Automated Mechanical Peripheral Stimulation to Treat Freezing of Gait in Patients With Parkinson's Disease and STN-DBS

Parkinson Disease Clinical Trial

— AMBITION  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04831879
• Other study ID #: UKK - AMBITION
• Status: Recruiting
• Phase: N/A
• Start date: March 25, 2021
• Est. completion date: June 30, 2022

Study information

• Verified date: April 2021
• Source: Gondola Medical Technologies SA
• Contact: Michael Barbe, MD
• Phone: 0221 478 7494
• Email: michael.barbe[@]uk-koeln.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 30, 2022
• Est. primary completion date: April 27, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gait Disorders, Neurologic
• Nervous System Diseases
• Parkinson Disease

Intervention

Device:
• GONDOLA AMPS
The Gondola device is composed of two units, one per foot, each having two motors that activate rounded stimulation tips that interact with the target points. It delivers mechanical, pressure-based stimulations, sequentially in each of the four points, for the duration of 6 seconds per point. This treatment cycle is repeated 4 times, for an overall treatment duration of less than 2 minutes

Locations

Country	Name	City	State
Germany	Uniklinik Köln	Köln	North Rhine-Westphalia

Sponsors (2)

Lead Sponsor	Collaborator
Gondola Medical Technologies SA	University of Cologne

Country where clinical trial is conducted

Germany, 

References & Publications (11)

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. — View Citation

Galli M, Vicidomini C, Rozin Kleiner AF, Vacca L, Cimolin V, Condoluci C, Stocchi F, De Pandis MF. Peripheral neurostimulation breaks the shuffling steps patterns in Parkinsonian gait: a double blind randomized longitudinal study with automated mechanical peripheral stimulation. Eur J Phys Rehabil Med. 2018 Dec;54(6):860-865. doi: 10.23736/S1973-9087.18.05037-2. Epub 2018 Feb 19. — View Citation

Kleiner A, Galli M, Gaglione M, Hildebrand D, Sale P, Albertini G, Stocchi F, De Pandis MF. The Parkinsonian Gait Spatiotemporal Parameters Quantified by a Single Inertial Sensor before and after Automated Mechanical Peripheral Stimulation Treatment. Parkinsons Dis. 2015;2015:390512. doi: 10.1155/2015/390512. Epub 2015 Oct 1. — View Citation

Kleiner AFR, Souza Pagnussat A, Pinto C, Redivo Marchese R, Salazar AP, Galli M. Automated Mechanical Peripheral Stimulation Effects on Gait Variability in Individuals With Parkinson Disease and Freezing of Gait: A Double-Blind, Randomized Controlled Trial. Arch Phys Med Rehabil. 2018 Dec;99(12):2420-2429. doi: 10.1016/j.apmr.2018.05.009. Epub 2018 Jun 11. — View Citation

Pagnussat AS, Kleiner AFR, Rieder CRM, Frantz A, Ehlers J, Pinto C, Dorneles G, Netto CA, Peres A, Galli M. Plantar stimulation in parkinsonians: From biomarkers to mobility - randomized-controlled trial. Restor Neurol Neurosci. 2018;36(2):195-205. doi: 10.3233/RNN-170744. — View 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. — View Citation

Pinto C, Pagnussat AS, Rozin Kleiner AF, Marchese RR, Salazar AP, Rieder CRM, Galli M. Automated Mechanical Peripheral Stimulation Improves Gait Parameters in Subjects With Parkinson Disease and Freezing of Gait: A Randomized Clinical Trial. Am J Phys Med Rehabil. 2018 Jun;97(6):383-389. doi: 10.1097/PHM.0000000000000890. — View Citation

Prusch JS, Kleiner AFR, Salazar AP, Pinto C, Marchese RR, Galli M, Pagnussat AS. Automated mechanical peripheral stimulation and postural control in subjects with Parkinson's disease and freezing of gait: a randomized controlled trial. Funct Neurol. 2018 Oct/Dec;33(4):206-212. — View 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. — View 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. — View Citation

Zamunér 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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Parkinson Neuropsychometric Dementia Assessment	PANDA Minimum value is 0, and the maximal raw scores of the subtests are associate learning immediate: 12, ?uency: no maximum, working memory: 6, spatial imagery: 3, associate learning delayed: 4. Higher score indicate lesser symptoms.	Duration of study, from screening to last follow-up visit, approximately 26 weeks
Other	Beck's Depression Inventory	BDI Min per scale: 0 Max per scale: 63 With higher score indicating worse symptoms.	Duration of study, from screening to last follow-up visit, approximately 26 weeks
Other	Levodopa equivalent daily dose	LEDD	Throughout the duration of study, approximately 26 weeks
Other	Deep Brain Stimulation - Total Electrical Energy Delivered	DBS TEED	Throughout the duration of study, approximately 26 weeks
Primary	Freezing of gait assessment course	The primary outcome is the change in FOG severity measured by the freezing of gait assessment course (FOG-AC) and evaluated by a blinded observer using video recordings (difference between the change after 4 weeks of effective AMPS treatment and after 4 weeks of sham-treatment).; Min: 0 Max: 36 Higher score indicates worse symptoms.	4 weeks
Secondary	Freezing of Gait Questionnaire	FOG-Q (difference between the change after 4 weeks of effective AMPS treatment and after 4 weeks of sham-treatment).; Min: 0 Max: 24 Higher score indicates worse symptoms.	4 weeks
Secondary	Timed up and go test	TUG (difference between the change after 4 weeks of effective AMPS treatment and after 4 weeks of sham-treatment).; Min: 16 Max: 64 Higher score indicates worse symptoms.	4 weeks
Secondary	Movement Disorder Society - Unified Parkinson's Disease Rating Scale part I-IV	MDS-UPDRS I-IV (difference between the change after 4 weeks of effective AMPS treatment and after 4 weeks of sham-treatment).; Minimum score for all sections is 0, with higher scores indicating worse symptoms. Maximum value per section: I: 44 II: 52 III: 108 IV: 24	4 weeks
Secondary	Parkinson's Disease Questionnaire	PDQ-39 (difference between the change after 4 weeks of effective AMPS treatment and after 4 weeks of sham-treatment) Min: 0 Max: 100 Higher score indicates worse symptoms.	4 weeks
Secondary	Clinical Global Impression Severity and Improvement Scores	CGI-S and CGI-I (difference between the change after 4 weeks of effective AMPS treatment and after 4 weeks of sham-treatment).; Min per scale: 1 Max per scale: 7 With higher score indicating worse symptoms.	4 weeks
Secondary	Falls Efficacy Scale - International	FES-I (difference between the change after 4 weeks of effective AMPS treatment and after 4 weeks of sham-treatment)	4 weeks
Secondary	Fast 360° turns	Detection of freezing of gait in patients with Parkinson's disease (difference between the change after 4 weeks of effective AMPS treatment and after 4 weeks of sham-treatment)	4 weeks
Secondary	30-meter walk	Assessment to measure walking speed, functional mobility, gait, and vestibular function. (difference between the change after 4 weeks of effective AMPS treatment and after 4 weeks of sham-treatment)	4 weeks

External Links

•   Sponsor website