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

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ClinicalTrials.gov Identifier: NCT00833820
Recruitment Status : Completed
First Posted : February 2, 2009
Last Update Posted : February 2, 2009
Sponsor:
Information provided by:
Catholic University of the Sacred Heart

Brief Summary:
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 or disease Intervention/treatment Phase
Amyotrophic Lateral Sclerosis Procedure: Real rTMS of the brain Procedure: Sham rTMS of the brain Phase 2 Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Repetitive Transcranial Magnetic Stimulation in Amyotrophic Lateral Sclerosis
Study Start Date : May 2007
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Rate of decline of ALSFRS-R score [ Time Frame: one year ]

Secondary Outcome Measures :
  1. Rate of decline of manual muscle force testing score [ Time Frame: one year ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: February 2, 2009    Key Record Dates
Last Update Posted: February 2, 2009
Last Verified: January 2009

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

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