Using Neuromodulation to Improve Parkinson's Disease

NCT04493697 | Withdrawn FDA Device

• 1 other identifier: IRB00067408WD
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a single-site, double-blinded, placebo-controlled, randomized clinical trial designed to elucidate mechanism(s) of action for symptomatic benefits observed in Parkinson's disease (PD) patients treating twice daily time-varying caloric vestibular stimulation treatment using a solid-state device. Study participants will self-administer treatments in the home setting over a period of 12 weeks. Changes in cerebral blood flow perfusion, cerebrovascular reactivity and functional connectivity between the pre-treatment baseline and the end of the treatment period will be monitored and will be compared to changes in validated standardized clinical measures of motor and non-motor symptoms in PD. The durability of effects will be evaluated at a post-treatment assessment conducted five weeks after treatment cessation.

Conditions

Parkinson Disease

Keywords

Parkinson Disease; Motor/Non-Motor Symptoms; Neurovascular Symptoms

Outcome Measures

Primary Outcomes (5)

• Neuroimaging

  Brain data will be acquired with Siemens MAGNETOM Skyra 3T MRI - range measured by statistically significant change in cerebral blood flow (CBF) measured in units of mL/100g/min

  Baseline

• Neuroimaging

  Brain data will be acquired with Siemens MAGNETOM Skyra 3T MRI - range measured by statistically significant change in cerebral blood flow (CBF) measured in units of mL/100g/min

  Week 12

• Neuroimaging

  Brain data will be acquired with Siemens MAGNETOM Skyra 3T MRI - range measured by statistically significant change in cerebral blood flow (CBF) measured in units of mL/100g/min

  Week 17

• Transcranial Doppler Sonography

  Non-invasive ultrasound used to examine blood circulation within the brain - range measured by statistically significant change in mean cerebral blood flow velocity (cm/s)

  Baseline

• Transcranial Doppler Sonography

  Non-invasive ultrasound used to examine blood circulation within the brain - range measured by statistically significant change in mean cerebral blood flow velocity (cm/s)

  Week 12

Secondary Outcomes (8)

• MDS-Unified Parkinson's Disease Rating Scale

  Baseline, Week 12, Week 17

• Timed Up and Go Test

  Baseline, Week 12, Week 17

• Montreal Cognitive Assessment

  Baseline, Week 12, Week 17

• Non-Motor Symptom Scale

  Baseline, Week 12, Week 17

• Geriatric Depression Scale

  Baseline, Week 12, Week 17

Study Arms (2)

Experimental 1

ACTIVE COMPARATOR

A ThermoNeuroModulation device will be worn by the participant that delivers warm waveforms in one ear (42 °C) and cool waveforms (17 °C) in the other ear.

Device: Experimental 1

Experimental 2

PLACEBO COMPARATOR

A ThermoNeuroModulation device will be worn by the participant that will neither warm nor cool.

Device: Experimental 2

Interventions

Experimental 1 DEVICE

A ThermoNeuroModulation device will be worn by the participant that delivers warm waveforms in one ear (42 °C) and cool waveforms (17 °C) in the other ear.

Experimental 1

Experimental 2 DEVICE

A ThermoNeuroModulation device will be worn by the participant that will neither warm nor cool.

Experimental 2

Eligibility Criteria

• Age: 21 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must be 21-85 years old.
• Diagnosed with Parkinson's Disease (meeting UK PD Society Brain Bank criteria)
• Responsive to oral DRT (dopamine replacement therapy) for a minimum of 3 years and on a stable dose of therapy
• Must be able to voluntarily give written informed consent
• Must have ability to reliably use the investigational device
• Must be able to understand and complete all assessments (provided in English only) within a given on-state period
• Must be willing and able to undertake a \~1 hour imaging session in a MRI magnet with a head coil in place during 3 separate clinic visits.
• Must have a home partner and/or regular caregiver
• Must have capability to complete assessments using telemedicine platforms.
• Must demonstrate moderate burden of motor symptoms and non-motor symptoms in PD ( MDS-UPDRS part II \>12 and MDS-UPDRS part I scores \>10)

You may not qualify if:

• Pregnant women.
• Have experienced a heart attack, angina or stroke within the past 12 months,
• Use of medications that regulate heart rate
• Have a history or prior diagnosis of dementia or adjusted score ≤ 20 on the Montreal Cognitive Exam at the baseline visit.
• Those receiving deep brain stimulation
• Treated with a pump for continuous delivery of DRT (Dopamine replacement therapy)
• Use of Apomorphine rescue
• Works night shifts
• Have a major concomitant illness or illnesses including cancer or disease of the cardiovascular, respiratory and/or renal systems
• Has history or evidence of unstable mood disorder, or responds affirmatively to question #9 on the BDI-II (any score \> 0 on suicidal thoughts or wishes). Participants that respond affirmatively to this question should receive a referral for mental health counseling according to the mandates of the IRB or ethics review committee.
• Those with hearing aids or cochlear implants, chronic tinnitus, temporomandibular joint disease
• Those who have persistent negative sequela of a traumatic brain injury
• Those who have been diagnosed with another neurological illness with the exceptions of restless leg syndrome and REM behavioral sleep disorder
• Those with a recent history of substance abuse and/or dependence (alcohol or other drugs)
• Those who have a diagnosed vestibular dysfunction and/or balance dysfunction

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• Michael J. Fox Foundation for Parkinson's Research: collaborator

Study Sites (1)

Wake Forest Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Christopher T Whitlow, MD

  Wake Forest Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The device uses a bar code reader to import a prescription waveform. The use of the bar code aids blinding during randomization since the QR code is not readable by study members.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All participants will receive a ThermoNeuroModulation device for in-home use. Participants will be randomized to either the active or placebo treatment arm.

Study Record Dates

• First Submitted: July 23, 2020
• First Posted: July 30, 2020
• Study Start: September 1, 2020
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2022
• Last Updated: October 14, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)