are given at 50 Hz, repeated every 200 ms for a total of 300 pulses delivered over the right motor cortex. The stimulus intensity will be set at 80% of Action Motor Threshold.
Sham Comparator: B
patients receiving sham stimulation
 Procedure: Sham rTMS of the brain
Sham repetitive transcranial magnetic stimulation will be performed using the same stimulator connected to the placebo butterfly coil MCF-P-B-65 which has no stimulating effect on the cortex but produces similar auditory and tactile sensations as the active coil. The site of stimulation and the number of stimuli will be identical to those used for the active magnetic rTMS.

  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Eligible patients should have a diagnosis of definite ALS according to the El Escorial revised criteria with clear clinical upper and lower motor neuron signs.

Exclusion Criteria:

  • Contraindications to transcranial magnetic stimulation:

    • Tracheostomy
    • Pace-maker
    • Implanted metallic devices
    • Epilepsy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00833820

Locations
Italy
Institute of neurology Università Cattolica
Rome, Italy, 00168
Sponsors and Collaborators
Catholic University of the Sacred Heart
Investigators
Principal Investigator: Vincenzo Di Lazzaro, MD Institute of Neurology Università Cattolica Roma
  More Information

No publications provided by Catholic University of the Sacred Heart

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Vincenzo Di Lazzaro, Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier: NCT00833820     History of Changes
Other Study ID Numbers: 001
Study First Received: January 30, 2009
Last Updated: January 30, 2009
Health Authority: Italy: Ethics Committee

Keywords provided by Catholic University of the Sacred Heart:
ALS
transcranial brain stimulation

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 May 22, 2013