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Parkinson's DiseaseNCT01423565

Comparison of Constant Current to Constant Voltage Stimulation in Subthalamic Deep Brain Stimulation for Parkinson's Disease

A study testing Deep Brain Stimulation (Medtronic, Activa PC) in people with Parkinson's Disease, run by Hadassah Medical Organization at 1 site in Israel.

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

HYPOTHESIS: Constant current stimulation for STN DBS will allow better and more stable control of Parkinson's disease symptoms than constant voltage stimulation. Subthalamic nucleus (STN) deep brain stimulation (DBS) is an established therapy for advanced Parkinson's disease (PD). Read more about this study

Who is it for?
Ages 30 to 80 years
Conditions the study is for
Parkinson's Disease
What is being tested?
Deep Brain Stimulation (Medtronic, Activa PC)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
1 siteIsrael
Study dates
Sep 2011to Mar 2012
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 30 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Idiopathic Parkinson's disease
  • Subthalamic Deep Brain Stimulation Surgery

Who cannot join

  • Any patient not meeting the inclusion criteria

Trial locations and contacts

1 site in 1 country.

Israel1 site
  • Hadassah University Hospital

    Jerusalem, 91120

Other trials in Israel

About this study

Official title: Comparison of Constant Current to Constant Voltage Stimulation in Subthalamic DBS for Parkinson's Disease

HYPOTHESIS: Constant current stimulation for STN DBS will allow better and more stable control of Parkinson's disease symptoms than constant voltage stimulation.

Subthalamic nucleus (STN) deep brain stimulation (DBS) is an established therapy for advanced Parkinson's disease (PD). Two types of implantable pulse generators (IPGs) are available, differing on whether voltage or electrical current is controlled. Constant current IPGs provide a specific electrical current and will automatically adjust the voltage depending on the impedance, while the current applied by constant voltage IPGs will depend on the tissue impedance that may change over time. No study has compared the clinical differences of these two electronic modalities.

Read the detailed description

Deep brain stimulation (DBS) is an established therapy for neurological and psychiatric disorders, being one of the most important therapies in functional neurosurgery to date. Class I evidence shows that subthalamic nucleus stimulation (STN) for Parkinson's disease (PD) is more effective than the best medical therapy (1,2). Globus pallidus internus stimulation for primary dystonia has an improvement rate of up to 70%(4) and is considered the main surgical treatment for this pathology. Symptom improvement in essential tremor is well documented. Pain, epilepsy, psychiatric disorders such as Tourette syndrome, obsessive - compulsive disorder and depression are promising applications of DBS. Obesity, memory improvement, aggressiveness, drug addiction, minimal conscious state and hypertension are areas of continuing investigation as potential applications of DBS.

The clinical effects of DBS result from the delivery of electrical charge to brain tissue. The way this electrical charge is delivered depends on the electronics of implantable pulse generators (IPGs). IPGs apply pulses of electrical stimulation in which voltage or current increases from zero to a maximum value for a period of time (order of tens of microseconds) and then returns to zero.

There are two types IPGs , differing on whether voltage or electrical current is controlled (3).

  1. Constant - voltage IPGs: in this type of IPG there is control over the maximum voltage associated with each pulse. The maximum current will vary depending on the impedance. A specific voltage is programmed. The amount of electrical current delivered with a constant voltage depends on the impedance of the tissue and the electrodes. Thus, the voltage will not indicate how much electrical current is given; the resistance will determine this parameter.
  2. Constant - current IPGs: provide a specific electrical current and will automatically adjust the voltage depending on the impedance. The strength of stimulation will remain the same regardless of changes in the impedance. The difference in impedances on each electrode and the intersubject variability in impedances will not alter the electrical current by modifying the voltage.

Until fairly recently, only constant voltage IPG's have been available for use. A newer generation of IPG's have been available for more than a year that can provide either constant voltage or constant current according to physician and patient preference. There is no evidence yet to support the preferential use of one modality over the other.

IMPORTANCE OF THE STUDY Following DBS electrode implantation, the impedances within the same patient can vary widely. Surgical implantation changes tissue impedance, being usually higher immediately after surgery. In this case the patient will require higher electrical currents. After the initial tissue reaction subsides, the reduction of impedance will generate an increase of the charge density. For this reason it is commonplace to wait at least 2 weeks after electrode implantation before programming the IPG.

Furthermore, different contacts on the same DBS lead can have widely varying impedances. Effects or side effects associated with stimulation of one electrode contact often cannot be applied to a different contact on the same DBS lead in the same patient because the impedances may differ.

The range of impedances that can be measured will depend on the choice of voltage. In some patients, the voltage used therapeutically may not be enough to allow an accurate measure of the impedances, causing confusion regarding the structural and electrical integrity of the IPG.

For all the above mentioned factors, the clinical results in patients with constant - voltage IPGs will depend on the experience of the operator to deal with the different aspects related to tissue and electrode impedances to achieve the desired current. The electronic properties of constant - current IPGs allows the system to make voltage adjustments in order to maintain the desired current and the subsequent clinical effect. This has been the theoretical background for the development of constant current IPG's; whether or not this theory is true in practice is the subject of this study.

Being tested
Deep Brain Stimulation (Medtronic, Activa PC)
Keywords
Deep Brain Stimulation, Parkinson's Disease, Subthalamic Nucleus, Constant Current
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 Stimulation (Medtronic, Activa PC)Device

    Also called Medtronic, Activa PC

    Following subthalamic nucleus deep brain stimulation patients will be randomized to receive either constant current or constant voltage stimulation and subsequently "crossed over" to receive the other type of stimulation

Study groups in NCT01423565
Study groupRoleWhat they receive
Deep Brain StimulationExperimentalNot described
Receives: Device: Deep Brain Stimulation (Medtronic, Activa PC)

What is being measured

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

  1. Impact of constant current on motor effects of STN DBS

    To assess any clinical impact of changing the electronic modality of IPGs from constant - voltage to constant - current in patients with advanced PD after STN stimulation in terms of motor examination according to the Unified Parkinson's Disease Rating Scale (UPDRS) III.

    Measured: 1 month

Secondary outcomes (1)
  1. Impact of constant current on psychocognitive affective status

    To assess the clinical impact of changing the electronic modality of IPGs from constant - voltage to constant - current in patients with advance PD after STN in terms of cognitive function, behavior, mood, quality of life and emotional processing according to the UPDRS I, UPDRS II, Hamilton Rating Scale for Depression (HAM-D17), Beck Depression Inventory (BDI), Clinical Global Inventory (CGI), Parkinson's disease questionnaire (PDQ-39), Addenbrooke's Cognitive Examination (ACE), Frontal Assessment Battery (FAB) and Hebrew version of the Montreal Affective Voices paradigm.

    Measured: 1 month

Timeline

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

  1. First posted26 Aug 2011 (estimated)
  2. Study startSep 2011
  3. Primary completionMar 2012
  4. Study completionMar 2012

Resources

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, Outcomes assessor
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01423565
Sponsor's protocol ID
386150-HMO-CTIL
Status last verified
Mar 2015
First submitted
23 Aug 2011
Last updated
18 Mar 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Deep Brain Stimulation (Medtronic, Activa PC) in people with Parkinson's Disease, run by Hadassah Medical Organization at 1 site in Israel.

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 2 inclusion and 1 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 18 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 1 site in Israel. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Impact of constant current on motor effects of STN DBS (time frame: 1 month). 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 Mar 2015.

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