Freezing of GaitNCT03211260
Effects of Proprioceptive Focal Stimulation (EQUISTASI) on Freezing of Gait in Parkinson's Disease
A study testing EQUISTASI in people with Freezing of Gait and Parkinson Disease, run by ASST Gaetano Pini-CTO at 1 site in Italy.
Trial summary
Freezing of gait (FOG) is a common disabling condition in Parkinson's disease (PD), causes falls, and impairs quality of life. Therapeutic options for this symptom are limited and of limited efficacy. Besides, the pathophysiology has been not clarified yet. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Freezing of Gait, Parkinson Disease
- What is being tested?
- EQUISTASI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteItaly
- Study dates
- 11 Dec 2017to 19 Jul 2019
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient with Parkinson's Disease
- Stable drug therapy response without any change in the 3 months before the study.
- written informed consent
Who cannot join
- Hoehn-Yahr stage ≥ 4
- Cognitive decline (Mini Mental State Examination <26)
- Systemic illness involving the nervous system
- Diabetes
- Presence of cardiac pacemaker
- Presence of deep brain stimulation
Show all 9Show fewer
- Presence of severe dysautonomia with marked hypotension
- History or active neoplasia
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Proprioceptive Focal Stimulation (EQUISTASI) on Freezing of Gait in Parkinson's Disease: a Open, Single-arm Trial
Freezing of gait (FOG) is a common disabling condition in Parkinson's disease (PD), causes falls, and impairs quality of life. Therapeutic options for this symptom are limited and of limited efficacy. Besides, the pathophysiology has been not clarified yet. Proprioceptive sensitivity is likely to play a role and recent studies have reported that high-frequency microfocal vibratory stimulation exert a modulatory effect of proprioceptive reflex circuits and could be considered a valuable treatment strategy. However, evidence is not available. The present study was designed to collect preliminary evidence of efficacy of a vibrotactile device (Equistasi) for the treatment of FOG.
- Conditions
- Freezing of Gait, Parkinson Disease
- Being tested
- EQUISTASI
- Keywords
- Parkinson Disease, Freezing of gait, Equistasi
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EQUISTASIDevice
Equistasi is a nanotechnology for proprioceptive focal stimulation. Every patient will receive four patches to be placed on both legs for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| EQUISTASI | Experimental | Equistasi is a nanotechnology for proprioceptive focal stimulation. Every patient will receive four patches to be placed on both legs for 4 weeks. Receives: Device: EQUISTASI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freezing of gait questionnaire severity
Change in freezing of gait questionnaire score
Measured: 4 weeks
Secondary outcomes (4)
Gait and Falls Questionnaire (GFQ) score
Change in the GFQ score
Measured: 4 weeks
39-item Parkinson's Disease Questionnaire
Change in quality of life measured using the 39-item Parkinson's Disease Questionnaire
Measured: 4 weeks
Falls
Number of falls recorded during the intervention period
Measured: 4 weeks
Treatment continuation
Likelihood that patients would continue taking the trial treatment as assessed by a self-rating scale
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2017
- Study start11 Dec 2017
- Primary completion19 Jul 2019
- Study completion19 Jul 2019
Why it stopped: Iterim analysis did not detect a clinically meaningful change in the primary endpoint
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Freezing of GaitStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- ASST Gaetano Pini-CTO
- Sponsor type
- University, hospital or other
- Collaborators
- Grisons Foundation for Parkinson's Disease, Fondazione IRCCS Policlinico San Matteo di Pavia
- Responsible party
- Principal investigator, Gianni Pezzoli, ASST Gaetano Pini-CTO
- Investigators
- Gianni Pezzoli, MD, Principal investigator, Centro Parkinson, ASST Gaetano Pini-CTO di Milano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03211260
- Sponsor's protocol ID
- 319_2017bis
- Status last verified
- Sep 2019
- First submitted
- 2 Jul 2017
- Last updated
- 12 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Proprioceptive Focal Stimulation (EQUISTASI) on Freezing of Gait in Parkinson's Disease: a Open, Single-arm Trial
- ClinicalTrials.gov ID
- NCT03211260
- Acronym / sponsor ID
- 319_2017bis
- Conditions
- Freezing of Gait, Parkinson Disease
- Keywords
- Parkinson Disease, Freezing of gait, Equistasi
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Iterim analysis did not detect a clinically meaningful change in the primary endpoint
- Enrolment
- 42 participants (actual)
- Lead sponsor
- ASST Gaetano Pini-CTOUniversity, hospital or other
- Collaborators
- Grisons Foundation for Parkinson's Disease, Fondazione IRCCS Policlinico San Matteo di Pavia
- Study start
- 11 Dec 2017 (actual)
- Primary completion
- 19 Jul 2019 (actual)
- Study completion
- 19 Jul 2019 (actual)
- First posted
- 7 Jul 2017 (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.
Freezing of gait (FOG) is a common disabling condition in Parkinson's disease (PD), causes falls, and impairs quality of life. Therapeutic options for this symptom are limited and of limited efficacy. Besides, the pathophysiology has been not clarified yet. Proprioceptive sensitivity is likely to play a role and recent studies have reported that high-frequency microfocal vibratory stimulation exert a modulatory effect of proprioceptive reflex circuits and could be considered a valuable treatment strategy. However, evidence is not available. The present study was designed to collect preliminary evidence of efficacy of a vibrotactile device (Equistasi) for the treatment of FOG.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EQUISTASI | Experimental | Device: EQUISTASIEquistasi is a nanotechnology for proprioceptive focal stimulation. Every patient will receive four patches to be placed on both legs for 4 weeks. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patient with Parkinson's Disease
- Stable drug therapy response without any change in the 3 months before the study.
- written informed consent
Key exclusion criteria (9 listed)
- Hoehn-Yahr stage ≥ 4
- Cognitive decline (Mini Mental State Examination <26)
- Systemic illness involving the nervous system
- Diabetes
- Presence of cardiac pacemaker
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 |
|---|---|---|
| EQUISTASIEquistasi is a nanotechnology for proprioceptive focal stimulation. Every patient will receive four patches to be placed on both legs for 4 weeks. | Device | EQUISTASI |
Primary outcome
Freezing of gait questionnaire severity
Time frame: 4 weeks
Change in freezing of gait questionnaire score
4 secondary outcomes
Gait and Falls Questionnaire (GFQ) score
Time frame: 4 weeks
39-item Parkinson's Disease Questionnaire
Time frame: 4 weeks
Falls
Time frame: 4 weeks
Treatment continuation
Time frame: 4 weeks
Results and safety
The study was stopped early (reason given: Iterim analysis did not detect a clinically meaningful change in the primary endpoint). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Freezing of Gait
Recruiting
Decoding the Neural Mechanisms Underlying Postural Instability and Gait Dysfunction in Parkinson's Disease
Parkinson Disease, Freezing of Gait
Not yet recruiting
Function-based Accelerated Stimulation Therapy (FAST-therapy) for Freezing of Gait (FOG) After Parkinson's Disease (PD)
Parkinson Disease
Active, not recruitingPhase 2
Spinal Cord Stimulation for Freezing of Gait in Parkinson's Disease
Freezing of Gait, Parkinson Disease
RecruitingObservational study
Visuomotor Control in Parkinson Disease
Parkinson Disease
Recruiting
Correlation of STN-DBS Induced Visuospatial Changes and Freezing of Gait
Parkinson Disease, Gait Disorders, Neurologic
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.
Gianni Pezzoli, MD principal investigator
Centro Parkinson, ASST Gaetano Pini-CTO di Milano
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EQUISTASI in people with Freezing of Gait and Parkinson Disease, run by ASST Gaetano Pini-CTO at 1 site in Italy.
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 3 inclusion and 9 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: stopped early, as of the sponsor's last update on 12 Sep 2019. 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 Italy. 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?
The study was stopped early (reason given: Iterim analysis did not detect a clinically meaningful change in the primary endpoint). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freezing of gait questionnaire severity (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Sep 2019.