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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.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT02441985
Date of registration: 08/05/2015
Prospective Registration: Yes
Primary sponsor: University of Florida
Public title: rTMS Therapy for Primary Orthostatic Tremor
Scientific title: rTMS Therapy for Primary Orthostatic Tremor: A Novel Treatment Approach
Date of first enrolment: August 2015
Target sample size: 11
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02441985
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Outcomes Assessor).  
Phase:  N/A
Countries of recruitment
United States
Contacts
Name:     Aparna Wagle-Shukla, M.D.
Address: 
Telephone:
Email:
Affiliation:  Center for Movement Disorders and Neurorestoration
Key inclusion & exclusion criteria

Inclusion Criteria:

- Potential participants will be diagnosed with Primary orthostatic tremor (POT) and be
recruited through IRB approved database maintained by the Movement Disorders Center

Exclusion Criteria:

- Pregnancy

- Active seizure disorder

- Significant cognitive impairment

- Presence of a metallic body such as pacemaker, implants, prosthesis,artificial limb or
joint, shunt, metal rods and hearing aid



Age minimum: 30 Years
Age maximum: 75 Years
Gender: All
Health Condition(s) or Problem(s) studied
Primary Orthostatic Tremor
Intervention(s)
Other: 10m walk test
Other: Timed "Up & Go" Test (TUG) test
Other: Tremor electrophysiology
Device: Sham Magstim RapidStim2
Other: Cerebellar-brain Inhibition (CBI)
Device: Magstim RapidStim2
Other: Fahn-Tolosa-Marin Tremor Rating Scale (TRS)
Primary Outcome(s)
10m walk test [Time Frame: Day 1]
Fahn-Tolosa-Marin Tremor Rating Scale (TRS) [Time Frame: Day 1]
Timed "Up & Go" Test (TUG) test [Time Frame: Day 1]
Secondary Outcome(s)
TMS measure [Time Frame: Baseline to 60 Minutes]
Tremor electrophysiology [Time Frame: Day 1]
Secondary ID(s)
IRB201500347
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
National Organization for Rare Disorders
Neuronetics
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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