Parkinson's DiseaseNCT02022735

Deep Brain Stimulation Effects on Gait and Balance in Patients With Parkinson's Disease

A study testing Deep Brain Stimulator in people with Parkinson's Disease, run by University of Miami at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The purpose of this study is to evaluate the effect of Deep Brain stimulation (DBS) on walking in patients with Parkinson's disease that have had DBS. While DBS improves Parkinson's disease (PD) symptoms and walking in many patients in some of the patients walking problems persist. Read more about this study

Who is it for?: Ages 45 to 70 years
Conditions the study is for: Parkinson's Disease
What is being tested?: Deep Brain Stimulator
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 22 participants
Where: 1 siteUnited States
Study dates: 1 Sep 2013to 1 Dec 2017
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 45 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients with idiopathic Parkinson's disease stage 1-3 that underwent subthalamic nucleus (STN) Deep Brain Stimulation (DBS) and have walking difficulties 6-12 months after DBS.
On stable dose of dopaminergic drugs
Age 45-70 years of age

Who cannot join

Past medical history of seizures
Renal insufficiency
Cardiac arrhythmia
Severe arthritis
Women of childbearing potential
Dementia
Less than 45 years of age or older than 70 years of age

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Miami
Miami, Florida, 33136

Other trials in United States

About this study

Conditions: Parkinson's Disease
Being tested: Deep Brain Stimulator
Keywords: Deep Brain Stimulation
Medical subject headings: Parkinson Disease

What participants receive

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

Deep Brain StimulatorDevice
Also called DBS
DBS will provide brain stimulation.

Study groups in NCT02022735
Study group	Role	What they receive
Bilateral stimulation	Experimental	Participants will receive Deep Brain Stimulation Bilaterally. Receives: Device: Deep Brain Stimulator
Left stimulation	Experimental	Participants will receive Deep Brain Stimulation on the left side only Receives: Device: Deep Brain Stimulator
Right stimulation	Experimental	Participants will receive Deep Brain Stimulation on the right side only Receives: Device: Deep Brain Stimulator
Off stimulation	No intervention	Participants will receive no brain stimulation

What is being measured

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

Walking Speed
Walking speed will be measured using sensors reported in meter per second.
Measured: Up to 1 hour

Secondary outcomes (3)

Stride Length
Stride length will be measured using sensors and will be reported in meters.
Measured: Up to 1 hour
UPDRS Scores
Unified Parkinson's disease rating Scale (UPDRS) has a total score ranging from 0-108 with the highest score indicating worse condition.
Measured: Up to 1 hour
TUG Test
Time Up and Go (TUG) Test reports the time it takes for participant to stand up from chair, walk around a cone and return to chair.
Measured: Up to 1 hour

Timeline

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

1 Sep 20131 Dec 2017

First posted30 Dec 2013 (estimated)
Study start1 Sep 2013
Primary completion1 Dec 2017
Study completion1 Dec 2017

Why it stopped: Funding not secured

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
More trials run by University of MiamiThe sponsor's other registered studies.
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
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 22 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02022735
Sponsor's protocol ID: 20130225
Status last verified: May 2021
First submitted: 5 Dec 2013
Last updated: 28 May 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
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Adaptive DBS to Offset STN Dysregulation During Exercise in PD
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Compulsive Eating and Brain's Reward System in Different Pathologies
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Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)

All Parkinson's Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 28 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Deep Brain Stimulation Effects on Gait and Balance in Patients With Parkinson's Disease
ClinicalTrials.gov ID: NCT02022735
Acronym / sponsor ID: 20130225
Conditions: Parkinson's Disease
Keywords: Deep Brain Stimulation
Study type: Interventional
Recruitment status: TerminatedReason stopped: Funding not secured
Enrolment: 22 participants (actual)
Lead sponsor: University of MiamiUniversity, hospital or other
Study start: 1 Sep 2013
Primary completion: 1 Dec 2017 (actual)
Study completion: 1 Dec 2017 (actual)
First posted: 30 Dec 2013 (estimated)
Results: Posted 1 Apr 2021

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
Bilateral stimulation	Experimental	Device: Deep Brain StimulatorParticipants will receive Deep Brain Stimulation Bilaterally.
Left stimulation	Experimental	Device: Deep Brain StimulatorParticipants will receive Deep Brain Stimulation on the left side only
Right stimulation	Experimental	Device: Deep Brain StimulatorParticipants will receive Deep Brain Stimulation on the right side only
Off stimulation	No intervention	–Participants will receive no brain stimulation

Who may qualify

Ages: 45 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Patients with idiopathic Parkinson's disease stage 1-3 that underwent subthalamic nucleus (STN) Deep Brain Stimulation (DBS) and have walking difficulties 6-12 months after DBS.
On stable dose of dopaminergic drugs
Age 45-70 years of age

Key exclusion criteria (7 listed)

Past medical history of seizures
Renal insufficiency
Cardiac arrhythmia
Severe arthritis
Women of childbearing potential

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
Deep Brain StimulatorAlso: DBSDBS will provide brain stimulation.	Device	Bilateral stimulation, Left stimulation, Right stimulation

Primary outcome

Walking Speed
Time frame: Up to 1 hour
Walking speed will be measured using sensors reported in meter per second.

3 secondary outcomes

Stride Length
Time frame: Up to 1 hour
UPDRS Scores
Time frame: Up to 1 hour
TUG Test
Time frame: Up to 1 hour

Results and safety

Results posted to the registry on 1 Apr 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Participants	22	22

Primary outcome: Walking Speed

Time frame: Up to 1 hour. Mean (Standard Deviation). Unit: meter per second

Measure	Bilateral Stimulation n = 22	Left Stimulation n = 22	Right Stimulation n = 22	OFF Stimulation n = 22
Value	0.95 (0.05)	0.90 (0.05)	0.92 (0.05)	0.84 (0.07)

Population analysed: All participants completed all 4 arms in the cross over study design.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 7 hours. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Bilateral Stimulation	0 of 22 (0%)	0 of 22 (0%)	0 of 22
Left Stimulation	0 of 22 (0%)	0 of 22 (0%)	0 of 22
Right Stimulation	0 of 22 (0%)	0 of 22 (0%)	0 of 22
OFF Stimulation	0 of 22 (0%)	0 of 22 (0%)	0 of 22

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Parkinson's Disease

Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
Active, not recruitingPhase 1/2
Clinical Safety and Efficacy of Umbilical Cord Mesenchymal Stromal Cells-derived Exosomes in Patients With Parkinson's Disease
Parkinson Disease (PD)
Active, not recruitingObservational study
Adaptive DBS to Offset STN Dysregulation During Exercise in PD
Parkinson Disease
Not yet recruiting
Compulsive Eating and Brain's Reward System in Different Pathologies
PARKINSON DISEASE (Disorder), Bipolar 1 Disorder
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)

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.

Corneliu Luca, MD, PhD principal investigator

University of Miami

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

Questions about this trial

What is this clinical trial studying?

A study testing Deep Brain Stimulator in people with Parkinson's Disease, run by University of Miami at 1 site in United States.

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 7 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 28 May 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 United States. 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?

Yes. Results are posted in the registry (first posted 1 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Walking Speed (time frame: Up to 1 hour). 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 NCT02022735.

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 28 May 2021.