Parkinson DiseaseAMBITIONNCT04831879

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

A study testing GONDOLA AMPS in people with Parkinson Disease and Gait Disorders, Neurologic, run by Gondola Medical Technologies SA at 1 site in Germany.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Parkinson Disease, Gait Disorders, Neurologic
What is being tested?: GONDOLA AMPS
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 1 siteGermany
Study dates: 25 Mar 2021to 30 Jun 2022
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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,

Show all 11Show fewer

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

Trial locations and contacts

1 site in 1 country.

Michael Barbe, MD contact

0221 478 7494

michael.barbe@uk-koeln.de

Germany1 site, 1 recruiting

Uniklinik Köln
Cologne, North Rhine-Westphalia, 50937
Elfriede Stubbs, +49 221 478 98842, elfriede.stubbs@uk-koeln.de
Michael Barbe, Dr
Recruiting

Other trials in Germany

About this study

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

Read the 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.

Conditions: Parkinson Disease, Gait Disorders, Neurologic
Being tested: GONDOLA AMPS
Keywords: Freezing Of Gait, FOG, Deep Brain Stimulation, Parkinson Disease
Medical subject headings: Parkinson Disease, Gait Disorders, Neurologic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

GONDOLA AMPSDevice
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

Study groups in NCT04831879
Study group	Role	What they receive
Group A AMPS - sham	Experimental	Treatment phase 1: AMPS Treatment phase 2: sham Receives: Device: GONDOLA AMPS
Group B sham - AMPS	Experimental	Treatment phase 1: sham Treatment phase 2: AMPS Receives: Device: GONDOLA AMPS

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 4 weeks

Secondary outcomes (8)

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.
Measured: 4 weeks
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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 Mar 202130 Jun 2022

First posted5 Apr 2021
Study start25 Mar 2021
Primary completion27 Apr 2022 (estimated)
Study completion30 Jun 2022 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (11)Papers the sponsor has linked to this study.
Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Model description: Randomized sham-controlled cross-over trial
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 40 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04831879
Sponsor's protocol ID: UKK - AMBITION
Acronym: AMBITION
Status last verified: Apr 2021
First submitted: 25 Mar 2021
Last updated: 15 Apr 2021
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: No plan

Publications

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.
PubMed 26164797
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.
PubMed 26469868
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.
PubMed 30663967
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.
PubMed 29309313
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.
PubMed 32299120
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.
PubMed 29526852
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.
PubMed 29902470
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.
PubMed 26495152
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.
PubMed 29457707
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.
PubMed 24436294
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.
PubMed 31107357

Study at a glance

From the registry record, last updated by the sponsor on 15 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT04831879
Acronym / sponsor ID: AMBITION / UKK - AMBITION
Conditions: Parkinson Disease, Gait Disorders, Neurologic
Keywords: Freezing Of Gait, FOG, Deep Brain Stimulation, Parkinson Disease
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 40 participants (estimated)
Lead sponsor: Gondola Medical Technologies SAIndustry (pharma, biotech, devices)
Collaborators: University of Cologne
Study start: 25 Mar 2021 (actual)
Primary completion: 27 Apr 2022 (estimated)
Study completion: 30 Jun 2022 (estimated)
First posted: 5 Apr 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2
Model description: Randomized sham-controlled cross-over trial

Arm	Type	Receives
Group A AMPS - sham	Experimental	Device: GONDOLA AMPSTreatment phase 1: AMPS Treatment phase 2: sham
Group B sham - AMPS	Experimental	Device: GONDOLA AMPSTreatment phase 1: sham Treatment phase 2: AMPS

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (11 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
GONDOLA AMPSThe 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	Device	Group A AMPS - sham, Group B sham - AMPS

Primary outcome

Freezing of gait assessment course
Time frame: 4 weeks
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.

8 secondary outcomes

Freezing of Gait Questionnaire
Time frame: 4 weeks
Timed up and go test
Time frame: 4 weeks
Movement Disorder Society - Unified Parkinson's Disease Rating Scale part I-IV
Time frame: 4 weeks
Parkinson's Disease Questionnaire
Time frame: 4 weeks
Clinical Global Impression Severity and Improvement Scores
Time frame: 4 weeks
Falls Efficacy Scale - International
Time frame: 4 weeks
Fast 360° turns
Time frame: 4 weeks
30-meter walk
Time frame: 4 weeks

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2021.
Background: PubMed 26164797Stocchi 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.
Background: PubMed 26469868Quattrocchi 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.
Background: PubMed 30663967Prusch 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.
Background: PubMed 29309313Pinto 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.
Background: PubMed 32299120Pagnussat 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.
Background: PubMed 29526852Pagnussat 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.
Background: PubMed 29902470Kleiner 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.
Background: PubMed 26495152Kleiner 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.
Background: PubMed 29457707Galli 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.
Background: PubMed 24436294Barbic 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.
Background: PubMed 31107357Zamuner 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.
Sponsor websiteLink provided by the sponsor.
Individual participant dataSharing planned: No. No plan

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Michael Barbe, MD contact

0221 478 7494

michael.barbe@uk-koeln.de

Michael Barbe, MD principal investigator

Department of Neurology, University Hospital Cologne

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing GONDOLA AMPS in people with Parkinson Disease and Gait Disorders, Neurologic, run by Gondola Medical Technologies SA at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 15 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Michael Barbe, MD (0221 478 7494, michael.barbe@uk-koeln.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Freezing of gait assessment course (time frame: 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04831879, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2021; AzTrials last refreshed its copy on 8 Nov 2026.