The Influence of Deep TMS on Cerebellar Signs in Patients With Machado Joseph Disease

NCT02039206 | Completed Phase 2 DMC

• 2 other identifiers: MJD MEIR dTMS0059-13-MMC
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

To test the effects of low frequency deep rTMS using the novel HCERMJD-coil on cerebellar deficits in patients with SCA3 and to establish its safety in this population. Investigator is anticipate that stimulation of the cerebellum with the novel HCERMJD-coil may induce significantly therapeutic effects in patients with SCA3 and will pave the way for establishing a novel and effective treatment for this disorder.

Conditions

Machado Joseph Disease (SCA3)

Keywords

Machado Joseph disease; Deep TMS; TMS; Transcranial Magnetic Stimulation; SCA3; Magnetic Stimulation; Brainsway

Outcome Measures

Primary Outcomes (1)

• Scale for the Assessment and Rating of Ataxia (SARA)

  30 days

Study Arms (1)

Treatment

EXPERIMENTAL

Deep TMS

Device: Deep TMS

Interventions

Deep TMS DEVICE

1Hz Stimulation

Treatment

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• SCA3 patients aged 20 - 80 years, with detectable clinical signs and confirmed genetic diagnosis.

You may not qualify if:

• Patients who have concomitant epilepsy.
• History of seizure or heat convulsion.
• Patients on neuroleptics.
• Patients with dementia (MMSE\<25) or any unstable medical disorder.
• History or current unstable hypertension.
• History of head injury or neurosurgical interventions.
• History of any metal in the head (outside the mouth).
• Known history of any metallic particles in the eye, implanted cardiac pacemaker, implanted neurostimulators, surgical clips (above the shoulder line) or any medical pumps.
• History of frequent or severe headaches.
• History of migraine.
• History of hearing loss.
• History of cochlear implants
• History of drug abuse or alcoholism.
• Pregnancy or not using a reliable method of birth control.
• Participation in current clinical study or clinical study within 30 days prior to this study.

Sponsors & Collaborators

• Brainsway: lead

Study Sites (1)

Meir Medical Center

Kfar Saba, Israel

Location

MeSH Terms

Conditions

Machado-Joseph Disease

Condition Hierarchy (Ancestors)

Spinocerebellar Ataxias; Cerebellar Ataxia; Cerebellar Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Spinocerebellar Degenerations; Spinal Cord Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Ataxia; Dyskinesias; Neurologic Manifestations; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Carlos Gordon, Prof.

  Meir Health Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2013
• First Posted: January 17, 2014
• Study Start: February 1, 2014
• Primary Completion: February 1, 2015
• Study Completion: June 1, 2016
• Last Updated: January 25, 2018

Record last verified: 2018-01

Locations

IL (1)