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| Name | Class |
|---|---|
| University of Cologne | OTHER |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A AMPS - sham | Experimental | Treatment phase 1: AMPS Treatment phase 2: sham |
|
| Group B sham - AMPS | Experimental | Treatment phase 1: sham Treatment phase 2: AMPS |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GONDOLA AMPS | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Timed up and go test |
| Measure | Description | Time Frame |
|---|---|---|
| Parkinson Neuropsychometric Dementia Assessment | PANDA Minimum value is 0, and the maximal raw scores of the subtests are associate learning immediate: 12, fluency: 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michael Barbe, MD | Contact | 0221 478 7494 | michael.barbe@uk-koeln.de |
| Name | Affiliation | Role |
|---|---|---|
| Michael Barbe, MD | Department of Neurology, University Hospital Cologne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Uniklinik Köln | Recruiting | Cologne | North Rhine-Westphalia | 50937 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26164797 | Background | 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. | |
| 26469868 | Background | 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. |
| Label | URL |
|---|---|
| Sponsor website | View source |
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No plan
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D020233 | Gait Disorders, Neurologic |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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Randomized sham-controlled cross-over trial
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|
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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Levodopa equivalent daily dose | LEDD | Throughout the duration of study, approximately 26 weeks |
| Deep Brain Stimulation - Total Electrical Energy Delivered | DBS TEED | Throughout the duration of study, approximately 26 weeks |
| 30663967 | Background | 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. |
| 29309313 | Background | 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. |
| 32299120 | Background | 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. |
| 29526852 | Background | 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. |
| 29902470 | Background | 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. |
| 26495152 | Background | 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. |
| 29457707 | Background | 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. |
| 24436294 | Background | 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. |
| 31107357 | Background | 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. |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |