Continuous Wearable Monitor for the Detection and Release of Freezing of Gait.

Parkinson Disease Clinical Trial

Official title:

Continuous Wearable Monitor for the Detection and Release of Freezing of Gait.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06385392
• Other study ID #: A23-354
• Status: Not yet recruiting
• Start date: May 2024
• Est. completion date: May 2025

Study information

• Verified date: April 2024
• Source: HealthPartners Institute
• Contact: Clarissa M Howe
• Phone: 651-495-6363
• Email: Clarissa.M.Howe[@]HealthPartners.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The proposed system (haptic module and insole device) for daily in-community use that detects the occurrence of freezing of gait (FOG) in people with Parkinson's disease (PD). and triggers external cueing stimuli to unfreeze the individual. The purpose of the overall Phase II study is to: (1) Develop a production ready system, (2) Develop a companion mobile app for the proposed system and refine previously developed FOG detection algorithms, and (3) Validate the proper operation of the system and demonstrate its efficacy through lab and in-community testing. This study will focus on validating the system and demonstrating efficacy through in-community testing.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 36
• Est. completion date: May 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 80 Years

Eligibility

Inclusion 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 New Freezing of Gait Questionnaire (NFOG).

• 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:

• 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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Device:
• Haptic module and insole device
System for use in daily in-community use that detects the occurrence of freezing of gait (FOG) and triggers external cueing stimuli to unfreeze the individual.

Locations

Country	Name	City	State
United States	Struthers Parkinson's Center	Golden Valley	Minnesota
United States	HealthPartners Neuroscience Center	Saint Paul	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
HealthPartners Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To validate the haptic module and insole device system and evaluate its efficacy with an in-community clinical trial.	Change in duration of FOG events. Decreased duration of FOG events indicates higher efficacy of device system.	5 weeks