Evidence map›Paper›PMID 27000764›Full record

Trial reportNeuromodulation : journal of the International Neuromodulation Society2016

Randomized, Blinded Pilot Testing of Nonconventional Stimulation Patterns and Shapes in Parkinson's Disease and Essential Tremor: Evidence for Further Evaluating Narrow and Biphasic Pulses.

Umer Akbar, Robert S Raike, Nawaz Hack, Christopher W Hess, Jared Skinner, Daniel Martinez-Ramirez, Sol DeJesus, Michael S Okun

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Neuromodulation : journal of the International Neuromodulation Society, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07410598 (Safety and Tolerability of Patterned Stimulation for DBS in the Home Setting), which is not on this map. Cited by 35 papers.

0numbers the graph read from it
0cells of the map it votes in
35citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT07410598 narecruitingnot on this mapstarted 2026, after this paper: background citation

Safety and Tolerability of Patterned Stimulation for DBS in the Home Setting

TypeinterventionalSponsorUniversity of FloridaRan2026 to 2028Enrolled60ConditionsParkinson Disease, Deep Brain StimulationArmsBiphasic deep brain stimulation, Conventional deep brain stimulation, Theta burst deep brain stimulation, Multi frequency deep brain stimulation
3 · Its place in the literature

Who cites it

35 citing papers in PubMed.

  1. Article
  2. Pilot Study of Acute Behavioral Effects of Pallidal Burst Stimulation in Parkinson's Disease.Movement disorders : official journal of the Movement Disorder Society · 2024
    Article
  3. Review
  4. Article
  5. Review
  6. Article
  7. Article
  8. Review
  9. Review
  10. Article
  11. Review
  12. Article
  13. Article
  14. Wearable and Implantable Electroceuticals for Therapeutic Electrostimulations.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2021
    Review
  15. Review
  16. Review
  17. Article
  18. Article
  19. Article
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Umer AkbarUniversity of Florida Center for Movement Disorders and Neurorestoration, Gainesville, FL, USA.
Robert S RaikeNeuromodulation Global Research, Medtronic Inc., Minneapolis, MN, USA.
Nawaz HackUniversity of Florida Center for Movement Disorders and Neurorestoration, Gainesville, FL, USA.
Christopher W HessUniversity of Florida Center for Movement Disorders and Neurorestoration, Gainesville, FL, USA.
Jared SkinnerUniversity of Florida Center for Movement Disorders and Neurorestoration, Gainesville, FL, USA.
Daniel Martinez-RamirezUniversity of Florida Center for Movement Disorders and Neurorestoration, Gainesville, FL, USA.
Sol DeJesusUniversity of Florida Center for Movement Disorders and Neurorestoration, Gainesville, FL, USA.
Michael S OkunUniversity of Florida Center for Movement Disorders and Neurorestoration, Gainesville, FL, USA.

Funding

Together: Transforming and Translating Discovery to Improve HealthKL2TR001429 · NCATS · UNIVERSITY OF FLORIDA · PI GUIRGIS, FAHEEM W, LEEUWENBURGH, CHRISTIAAN · 2015 to 2023
$5.5M
Mobile Decision Support System for Nurse Management of Neuromodulation TherapyR01NR014852 · NINR · UNIVERSITY OF UTAH · PI BUTSON, CHRISTOPHER R, OKUN, MICHAEL S · 2015 to 2019
$2.9M
NCATS NIH HHS KL2 TR001429NINR NIH HHS R01 NR014852
6 · The paper itself

Abstract

objectivesEvidence suggests that nonconventional programming may improve deep brain stimulation (DBS) therapy for movement disorders. The primary objective was to assess feasibility of testing the tolerability of several nonconventional settings in Parkinson's disease (PD) and essential tremor (ET) subjects in a single office visit. Secondary objectives were to explore for potential efficacy signals and to assess the energy demand on the implantable pulse-generators (IPGs). MATERIALS AND

methodsA custom firmware (FW) application was developed and acutely uploaded to the IPGs of eight PD and three ET subjects, allowing delivery of several nonconventional DBS settings, including narrow pulse widths, square biphasic pulses, and irregular pulse patterns. Standard clinical rating scales and several objective measures were used to compare motor outcomes with sham, clinically-optimal and nonconventional settings. Blinded and randomized testing was conducted in a traditional office setting.

resultsOverall, the nonconventional settings were well tolerated. Under these conditions it was also possible to detect clinically-relevant differences in DBS responses using clinical rating scales but not objective measures. Compared to the clinically-optimal settings, some nonconventional settings appeared to offer similar benefit (e.g., narrow pulse widths) and others lesser benefit. Moreover, the results suggest that square biphasic pulses may deliver greater benefit. No unexpected IPG efficiency disadvantages were associated with delivering nonconventional settings.

conclusionsIt is feasible to acutely screen nonconventional DBS settings using controlled study designs in traditional office settings. Simple IPG FW upgrades may provide more DBS programming options for optimizing therapy. Potential advantages of narrow and biphasic pulses deserve follow up.

Indexed as

AgedBiophysical PhenomenaCohort StudiesDeep Brain StimulationEnergy MetabolismEssential TremorGlobus PallidusHumansMiddle AgedParkinson DiseasePilot ProjectsStatistics, NonparametricTreatment OutcomeBiphasic pulsesdeep brain stimulationessential tremorirregular patternsnarrow pulse widthParkinson's disease

Identifiers

PMID27000764
PMCPMC4914444

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.