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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT02221544 |
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Date of registration:
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19/08/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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The Effect of Low-frequency rTMS on Motor Function in PD Patients With Freezing of Gait
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Scientific title:
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The Effect of Low-frequency Repetitive Transcranial Magnetic Stimulation on Motor Function in Patients With Parkinson's Disease (PD) With Freezing of Gait (FOG). |
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Date of first enrolment:
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September 2014 |
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Target sample size:
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20 |
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Recruitment status: |
Not yet recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT02221544 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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N/A
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Countries of recruitment
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Israel
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Contacts
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Name:
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Nir Giladi, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Tel-Aviv Sourasky Medical Center |
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Name:
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Nir Giladi, MD |
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Address:
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Telephone:
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972-3-6974790 |
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Email:
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nirg@tlvmc.gov.il |
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Affiliation:
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Name:
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Nir Giladi, MD |
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Address:
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Telephone:
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972-3-6974790 |
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Email:
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nirg@tlvmc.gov.il |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Idiopathic Parkinson's disease (PD), as diagnosed by a neurologist.
2. The mini-mental state examination questionnaire score above 24 points.
3. Suffer from a disabling phenomenon called Freezing of Gait (FoG) (Freezing Of Gait
questionnaire score> = 10)
4. Negative responses to the Preliminary Safety Magnetic Stimulation Treatment
questionnaire.
Exclusion Criteria:
1. Other neurological or psychiatric disorders.
2. Severe personality disorder.
3. High Blood Pressure.
4. History of epilepsy, seizures or convulsions.
5. History of epilepsy or convulsions in first-degree relatives.
6. History of head injury or stroke.
7. Metal remains of the skull or inside the brain (outside the oral cavity).
8. Surgeries including metallic implants or known history of metal particles in the eye,
pacemakers, hearing devices transplantation, or medical pumps.
9. Current history of migraines for the last six months.
10. A history of drug or alcohol abuse
11. Other medical research in the time to experiment or three months ahead. -
Age minimum:
50 Years
Age maximum:
89 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Parkinson's Disease
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Intervention(s)
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Device: Low-frequency repetitive Transcranial Magnetic Stimulation
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Device: rTMS maintenance
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Device: Sham maintenance
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Device: Sham
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Primary Outcome(s)
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Changes in frequency and severity of the freezing of gait phenomenon
[Time Frame: One week post intervention]
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Secondary Outcome(s)
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Balance
[Time Frame: One week post intervention]
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Community ambulation
[Time Frame: One week post intervention]
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Immediate changes in blood pressure
[Time Frame: Every session, immediately after receiving the treatment]
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Changes in endurance
[Time Frame: One week post intervention]
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Immediate change in gait function
[Time Frame: One week post intervention]
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Secondary ID(s)
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TASMC-13-NG-599-CTIL
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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