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

This study is currently recruiting participants. (see Contacts and Locations)

Verified September 2014 by Brainsway

Sponsor:

Information provided by (Responsible Party):

Brainsway

ClinicalTrials.gov Identifier:

NCT02039206

First received: December 29, 2013

Last updated: September 15, 2014

Last verified: September 2014

History of Changes

Purpose

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.

Condition	Intervention	Phase
Machado Joseph Disease (SCA3)	Device: Deep TMS	Phase 2


Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	The Influence of Deep Repetitive Transcranial Magnetic Stimulation (TMS) on Cerebellar Signs in Patients With Spinocerebellar Ataxia Type 3 (SCA3 - Machado Joseph Disease)

Resource links provided by NLM:

Genetics Home Reference related topics: autosomal recessive cerebellar ataxia type 1 infantile-onset spinocerebellar ataxia Saethre-Chotzen syndrome spinocerebellar ataxia type 1 spinocerebellar ataxia type 2 spinocerebellar ataxia type 3 spinocerebellar ataxia type 6 VLDLR-associated cerebellar hypoplasia

Genetic and Rare Diseases Information Center resources: Saethre-Chotzen Syndrome Spinocerebellar Ataxia Spinocerebellar Ataxia 3

U.S. FDA Resources

Further study details as provided by Brainsway:

Primary Outcome Measures:

Scale for the Assessment and Rating of Ataxia (SARA) [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]


Estimated Enrollment:	20
Study Start Date:	February 2014
Estimated Study Completion Date:	February 2015
Estimated Primary Completion Date:	February 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Treatment Deep TMS	Device: Deep TMS 1Hz Stimulation

Eligibility


Ages Eligible for Study:	20 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02039206

Locations


Israel
Meir Medical Center	Recruiting
Kfar Saba, Israel
Contact: Carlos Gordon, Prof. 00-972-9-7471581 Carlos.Gordon@clalit.org.il
Principal Investigator: Carlos Gordon, Prof.

Sponsors and Collaborators

Brainsway

Investigators


Principal Investigator:	Carlos Gordon, Prof.	Meir Health Center

More Information

No publications provided


Responsible Party:	Brainsway
ClinicalTrials.gov Identifier:	NCT02039206 History of Changes
Other Study ID Numbers:	MJD MEIR dTMS, 0059-13-MMC
Study First Received:	December 29, 2013
Last Updated:	September 15, 2014
Health Authority:	Israel: Ministry of Health

Keywords provided by Brainsway:


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

Additional relevant MeSH terms:


Cerebellar Ataxia Machado-Joseph Disease Ataxia Brain Diseases Central Nervous System Diseases Cerebellar Diseases Dyskinesias Genetic Diseases, Inborn	Heredodegenerative Disorders, Nervous System Nervous System Diseases Neurodegenerative Diseases Neurologic Manifestations Spinal Cord Diseases Spinocerebellar Ataxias Spinocerebellar Degenerations

ClinicalTrials.gov processed this record on March 03, 2015

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