Anodic Stimulation in Parkinson's Disease

NCT07798999 | Active Not Recruiting FDA Device

• 2 other identifiers: Study009369ISRNMB0048
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Randomized, double-blind, crossover design, interventional study to assess the differences between mixed cathodic/anodic, pure cathodic, and pure anodic stimulation with respect to efficacy, side effect thresholds, symptom control, and quality of life in Parkinson's Disease patients implanted with Boston Scientific Cartesia directional DBS leads in the bilateral STN.

Conditions

Parkinson Disease (PD)

Keywords

Parkinson Disease; DBS leads; Boston Scientific Vercise DBS system; Cartesia directional leads; Anodic; Cathodic

Outcome Measures

Primary Outcomes (1)

• Parkinson's Disease Questionnaire-39 (PDQ-39)

  Patient's preferred stimulation parameter setting (with or without anodic stimulation) determined by their responses to the questionnaire and patient's stated preference. The score ranges from 0-100, with lower scores reflecting better quality of life of patients.

  At the end of patient's participation in the study, 3 months.

Secondary Outcomes (11)

• Unified Parkinson's Disease Rating Scale (UPDRS) Part III Motor Scores

  Baseline and 4 weeks after each parameter setting.

• Unified Parkinson's Disease Rating Scale (UPDRS) Part III Motor Sub-scores

  Baseline and 4 weeks after each parameter setting.

• Clinical Global Impression- Positive Symptoms (CGI-P) Scores Mixed Cathodic/Anodic

  4 weeks following mixed cathodic/anodic stimulation.

• Clinical Global Impression- Positive Symptoms (CGI-P) Scores Pure Cathodic

  4 weeks following pure cathodic stimulation.

• Clinical Global Impression- Positive Symptoms (CGI-P) Scores Pure Anodic

  4 weeks following pure anodic stimulation.

Study Arms (3)

Mixed Cathodic/Anodic

EXPERIMENTAL

Device: Mixed Cathodic/Anodic

Cathodic

EXPERIMENTAL

Device: Pure Cathodic

Anodic

EXPERIMENTAL

Device: Pure Anodic

Interventions

Mixed Cathodic/Anodic DEVICE

Mixed cathodic/anodic stimulation setting on the Boston Scientific Vercise DBS system.

Mixed Cathodic/Anodic

Pure Cathodic DEVICE

Pure cathodic stimulation setting on the Boston Scientific Vercise DBS system.

Cathodic

Pure Anodic DEVICE

Pure anodic stimulation setting on the Boston Scientific Vercise DBS system.

Anodic

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients that are between the ages of 40-80 years of age.
• Patients diagnosed with Idiopathic Parkinson's Disease that are treated with bilateral STN DBS Boston Scientific Vercise Cartesia directional leads for at least 3 months.
• Patients whose DBS settings can be optimized to include anodic and cathodic stimulation.

You may not qualify if:

• Parkinson's Disease patients implanted with DBS leads outside of FDA labeling.
• Patients who are not chronically using anodic stimulation parameters.

Sponsors & Collaborators

• University of South Florida: lead
• Boston Scientific Corporation: collaborator

Study Sites (1)

USF Health STC Department of Neurosurgery and Tampa General Hospital

Tampa, Florida, 33606, United States

Location

Related Publications (7)

• Volkmann J, Moro E, Pahwa R. Basic algorithms for the programming of deep brain stimulation in Parkinson's disease. Mov Disord. 2006 Jun;21 Suppl 14:S284-9. doi: 10.1002/mds.20961.

  PMID: 16810675 BACKGROUND

• McIntyre CC, Grill WM. Extracellular stimulation of central neurons: influence of stimulus waveform and frequency on neuronal output. J Neurophysiol. 2002 Oct;88(4):1592-604. doi: 10.1152/jn.2002.88.4.1592.

  PMID: 12364490 BACKGROUND

• McIntyre CC, Grill WM. Selective microstimulation of central nervous system neurons. Ann Biomed Eng. 2000 Mar;28(3):219-33. doi: 10.1114/1.262.

  PMID: 10784087 BACKGROUND

• Kirsch AD, Hassin-Baer S, Matthies C, Volkmann J, Steigerwald F. Anodic versus cathodic neurostimulation of the subthalamic nucleus: A randomized-controlled study of acute clinical effects. Parkinsonism Relat Disord. 2018 Oct;55:61-67. doi: 10.1016/j.parkreldis.2018.05.015. Epub 2018 May 16.

  PMID: 29784559 BACKGROUND

• Deuschl G, Schade-Brittinger C, Krack P, Volkmann J, Schafer H, Botzel K, Daniels C, Deutschlander A, Dillmann U, Eisner W, Gruber D, Hamel W, Herzog J, Hilker R, Klebe S, Kloss M, Koy J, Krause M, Kupsch A, Lorenz D, Lorenzl S, Mehdorn HM, Moringlane JR, Oertel W, Pinsker MO, Reichmann H, Reuss A, Schneider GH, Schnitzler A, Steude U, Sturm V, Timmermann L, Tronnier V, Trottenberg T, Wojtecki L, Wolf E, Poewe W, Voges J; German Parkinson Study Group, Neurostimulation Section. A randomized trial of deep-brain stimulation for Parkinson's disease. N Engl J Med. 2006 Aug 31;355(9):896-908. doi: 10.1056/NEJMoa060281.

  PMID: 16943402 BACKGROUND

• De Jesus S, Almeida L, Shahgholi L, Martinez-Ramirez D, Roper J, Hass CJ, Akbar U, Wagle Shukla A, Raike RS, Okun MS. Square biphasic pulse deep brain stimulation for essential tremor: The BiP tremor study. Parkinsonism Relat Disord. 2018 Jan;46:41-46. doi: 10.1016/j.parkreldis.2017.10.015. Epub 2017 Oct 20.

  PMID: 29102253 BACKGROUND

• Anderson DN, Duffley G, Vorwerk J, Dorval AD, Butson CR. Anodic stimulation misunderstood: preferential activation of fiber orientations with anodic waveforms in deep brain stimulation. J Neural Eng. 2019 Feb;16(1):016026. doi: 10.1088/1741-2552/aae590. Epub 2018 Oct 2.

  PMID: 30275348 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Yarema Bezchlibnyk

  University of South Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Neurosurgery, Department of Neurosurgery, Brain and Spine

Model Details: Randomized, double-blind, crossover design, interventional study.

Study Record Dates

• First Submitted: June 20, 2026
• First Posted: September 2, 2026
• Study Start: February 17, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: September 2, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)