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Adaptive Portable Essential Tremor Monitor
This study has been completed.
Sponsor:
Great Lakes NeuroTechnologies Inc.
Collaborators:
Rush University Medical Center
Baylor College of Medicine
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Great Lakes NeuroTechnologies Inc.
ClinicalTrials.gov Identifier:
NCT01602042
First received: May 16, 2012
Last updated: December 3, 2012
Last verified: December 2012
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Purpose
The purpose of this study is to evaluate the utility of a portable motion sensor-based system designed to monitor essential tremor (ET) to better prescribe therapy to minimize symptoms and expand care for ET patients.
| Condition |
|---|
| Essential Tremor |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Phase II Study: Adaptive Portable Essential Tremor Monitor |
Resource links provided by NLM:
Genetics Home Reference related topics:
essential tremor
MedlinePlus related topics:
Tremor
U.S. FDA Resources
Further study details as provided by Great Lakes NeuroTechnologies Inc.:
Primary Outcome Measures:
- Tremor ratings during activities of daily living versus standardized tasks. [ Time Frame: 10 hours each day the sensor is worn. ]
| Enrollment: | 20 |
| Study Start Date: | May 2012 |
| Study Completion Date: | November 2012 |
| Primary Completion Date: | November 2012 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Essential tremor
Criteria
Inclusion Criteria:
- Aged 18 years or older
- Clinical diagnosis of essential tremor
- Able to provide informed consent
Exclusion Criteria:
- Significant medical or psychiatric illness
- Not capable of following the required clinical instructions
- Serious medical conditions that compromise safety
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: NCT01602042
Please refer to this study by its ClinicalTrials.gov identifier: NCT01602042
Locations
| United States, Illinois | |
| Rush University Medical Center | |
| Chicago, Illinois, United States, 60612 | |
| United States, Texas | |
| Baylor College of Medicine | |
| Houston, Texas, United States, 77030 | |
Sponsors and Collaborators
Great Lakes NeuroTechnologies Inc.
Rush University Medical Center
Baylor College of Medicine
National Institute on Aging (NIA)
Investigators
| Principal Investigator: | Dustin A Heldman, PhD | CleveMed Inc. also dba Great Lakes NeuroTechnologies |
More Information
| Responsible Party: | Great Lakes NeuroTechnologies Inc. |
| ClinicalTrials.gov Identifier: | NCT01602042 History of Changes |
| Other Study ID Numbers: |
2R44AG034708-02A1 ( U.S. NIH Grant/Contract ) |
| Study First Received: | May 16, 2012 |
| Last Updated: | December 3, 2012 |
Keywords provided by Great Lakes NeuroTechnologies Inc.:
|
essential tremor motion sensors tremor |
Additional relevant MeSH terms:
|
Tremor Essential Tremor Dyskinesias Neurologic Manifestations |
Nervous System Diseases Signs and Symptoms Movement Disorders Central Nervous System Diseases |
ClinicalTrials.gov processed this record on September 21, 2017