Algorithm Guided DBS Programming in Parkinson's Patients

NCT06205043 | Recruiting DMC FDA Device

• 1 other identifier: Stimulation Search
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Patients undergoing Deep Brain Stimulation for Parkinson's disease will be subjected to standard of care programming and compared with the algorithm based programming (StimSearch). Various parameters including the effectivity and efficiency of algorithm programming will be compared against the standard of care programming.

Conditions

Parkinson Disease

Keywords

Deep brain stimulation; Programming; Parkinson disease

Outcome Measures

Primary Outcomes (2)

• Comparison of efficacy between StimSearchTM-based programming and the best Standard of Care (SOC) based programming.

  Unified Parkinson's disease rating scale scores (part III) will be used to evaluate this. Range (0-132) The lower the score indicates lesser severity of the disease and improved outcome.

  4 weeks

• Comparison of time required between StimSearch and SOC programming

  Total time in minutes will recorded

  4 weeks

Secondary Outcomes (2)

• Comparison of volume of tissue activated (VTA) between StimSearch and SOC

  4 weeks

• Comparison of target volume between StimSearch and SOC

  4 weeks

Study Arms (2)

Standard of care (SoC) based programming in Parkinson's disease patients

ACTIVE COMPARATOR

Patients will be programmed in a routine (Standard of Care) program. Based on the randomization the patient may receive this at the beginning or after the Stim search program (crossover)

Device: Clinician based programming

StimSearchTM software based programing in Parkinson's disease patients

EXPERIMENTAL

Patients will be programmed using StimSearch algorithm. Based on the randomization the patient may receive this at the beginning or after the Standard of Care program (crossover)

Device: StimSearch programming algorithm software

Interventions

StimSearch programming algorithm software DEVICE

This is an algorithm based method to program deep brain stimulation in patients of Parkinson's disease

StimSearchTM software based programing in Parkinson's disease patients

Clinician based programming DEVICE

This is Standard of Care programming performed for patients undergoing deep brain stimulation for Parkinson's disease

Standard of care (SoC) based programming in Parkinson's disease patients

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Have a confirmed diagnosis of bilateral idiopathic Parkinson's disease
• Exhibit a UPDRS subset III score of ≥ 25 while in the preoperative medication off state
• Demonstrate an improvement of Parkinson's disease symptoms by ≥30% in the medication off state following a pre-operative levodopa challenge, as assessed by the UPDRS subset III score
• Possess the ability to comprehend the study's demands, treatment protocols, and procedures, and provide written informed consent before undergoing any study-specific tests or procedures

You may not qualify if:

• Patients with notable psychiatric conditions, including unrelated clinically substantial depression as assessed by the investigator, will be excluded from participation.

Sponsors & Collaborators

• Jaslok Hospital and Research Centre: lead
• Boston Scientific Corporation: collaborator

Study Sites (1)

Jaslok Hospital And Research Centre

Mumbai, Maharashtra, 400026, India

RECRUITING

Related Publications (3)

• Malekmohammadi M, Mustakos R, Sheth S, Pouratian N, McIntyre CC, Bijanki KR, Tsolaki E, Chiu K, Robinson ME, Adkinson JA, Oswalt D, Carcieri S. Automated optimization of deep brain stimulation parameters for modulating neuroimaging-based targets. J Neural Eng. 2022 Jul 20;19(4):10.1088/1741-2552/ac7e6c. doi: 10.1088/1741-2552/ac7e6c.

  PMID: 35790135 RESULT

• Sasaki F, Oyama G, Sekimoto S, Nuermaimaiti M, Iwamuro H, Shimo Y, Umemura A, Hattori N. Closed-loop programming using external responses for deep brain stimulation in Parkinson's disease. Parkinsonism Relat Disord. 2021 Mar;84:47-51. doi: 10.1016/j.parkreldis.2021.01.023. Epub 2021 Jan 30.

  PMID: 33556765 RESULT

• Wenzel GR, Roediger J, Brucke C, Marcelino ALA, Gulke E, Potter-Nerger M, Scholtes H, Wynants K, Juarez Paz LM, Kuhn AA. CLOVER-DBS: Algorithm-Guided Deep Brain Stimulation-Programming Based on External Sensor Feedback Evaluated in a Prospective, Randomized, Crossover, Double-Blind, Two-Center Study. J Parkinsons Dis. 2021;11(4):1887-1899. doi: 10.3233/JPD-202480.

  PMID: 34151855 RESULT

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

• Paresh Doshi, MCh

  Jaslok Hospital and Research Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paresh Doshi, MCh

CONTACT

+91 9820063854; pareshkd@gmail.com

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: Director of Neurosurgery and Stereotactic and Functional Neurosurgical program

Model Details: Patients will be randomized to receive either an algorithm based program vs standard of care program. After a period each group will cross over to the other side. UPDRS assessments will be done at each time.

Study Record Dates

• First Submitted: November 28, 2023
• First Posted: January 12, 2024
• Study Start: January 10, 2024
• Primary Completion: February 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: March 6, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)