Parkinson's DiseaseNCT01970891
Electrical Stimulation for the Relief of Freezing of Gait (FOG) in Parkinson's Patients
A study testing neuromuscular stimulation device in people with Parkinson's Disease, run by National University of Ireland, Galway, Ireland at 1 site in Ireland.
Trial summary
Potential for electrical stimulation to ameliorate Freezing of Gait (FOG) Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- neuromuscular stimulation device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteIreland
- Study dates
- 1 Oct 2013to 30 Nov 2020
- 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 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A diagnosis of idiopathic Parkinson's Disease (PD) (UK, PD Brain Bank Criteria)
- A Hoehn and Yahr stage of 2 - 4
- Exhibiting Freezing of Gait or another gait abnormality in the ON state.
- An ability to mobilise independently with or without a walker or walking cane for the purpose of research when in the 'ON' state
Who cannot join
- A serious cognitive impairment (MMSE<24)
- Pregnant or currently involved in another clinical trial.
- Pacemakers
- On opioid or neuropathic pain medication
Trial locations and contacts
1 site in 1 country.
Ireland1 site
Participants' home in the Mid-West region of Ireland
Limerick, IRL
About this study
Official title: Electrical Stimulation for the Relief of Freezing of Gait (FOG)
Potential for electrical stimulation to ameliorate Freezing of Gait (FOG)
Read the detailed description
The purpose of this study is to investigate the potential for an electrical stimulation intervention to ameliorate Freezing of Gait (FOG) and related gait disturbances in Parkinson's patients.
- Conditions
- Parkinson's Disease
- Being tested
- neuromuscular stimulation device
- Keywords
- Freezing of Gait, Gait, Comfort, Pain tolerance, Pain, Sensory threshold, Motor threshold, Pain threshold
- Medical subject headings
- Parkinson Disease, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neuromuscular stimulation deviceDevice
Effect of neuromuscular stimulation device at specific muscle sites will be examined for freezing of gait amelioration.
| Study group | Role | What they receive |
|---|---|---|
| Freezing of Gait amelioration | Experimental | Effect of neuromuscular stimulation device will be assessed on Freezing of Gait amelioration Receives: Device: neuromuscular stimulation device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Time in FoG PTF
We hypothesise that the delivery of continuous sensory electrical stimulation will reduce the percentage of time in FoG.
Measured: At time of intervention (seconds)
Number of FoG episodes occurring
We hypothesise that the delivery of continuous sensory electrical stimulation will reduce the Number of FoG episodes Occurring (NFO).
Measured: At time of intervention (seconds)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2013 (estimated)
- Study start1 Oct 2013
- Primary completion30 Nov 2020 (estimated)
- Study completion30 Nov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's 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
- Not applicable
- Intervention model
- Single group
- Model description
- Sensory electrical stimulation for the amelioration of FoG through the continuous delivery of stimulation.
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University of Ireland, Galway, Ireland
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital of Limerick
- Responsible party
- Principal investigator, Gearoid O Laighin, National University of Ireland, Galway, Ireland
- Investigators
- Gearóid Ó Laighin, PhD, Principal investigator, National University of Ireland, Galway, Ireland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01970891
- Sponsor's protocol ID
- NMES_PD_S_FOG
- Status last verified
- Sep 2020
- First submitted
- 19 Oct 2013
- Last updated
- 18 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrical Stimulation for the Relief of Freezing of Gait (FOG)
- ClinicalTrials.gov ID
- NCT01970891
- Acronym / sponsor ID
- NMES_PD_S_FOG
- Conditions
- Parkinson's Disease
- Keywords
- Freezing of Gait, Gait, Comfort, Pain tolerance, Pain, Sensory threshold, Motor threshold, Pain threshold
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (actual)
- Lead sponsor
- National University of Ireland, Galway, IrelandUniversity, hospital or other
- Collaborators
- University Hospital of Limerick
- Study start
- 1 Oct 2013 (actual)
- Primary completion
- 30 Nov 2020 (estimated)
- Study completion
- 30 Nov 2020 (estimated)
- First posted
- 28 Oct 2013 (estimated)
- 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.
Potential for electrical stimulation to ameliorate Freezing of Gait (FOG)
Detailed description
The purpose of this study is to investigate the potential for an electrical stimulation intervention to ameliorate Freezing of Gait (FOG) and related gait disturbances in Parkinson's patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Sensory electrical stimulation for the amelioration of FoG through the continuous delivery of stimulation.
| Arm | Type | Receives |
|---|---|---|
| Freezing of Gait amelioration | Experimental | Device: neuromuscular stimulation deviceEffect of neuromuscular stimulation device will be assessed on Freezing of Gait amelioration |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- A diagnosis of idiopathic Parkinson's Disease (PD) (UK, PD Brain Bank Criteria)
- A Hoehn and Yahr stage of 2 - 4
- Exhibiting Freezing of Gait or another gait abnormality in the ON state.
- An ability to mobilise independently with or without a walker or walking cane for the purpose of research when in the 'ON' state
Key exclusion criteria (4 listed)
- A serious cognitive impairment (MMSE<24)
- Pregnant or currently involved in another clinical trial.
- Pacemakers
- On opioid or neuropathic pain medication
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 |
|---|---|---|
| neuromuscular stimulation deviceEffect of neuromuscular stimulation device at specific muscle sites will be examined for freezing of gait amelioration. | Device | Freezing of Gait amelioration |
Primary outcome
Percentage of Time in FoG PTF
Time frame: At time of intervention (seconds)
We hypothesise that the delivery of continuous sensory electrical stimulation will reduce the percentage of time in FoG.
Number of FoG episodes occurring
Time frame: At time of intervention (seconds)
We hypothesise that the delivery of continuous sensory electrical stimulation will reduce the Number of FoG episodes Occurring (NFO).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2020.
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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.
Gearóid Ó Laighin, PhD principal investigator
National University of Ireland, Galway, Ireland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing neuromuscular stimulation device in people with Parkinson's Disease, run by National University of Ireland, Galway, Ireland at 1 site in Ireland.
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 4 inclusion and 4 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 18 Sep 2020. 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 Ireland. 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?
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?
Percentage of Time in FoG PTF (time frame: At time of intervention (seconds)). The study lists 2 primary outcomes in all. 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 18 Sep 2020.