Continuous wearable monitor for the detection and release of freezing of gait
Principal Investigator: Martha Nance, MD
Study sponsor: National Institute on Aging
Location: Center for Memory and Aging, Neuroscience Center, Struthers Parkinson’s Center
Phase of Study: I
Purpose of study: The purpose of the study is to test an insole and cueing device and determine whether it can reduce the number and length of FOG events in people living with PD. If you choose to participate, you will have an initial phone screening to evaluate your eligibility for the study, followed by two in-person visits and weekly phone calls over 5 weeks. You will also be given the insole device to take home and use within your home and the community for 5 weeks. Your participation will take approximately 7 weeks total, depending on when the in-person visits are scheduled.
Inclusion Criteria
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
-Ability to provide and provision of signed and dated informed consent form.
-Age 45-80
-Diagnosis of idiopathic PD, as determined by a movement disorders neurologist in accordance with the PD Society Brain Bank diagnostic criteria.
-Evidence of presence of freezing gait as a symptom. Determined from combination of clinical examination (observation of freezing) and NFOG-Q.
-Able to complete a 2-minute walk test at the pre-treatment visit.
-Currently on a stable prescription medication regimen for PD and willing to adhere to the regimen during the study.
-Ability to don and doff the insole and haptic module independently or have daily assistance during the study intervention.
Exclusion Criteria
An individual who meets any of the following criteria will be excluded from participation in this study:
-Non-English speaking
-History of musculoskeletal disorders that significantly affect movement of lower limbs as determined at the time of enrollment.
-Other significant neurological disorders that may affect participation or performance in the study.
-Neuropathy at the ankle assessed at the pre-treatment visit using the haptic module.
-Hallucinations
-Non-ambulatory
-Legally Blind
-Symptomatic hypotension
Study Contact:
Clarissa Howe
(651) 495-6368
Clarissa.M.Howe@HealthPartners.com
Intranasal Insulin in Parkinson’s Disease (INI-PD)
Principal Investigator: Julia Johnson, MD
Study Sponsor: Struthers’s Parkinson’s Center – Saint Paul, HealthPartners Neuroscience Center
Location: Struthers’s Parkinson’s Center – Saint Paul
Purpose of study: The purpose of this study is to investigate the safety and tolerability of insulin delivered as a nasal spray (intranasally) when administered to individuals with Parkinson’s disease (PD). In addition, the effect of intranasal insulin on motor function, cognitive function and mood in PD will be investigated.
There will be a total of three in-person study visits and at least two phone visits over the course of 2 months at the HealthPartners Neuroscience Center located at 295 Phalen Boulevard, St. Paul, MN 55130. Each participant is on the study medication or placebo for 3 weeks. A designated care partner/family member may be needed to be present for all 3 visits and to help with dosing every day, 1-2 times daily, for 3 weeks.
Inclusion Criteria:
– Diagnosis of Parkinson’s Disease
– Have previously undergone a brain CT or MRI as part of receiving a Parkinson’s diagnosis
–If needed, have a dedicated family member of caregiver who can attend all study visits
Exclusion Criteria:
–Currently taking insulin for diabetes or are allergic to insulin
–History of other central nervous system disorders
Study Contact:
(651) 495-6363
ClinicalTrials@HealthPartners.com
For more information, please visit the study’s clinicaltirals.gov site at:
https://clinicaltrials.gov/study/NCT04251585
Parkinson’s Foundation PD GENEration Genetic Registry
Principal Investigator: Martha Nance, MD
Study sponsor: Parkinson’s Foundation
Location: Struthers Parkinson’s Center
Purpose of study: Purpose: to help improve our understanding of Parkinson’s Disease and help participants and their clinicians understand their genetic status to improve care, which includes determining eligibility for clinical trial participation. Study includes a baseline visit (in-person or by video) and a genetic counseling visit (by video, phone, or in-person) to discuss your test results with the study doctor.
Inclusion Criteria:
– Diagnosis, or probable diagnosis, for Parkinson’s Disease.
– Capacity to give full informed consent.
– Participant must have residential address in MN or Wisconsin.
Exclusion Criteria:
– Received a blood transfusion within the past 3 months.
– Received a bone marrow transplant within the past 5 years.
– Active blood cancer, such as lymphoma or leukemia.
– Under the age of 18.
Study Contact
Renee Rosenberg
(651) 495-6363
ClinicalTrials@HealthPartners.com
For more information, please visit the study’s clinicaltirals.gov site at:
https://clinicaltrials.gov/study/NCT04994015
Randomized, Double-blind, Placebo-controlled Multicenter Study to Assess the Efficacy and Safety of Lenrispodun as Adjunctive Therapy in the Treatment of Patients with Motor Fluctuations due to Parkinson’s Disease
Principal Investigator: Sotirios Parashos, MD, PhD
Study Sponsor: Intra-Cellular Therapies, Inc.
Location: Struthers Parkinson’s Center – Golden Valley
Purpose of study: The purpose of this study is to compare the efficacy of lenrispodun 30 mg administered once daily as adjunctive therapy to stable doses of existing levodopa therapy with that of placebo as adjunctive therapy to stable doses of existing levodopa therapy in patients with motor fluctuations due to Parkinson’s disease.
Patients must:
-Be at least 40 years old
-Be diagnosed with Parkinson’s Disease
-Have a clinically meaningful response to levodopa
Carrie Weaver
(651) 495-6363
ClincialTrials@HealthPartners.com
For more information, please visit the study’s clinicaltrials.gov site at: https://clinicaltrials.gov/study/NCT05766813
