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STUDY PROTOCOL
Year : 2016  |  Volume : 1  |  Issue : 3  |  Page : 91-98

Cortical physiology as a therapeutic target in Parkinson's disease related dementia and cognitive dysfunction: study protocol for a randomized controlled trial


Department of Neurology, University of Colorado-Anschutz Medical Campus, Aurora, CO, USA

Correspondence Address:
Benzi M Kluger
Department of Neurology, University of Colorado-Anschutz Medical Campus, Aurora, CO
USA
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Source of Support: This study was supported by grants from NIH/NINDS, No. 1K02NS080885-01A1 (to BMK)., Conflict of Interest: None


DOI: 10.4103/2468-5658.191351

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Background: Dementia is the leading cause of nursing home placement in Parkinson's disease (PD), yet little is known about the causes of cognitive dysfunction in PD and there are no effective treatments. Our preliminary data and other published studies suggest that abnormalities in brain activity involving networks important for normal thinking and memory may contribute to cognitive dysfunction in PD and may represent a target for treatment. Methods/Design: A randomized control trial will be conducted to assess the therapeutic potential of bifrontal repetitive transcranial magnetic stimulation (rTMS) in modulating cortical activity related to cognitive dysfunction in PD. This study will be performed at the University of Colorado Denver, Anschutz Campus, in Aurora, Colorado. Fifty-five PD patients (> 40 years of age) with mild cognitive impairment or mild dementia will be included and randomized in a 1:1 ratio to sham or real rTMS groups. Primary outcome measurement is the total score of the Mattis Dementia Rating Scale. Secondary outcome measurements are domain specific ratings of executive function, memory, language, attention, and visuospatial abilities. Discussion: If bifrontal rTMS results in positive changes to cognitive function in PD patients with mild cognitive impairment, this may represent a new and effective treatment for PD-related cognitive dysfunction. Secondly, evaluation of any bifrontal rTMS-induced changes to cognitive function will improve the current understanding of the mechanisms behind the causes of cognitive dysfunction in PD. Trial registration: Clinical Trials.gov identifier: NCT02346708; registered on 9 January 2015. Ethics: This study protocol was approved by the Colorado Multiple Institutional Review Board (COMIRB) (approval No. 13-2474) and will be performed in accordance with the Declaration of Helsinki. Informed consent: Signed informed consent will be obtained from the patients or their guardians.


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