Clinical trial NCT04831879: Automated Mechanical Peripheral Stimulation to Treat Freezing of Gait in Patients With Parkinson's Disease and STN-DBS
Official title: Automated Mechanical Peripheral Stimulation to Treat Freezing of Gait in Patients With Parkinson's Disease and Subthalamic Nucleus Deep Brain Stimulation (STN-DBS) - a Randomized Double-blind, Sham Controlled, Cross-over Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson Disease
Gait Disorders, Neurologic
Keywords: Freezing Of Gait
FOG
Deep Brain Stimulation
Parkinson Disease
Lead sponsor: Gondola Medical Technologies SA
Sponsor class: INDUSTRY
Collaborators: name: University of Cologne
First posted: 2021-04-05
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized sham-controlled cross-over trial
Primary purpose: TREATMENT

Brief summary: The objective is to investigate whether AMPS (Automated Mechanical Peripheral Stimulation) is effective in reduction of FOG measured via the FOG-AC (Freezing Of Gait Assessment Course) in people with Parkinson Disease and STN-DBS (Subthalamic Nucleus Deep Brain Stimulation) in a randomized, double-blind, sham-controlled, cross-over trial

Detailed description: The effects of AMPS treatment (effective vs sham) will be measured using the FOG-AC assessment. Patients will be randomized to receive either AMPS treatment and then sham or sham and then AMPS. Each treatment phase will be 4 weeks of treatment, separated by a 6-week washout period.

Eligibility criteria: Inclusion Criteria:

* Informed Consent as documented by signature (Appendix Informed Consent Form)
* ≥18 years old
* Diagnosis of Parkinson's Disease according to the United Kingdom Brain Bank Criteria
* Bilateral STN-DBS for at least 6 months
* Moderate to severe FOG i.e. FOG-AC ≥8 pts.

Exclusion Criteria:

* Known or suspected non-compliance, drug or alcohol abuse,
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, etc. of the participant,
* Participation in another study with investigational drug within the 30 days preceding and during the present study,
* Previous enrolment into the current study,
* Pregnancy
* Enrolment of the investigator, his/her family members, employees and other dependent persons,
* L-Dopa induced-freezing (defined by medical history),
* DBS-induced freezing (defined by medical history),
* Clinically relevant depression
* Clinically relevant cognitive impairments
* Shoe size greater than 46

Primary outcomes:
measure: Freezing of gait assessment course
timeFrame: 4 weeks
Secondary outcomes:
measure: Freezing of Gait Questionnaire
timeFrame: 4 weeks
measure: Timed up and go test
timeFrame: 4 weeks
measure: Movement Disorder Society - Unified Parkinson's Disease Rating Scale part I-IV
timeFrame: 4 weeks
measure: Parkinson's Disease Questionnaire
timeFrame: 4 weeks
measure: Clinical Global Impression Severity and Improvement Scores
timeFrame: 4 weeks
measure: Falls Efficacy Scale - International
timeFrame: 4 weeks
measure: Fast 360° turns
timeFrame: 4 weeks
measure: 30-meter walk
timeFrame: 4 weeks
Other outcomes:
measure: Parkinson Neuropsychometric Dementia Assessment
timeFrame: Duration of study, from screening to last follow-up visit, approximately 26 weeks
measure: Beck's Depression Inventory
timeFrame: Duration of study, from screening to last follow-up visit, approximately 26 weeks
measure: Levodopa equivalent daily dose
timeFrame: Throughout the duration of study, approximately 26 weeks
measure: Deep Brain Stimulation - Total Electrical Energy Delivered
timeFrame: Throughout the duration of study, approximately 26 weeks
Locations:
city: Köln
country: Germany
facility: Uniklinik Köln
state: North Rhine-Westphalia
Study officials:
affiliation: Department of Neurology, University Hospital Cologne
name: Michael Barbe, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stocchi F, Sale P, Kleiner AF, Casali M, Cimolin V, de Pandis F, Albertini G, Galli M. Long-term effects of automated mechanical peripheral stimulation on gait patterns of patients with Parkinson's disease. Int J Rehabil Res. 2015 Sep;38(3):238-45. doi: 10.1097/MRR.0000000000000120.
citation: Quattrocchi CC, de Pandis MF, Piervincenzi C, Galli M, Melgari JM, Salomone G, Sale P, Mallio CA, Carducci F, Stocchi F. Acute Modulation of Brain Connectivity in Parkinson Disease after Automatic Mechanical Peripheral Stimulation: A Pilot Study. PLoS One. 2015 Oct 15;10(10):e0137977. doi: 10.1371/journal.pone.0137977. eCollection 2015.
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citation: Pagnussat AS, Salazar AP, Pinto C, Redivo Marchese R, Rieder CRM, Alves Filho JO, Franco AR, Kleiner AFR. Plantar stimulation alters brain connectivity in idiopathic Parkinson's disease. Acta Neurol Scand. 2020 Sep;142(3):229-238. doi: 10.1111/ane.13253. Epub 2020 May 5.
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citation: Barbic F, Galli M, Dalla Vecchia L, Canesi M, Cimolin V, Porta A, Bari V, Cerri G, Dipaola F, Bassani T, Cozzolino D, Pezzoli G, Furlan R. Effects of mechanical stimulation of the feet on gait and cardiovascular autonomic control in Parkinson's disease. J Appl Physiol (1985). 2014 Mar 1;116(5):495-503. doi: 10.1152/japplphysiol.01160.2013. Epub 2014 Jan 16.
citation: Zamuner AR, Shiffer D, Barbic F, Minonzio M, Andrade CP, Corato M, Lalli S, Dipaola F, Cairo B, Albanese A, Porta A, Furlan R. Mechanical somatosensory stimulation decreases blood pressure in patients with Parkinson's disease. J Hypertens. 2019 Aug;37(8):1714-1721. doi: 10.1097/HJH.0000000000002084.