SBIR-STTR Award

Pdremote: Automated Telehealth Diagnostics For Remote Parkinson's Monitoring
Award last edited on: 9/25/14

Sponsored Program
SBIR
Awarding Agency
NIH : NIMHD
Total Award Amount
$1,358,177
Award Phase
2
Solicitation Topic Code
-----

Principal Investigator
Joseph P Giuffrida

Company Information

Cleveland Medical Devices Inc (AKA: Orbital Research Inc~CleveMed)

4415 Euclid Avenue Suite 400
Cleveland, OH 44103
   (877) 253-8363
   N/A
   www.clevemed.com
Location: Single
Congr. District: 11
County: Cuyahoga

Phase I

Contract Number: 1R43MD004049-01
Start Date: 00/00/00    Completed: 00/00/00
Phase I year
2009
Phase I Amount
$199,385
The objective is to design, build, and clinically assess a system for automated telehealth diagnostics for remote Parkinson's disease (PD) monitoring. Currently in the United States, there are approximately 1 million patients living with PD and 50,000 new cases reported each year. However, there is limited access to movement disorder specialist centers for a significant portion of this population (Fig 2) as well as limited opportunity for remote continuous monitoring of motor symptoms to capture complex fluctuation patterns and optimize treatment protocols. The proposed PDRemote" system will integrate an existing advanced wireless movement disorder monitoring technology with a new infrastructure to remotely monitor PD patient symptoms. A repeatable, automated tool to more continuously monitor PD motor symptoms at home and remotely transmit severity reports to a clinician should improve outcomes and decrease costs for disparate patient populations not in close proximity to movement disorder specialists. Major PD symptoms include tremor, bradykinesia, and rigidity. Additionally, dyskinesias or wild involuntary movements as a side effect of drug therapy can be a motor complication. The current standard in evaluating symptoms is the Unified Parkinson's Disease Rating Scale (UPDRS), a qualitative ranking system. The UPDRS motor section includes several movements the patient completes to elicit motor symptoms while a clinician qualitatively assesses the symptoms with a 0 - 4 score. It is normally completed during an office visit to obtain a snapshot of motor symptom severity. Clinicians currently lack effective, affordable technologies that can be easily delivered to PD patients for monitoring symptoms on a more continuous basis as symptoms typically fluctuate during the day as a function of treatment parameters. CleveMed previously developed a compact wireless system to quantify movement disorder symptoms called Kinesia". This previously existing technology will serve as the hardware platform for this proposed program. With only minor hardware upgrades required to fit PDRemote and excellent clinical results to date, this existing base enhances likelihood of project success. While previous work has shown excellent results to objectively quantify symptoms during an in clinic exam, this proposed project will integrate several new features to translate this technology from the clinic to a patient's home. This will provide a clinically deployable evaluation tool that doctors can remotely order and then receive reports detailing a patient's PD symptom severity. The clinical technology resulting from this development will allow PD motor symptoms to be remotely monitored by clinicians on a more continuous basis. This should reduce costs and improve clinical outcomes by providing greater time resolution of symptom fluctuations and improving access to symptom monitoring for disparate populations in remote locations.

Public Health Relevance:
Parkinson's disease is primarily characterized by motor symptoms of tremor, bradykinesia (slowed movements), and rigidity which can be very debilitating, leading to decreased mobility, independence, and quality of life. Clinicians lack quantitative tools for more continuous monitoring that capture how motor symptoms fluctuate during the day in response to treatment protocols to help minimize Parkinson's motor symptoms. PDRemote" will be a repeatable, automated system clinicians will use to remotely monitor PD motor symptoms on a more continuous basis in a patient's home that should improve outcomes and decrease costs especially for disparate patient populations in areas not in close proximity to movement disorder specialists.

Public Health Relevance Statement:
Parkinson's disease is primarily characterized by motor symptoms of tremor, bradykinesia (slowed movements), and rigidity which can be very debilitating, leading to decreased mobility, independence, and quality of life. Clinicians lack quantitative tools for more continuous monitoring that capture how motor symptoms fluctuate during the day in response to treatment protocols to help minimize Parkinson's motor symptoms. PDRemote" will be a repeatable, automated system clinicians will use to remotely monitor PD motor symptoms on a more continuous basis in a patient's home that should improve outcomes and decrease costs especially for disparate patient populations in areas not in close proximity to movement disorder specialists.

NIH Spending Category:
Aging; Bioengineering; Brain Disorders; Clinical Research; Networking and Information Technology R&D; Neurodegenerative; Parkinson's Disease; Prevention

Project Terms:
Abnormal Movements; Adverse effects; Algorithms; Area; Bradykinesia; Care, Health; Case Study; Cell Transplants; Clinic; Clinical; Clinical Research; Clinical Study; Clinical Trials; Clinical Trials, Unspecified; Complex; Complication; Computer Programs; Computer software; Data; Deep Brain Stimulation; Development; Devices; Diagnosis; Diagnostic; Drug Therapy; Dysfunction; Dyskinesia Syndromes; Dyskinesias; Dyskinetic syndrome; Evaluation; Figs; Figs - dietary; Fingers; Functional disorder; Generalized Growth; Growth; Health; Healthcare; Home; Home environment; Housing; Human; Human, General; Idiopathic Parkinson Disease; Improve Access; Infrastructure; Intervention; Intervention Strategies; Involuntary Movements; Lewy Body Parkinson Disease; Life; Location; Man (Taxonomy); Man, Modern; Measures; Medical Technology; Memory; Minor; Modification; Monitor; Monitoring, Patient; Motion; Motor; Movement; Movement Disorder Syndromes; Movement Disorders; Movements, Involuntary; Muscle Rigidity; Office Visits; Outcome; Output; Paralysis Agitans; Parkinson; Parkinson Disease; Parkinson's; Parkinson's disease; Parkinsons disease; Patient Monitoring; Patients; Pattern; Pharmaceutical Agent; Pharmaceuticals; Pharmacologic Substance; Pharmacological Substance; Pharmacotherapy; Phase; Physiopathology; Population; Primary Parkinsonism; Process; Programs (PT); Programs [Publication Type]; Protocols, Treatment; QOL; Quality of life; Questionnaires; RGM; Radio; Regimen; Reporting; Research; Research Infrastructure; Resolution; Rigidity; Rigidity, Muscular; Severities; Software; Specialist; Symptoms; System; System, LOINC Axis 4; Technology; Technology, Medical; Testing; Time; Tissue Growth; Translating; Translatings; Translations; Transplants, Cell; Treatment Protocols; Treatment Regimen; Treatment Schedule; Treatment Side Effects; Tremor; United States; Visual; Wireless Technology; Work; Wrist; base; body movement; case report; clinical investigation; computer program/software; cost; data acquisition; data exchange; design; designing; fetus cell; health disparities; health disparity; improved; interventional strategy; language translation; ontogeny; pathophysiology; patient population; physician office visit; programs; prototype; public health relevance; response; side effect; success; telehealth; therapy adverse effect; tool; treatment adverse effect; wireless

Phase II

Contract Number: 5R43MD004049-02
Start Date: 9/30/09    Completed: 6/30/11
Phase II year
2010
(last award dollars: 2014)
Phase II Amount
$1,158,792

The objective is to design, build, and clinically assess a system for automated telehealth diagnostics for remote Parkinson's disease (PD) monitoring. Currently in the United States, there are approximately 1 million patients living with PD and 50,000 new cases reported each year. However, there is limited access to movement disorder specialist centers for a significant portion of this population (Fig 2) as well as limited opportunity for remote continuous monitoring of motor symptoms to capture complex fluctuation patterns and optimize treatment protocols. The proposed PDRemote" system will integrate an existing advanced wireless movement disorder monitoring technology with a new infrastructure to remotely monitor PD patient symptoms. A repeatable, automated tool to more continuously monitor PD motor symptoms at home and remotely transmit severity reports to a clinician should improve outcomes and decrease costs for disparate patient populations not in close proximity to movement disorder specialists. Major PD symptoms include tremor, bradykinesia, and rigidity. Additionally, dyskinesias or wild involuntary movements as a side effect of drug therapy can be a motor complication. The current standard in evaluating symptoms is the Unified Parkinson's Disease Rating Scale (UPDRS), a qualitative ranking system. The UPDRS motor section includes several movements the patient completes to elicit motor symptoms while a clinician qualitatively assesses the symptoms with a 0 - 4 score. It is normally completed during an office visit to obtain a snapshot of motor symptom severity. Clinicians currently lack effective, affordable technologies that can be easily delivered to PD patients for monitoring symptoms on a more continuous basis as symptoms typically fluctuate during the day as a function of treatment parameters. CleveMed previously developed a compact wireless system to quantify movement disorder symptoms called Kinesia". This previously existing technology will serve as the hardware platform for this proposed program. With only minor hardware upgrades required to fit PDRemote and excellent clinical results to date, this existing base enhances likelihood of project success. While previous work has shown excellent results to objectively quantify symptoms during an in clinic exam, this proposed project will integrate several new features to translate this technology from the clinic to a patient's home. This will provide a clinically deployable evaluation tool that doctors can remotely order and then receive reports detailing a patient's PD symptom severity. The clinical technology resulting from this development will allow PD motor symptoms to be remotely monitored by clinicians on a more continuous basis. This should reduce costs and improve clinical outcomes by providing greater time resolution of symptom fluctuations and improving access to symptom monitoring for disparate populations in remote locations.

Public Health Relevance:
Parkinson's disease is primarily characterized by motor symptoms of tremor, bradykinesia (slowed movements), and rigidity which can be very debilitating, leading to decreased mobility, independence, and quality of life. Clinicians lack quantitative tools for more continuous monitoring that capture how motor symptoms fluctuate during the day in response to treatment protocols to help minimize Parkinson's motor symptoms. PDRemote" will be a repeatable, automated system clinicians will use to remotely monitor PD motor symptoms on a more continuous basis in a patient's home that should improve outcomes and decrease costs especially for disparate patient populations in areas not in close proximity to movement disorder specialists.

Thesaurus Terms:
Abnormal Movements; Adverse Effects; Algorithms; Area; Bradykinesia; Care, Health; Case Study; Cell Transplants; Clinic; Clinical; Clinical Research; Clinical Study; Clinical Trials; Clinical Trials, Unspecified; Complex; Complication; Computer Programs; Computer Software; Data; Deep Brain Stimulation; Development; Devices; Diagnosis; Diagnostic; Drug Therapy; Dysfunction; Dyskinesia Syndromes; Dyskinesias; Dyskinetic Syndrome; Evaluation; Figs; Figs - Dietary; Fingers; Functional Disorder; Generalized Growth; Growth; Health; Healthcare; Home; Home Environment; Housing; Human; Human, General; Idiopathic Parkinson Disease; Improve Access; Infrastructure; Intervention; Intervention Strategies; Involuntary Movements; Lewy Body Parkinson Disease; Life; Location; Man (Taxonomy); Man, Modern; Measures; Medical Technology; Memory; Minor; Modification; Monitor; Motion; Motor; Movement; Movement Disorder Syndromes; Movement Disorders; Muscle Rigidity; Office Visits; Outcome; Output; Paralysis Agitans; Parkinson; Parkinson Disease; Parkinson's; Parkinson's Disease; Parkinsons Disease; Patient Monitoring; Patients; Pattern; Pharmaceutical Agent; Pharmaceuticals; Pharmacologic Substance; Pharmacological Substance; Pharmacotherapy; Phase; Physiopathology; Population; Primary Parkinsonism; Process; Programs (Pt); Programs [publication Type]; Protocols, Treatment; Qol; Quality Of Life; Questionnaires; Rgm; Radio; Regimen; Reporting; Research; Research Infrastructure; Resolution; Rigidity; Rigidity, Muscular; Severities; Software; Specialist; Symptoms; System; System, Loinc Axis 4; Technology; Testing; Time; Tissue Growth; Translating; Translatings; Translations; Treatment Protocols; Treatment Regimen; Treatment Schedule; Treatment Side Effects; Tremor; United States; Visual; Wireless Technology; Work; Wrist; Base; Body Movement; Case Report; Clinical Investigation; Computer Program/Software; Cost; Data Acquisition; Data Exchange; Design; Designing; Fetus Cell; Health Disparities; Health Disparity; Improved; Interventional Strategy; Language Translation; Ontogeny; Pathophysiology; Patient Population; Physician Office Visit; Programs; Prototype; Public Health Relevance; Response; Side Effect; Success; Telehealth; Therapy Adverse Effect; Tool; Treatment Adverse Effect; Wireless