Repetitive Transcranial Magnetic Stimulation (rTMS) in Amyotrophic Lateral Sclerosis

NCT00833820 | Completed Phase 2

• 1 other identifier: 001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Amyotrophic Lateral Sclerosis

Keywords

ALS; transcranial brain stimulation

Outcome Measures

Primary Outcomes (1)

• Rate of decline of ALSFRS-R score

  one year

Secondary Outcomes (1)

• Rate of decline of manual muscle force testing score

  one year

Study Arms (2)

A

ACTIVE COMPARATOR

Patients receiving real rTMS

Procedure: Real rTMS of the brain

B

SHAM COMPARATOR

patients receiving sham stimulation

Procedure: Sham rTMS of the brain

Interventions

Real rTMS of the brain PROCEDURE

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.

A

Sham rTMS of the brain PROCEDURE

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.

B

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Contraindications to transcranial magnetic stimulation:
• Tracheostomy
• Pace-maker
• Implanted metallic devices
• Epilepsy

Sponsors & Collaborators

• Catholic University of the Sacred Heart: lead

Study Sites (1)

Institute of neurology Università Cattolica

Rome, 00168, Italy

Location

Related Publications (1)

• Di Lazzaro V, Pilato F, Profice P, Ranieri F, Musumeci G, Florio L, Beghi E, Frisullo G, Capone F, Sabatelli M, Tonali PA, Dileone M. Motor cortex stimulation for ALS: a double blind placebo-controlled study. Neurosci Lett. 2009 Oct 16;464(1):18-21. doi: 10.1016/j.neulet.2009.08.020. Epub 2009 Aug 12.

  PMID: 19682544 DERIVED

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

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

Study Officials

• Vincenzo Di Lazzaro, MD

  Institute of Neurology Università Cattolica Roma

  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

Study Record Dates

• First Submitted: January 30, 2009
• First Posted: February 2, 2009
• Study Start: May 1, 2007
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: February 2, 2009

Record last verified: 2009-01

Locations

IT (1)