Parkinson's DiseasePhase 4RECHARGENCT00998660

RECHARGE Sub-Study to the Implantable Systems Performance Registry (ISPR)

A Phase 4 study testing Activa RC in people with Parkinson's Disease and Essential Tremor, run by MedtronicNeuro at 11 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to assess the recharge feature of the Activa RC System in patients who are receiving Deep Brain Stimulation (DBS) for Parkinson's Disease (PD), Essential Tremor (ET), or dystonia. Read more about this study

Who is it for?: Ages 7 years and older
Conditions the study is for: Parkinson's Disease, Essential Tremor, Dystonia
What is being tested?: Activa RC
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 participants
Where: 11 sitesin 6 countries
Study dates: Jul 2009to Jul 2013
Phase: Phase 4
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 7 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Patient is enrolled in the Implantable Systems Performance Registry (ISPR) and will receive one Activa RC as their first implantable neurostimulator or as a replacement implantable neurostimulator for DBS.
Patient must meet the indications in the Activa RC labeling.
Patient (or patient's legally authorized representative) signs and dates the appropriate RECHARGE Informed Consent Form and/or Informed Assent Form and Authorization to Use and Disclose Health Information (HIPAA, US only).
Patient has a diagnosis of Parkinson's Disease, Essential Tremor, or dystonia that meets the approved indication for Activa RC in the applicable geography.
Patient with dystonia is 7 years of age or older (EU only).
Patient with either PD or ET is 18 years of age or older.

Show all 11Show fewer

Patient (or caregiver) is able to use the patient programmer and correctly interpret the icons.
Patient (or caregiver) is able and willing to regularly monitor the status of the rechargeable battery and respond appropriately.
Patient (or caregiver) is able to locate the INS, position the recharge antenna for sufficient coupling, put on the recharge holster/belt, and monitor progress during the recharge session.
Patient (or caregiver) is able to perform recharging activities for sufficient duration and frequency to maintain therapy and to perform recharging activities on an ongoing basis.
Patient is willing and able to comply with protocol requirements.

Who cannot join

Patient has a contraindication identified in the Activa RC labeling.
Patient who is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound the results of the RECHARGE study.
Patient has or will be implanted with a non-Medtronic Deep Brain Stimulation system component.

Trial locations and contacts

11 sites in 6 countries.

Country

City, postcode or hospital

11 sites in 6 countries

United States5 sites

Study site
Cincinnati, Ohio
Study site
Houston, Texas
Study site
Nashville, Tennessee
Study site
Tyler, Texas, 75701
Study site
Washington D.C., District of Columbia

Other trials in United States

Germany2 sites

Study site
Cologne
Study site
Hanover

Other trials in Germany

Austria1 site

Study site
Vienna

Other trials in Austria

France1 site

Study site
Montpellier

Other trials in France

Spain1 site

Study site
Barcelona

Other trials in Spain

United Kingdom1 site

Study site
Oxford

Other trials in United Kingdom

About this study

Conditions: Parkinson's Disease, Essential Tremor, Dystonia
Being tested: Activa RC
Keywords: Parkinson's disease, Essential Tremor, Dystonia (where indication is approved), Deep brain stimulation, Activa RC
Medical subject headings: Parkinson Disease, Essential Tremor, Dystonia

What participants receive

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

Activa RCDevice
Patients receiving Activa RC as their first implantable neurostimulator or as a replacement implantable neurostimulator for deep brain stimulation

Study groups in NCT00998660
Study group	Role	What they receive
Patients receiving an Activa RC implant	Experimental	Not described Receives: Device: Activa RC

What is being measured

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

Identify the Rate of User-related Battery Depletion Adverse Events Per Subject-month Requiring Intervention by a Health Care Professional (HCP) and/or the HCP's Designee, Within the First 3 Months of the Activa RC System Being Turned ON.
Subject-months of follow-up were defined as the time from device activation to the earlier of a subject's 3-month visit or until the subject exited from the study. Any user-related battery depletion adverse events requiring intervention by a health care professional (HCP) and/or the HCP's designee were collected. The event rate per 100 subject-months of follow-up is defined as the number of user-related battery depletion events divided by the total subject follow-up months through the 3-month visit, all multiplied by 100.
Measured: 3 months

Timeline

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

Jul 2009Jul 2013

First posted20 Oct 2009 (estimated)
Study startJul 2009
Primary completionJul 2013
Study completionJul 2013

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.
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 4
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00998660
Sponsor's protocol ID: 1649
Acronym: RECHARGE
Status last verified: Feb 2015
First submitted: 12 Oct 2009
Last updated: 6 Mar 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: 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

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All Parkinson's Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: RECHARGE Sub-Study to the Implantable Systems Performance Registry (ISPR)
ClinicalTrials.gov ID: NCT00998660
Acronym / sponsor ID: RECHARGE / 1649
Conditions: Parkinson's Disease, Essential Tremor, Dystonia
Keywords: Parkinson's disease, Essential Tremor, Dystonia (where indication is approved), Deep brain stimulation, Activa RC
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: MedtronicNeuroIndustry (pharma, biotech, devices)
Study start: Jul 2009
Primary completion: Jul 2013 (actual)
Study completion: Jul 2013 (actual)
First posted: 20 Oct 2009 (estimated)
Results: Posted 6 Mar 2015

Clinical summary

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

Study design

Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Patients receiving an Activa RC implant	Experimental	Device: Activa RC

Who may qualify

Ages: 7 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (11 listed)

Patient is enrolled in the Implantable Systems Performance Registry (ISPR) and will receive one Activa RC as their first implantable neurostimulator or as a replacement implantable neurostimulator for DBS.
Patient must meet the indications in the Activa RC labeling.
Patient (or patient's legally authorized representative) signs and dates the appropriate RECHARGE Informed Consent Form and/or Informed Assent Form and Authorization to Use and Disclose Health Information (HIPAA, US only).
Patient has a diagnosis of Parkinson's Disease, Essential Tremor, or dystonia that meets the approved indication for Activa RC in the applicable geography.
Patient with dystonia is 7 years of age or older (EU only).

Key exclusion criteria (3 listed)

Patient has a contraindication identified in the Activa RC labeling.
Patient who is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound the results of the RECHARGE study.
Patient has or will be implanted with a non-Medtronic Deep Brain Stimulation system component.

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
Activa RCPatients receiving Activa RC as their first implantable neurostimulator or as a replacement implantable neurostimulator for deep brain stimulation	Device	Patients receiving an Activa RC implant

Primary outcome

Identify the Rate of User-related Battery Depletion Adverse Events Per Subject-month Requiring Intervention by a Health Care Professional (HCP) and/or the HCP's Designee, Within the First 3 Months of the Activa RC System Being Turned ON.
Time frame: 3 months
Subject-months of follow-up were defined as the time from device activation to the earlier of a subject's 3-month visit or until the subject exited from the study. Any user-related battery depletion adverse events requiring intervention by a health care professional (HCP) and/or the HCP's designee were collected. The event rate per 100 subject-months of follow-up is defined as the number of user-related battery depletion events divided by the total subject follow-up months through the 3-month visit, all multiplied by 100.

Results and safety

Results posted to the registry on 6 Mar 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Patients Receiving an Activa RC Implant	100	87

Primary outcome: Identify the Rate of User-related Battery Depletion Adverse Events Per Subject-month Requiring Intervention by a Health Care Professional (HCP) and/or the HCP's Designee, Within the First 3 Months of the Activa RC System Being Turned ON.

Time frame: 3 months. Number (95% Confidence Interval). Unit: Event rate per 100 subject-months

Measure	Patients Implanted With the Activa RC n = 93
Value	0.00 (0.00 to 1.30)

Population analysed: The 93 implanted subjects accumulated 283.6 subject-months of follow-up through the 3-month visit. There were no reported user-related battery depletion adverse events that required an intervention by a health care professional and/or HCP designee.

Adverse events

Time frame: Adverse event data were collected from Activa RC implant through discontinuation (maximum of 6 months).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Patients Implanted With the Activa RC	9 of 93 (9.7%)	0 of 93 (0%)	Not reported

Limitations and caveats (from the sponsor): Potential limitations of the study include the limited sample size to fully characterize recharge use by indication. In addition, inferences to a broader population should also be limited given the relatively short duration of the study.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

ISPR Team study chair

Medtronic

11 sites in 6 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Activa RC in people with Parkinson's Disease and Essential Tremor, run by MedtronicNeuro at 11 sites in 6 countries.

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 11 inclusion and 3 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: finished, as of the sponsor's last update on 6 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in United States, Germany, Austria, France, Spain and 1 more country. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Mar 2015). 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?

Identify the Rate of User-related Battery Depletion Adverse Events Per Subject-month Requiring Intervention by a Health Care Professional (HCP) and/or the HCP's Designee, Within the First 3 Months of the Activa RC System Being Turned ON. (time frame: 3 months). 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 NCT00998660.

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 6 Mar 2015.