Parkinson DiseaseNCT06205043
Algorithm Guided DBS Programming in Parkinson's Patients
A study testing StimSearch programming algorithm software and Clinician based programming in people with Parkinson Disease, run by Jaslok Hospital and Research Centre at 1 site in India.
Trial 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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- StimSearch programming algorithm software and Clinician based programming
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIndia
- Study dates
- 10 Jan 2024to Jun 2026
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients with notable psychiatric conditions, including unrelated clinically substantial depression as assessed by the investigator, will be excluded from participation.
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Jaslok Hospital And Research Centre
Mumbai, Maharashtra, 400026
Sonali Vasnik, PhD, 02240173336, sonali.neuromodulation.21@gmail.com
Paresh K Doshi, MCh
About this study
Official title: Enhancing Deep Brain Stimulation Programming for Parkinson's Disease: A Semi- Automatic Algorithm-Guided Approach Using StimSearch- A Double Blind Randomized Study
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.
Read the detailed description
Patients of Parkinson's disease undergoing bilateral subthalamic nucleus stimulation (STN), we have already been adequately programmed and have achieved good outcome, will undergo an exploratory study to evaluate the effectiveness of algorithm based programming (Phase 1). Subsequently, patients undergoing STN DBS will be randomly allocated to algorithm based programming/ standard of care programming and after adequate stabilisation evaluated for motor improvement. They will be switched over to the alternative technique of programming and evaluated again after a similar period. Data regarding the time consumed, effectivity and several secondary endpoints will be evaluated.
- Conditions
- Parkinson Disease
- Being tested
- StimSearch programming algorithm software, Clinician based programming
- Keywords
- Deep brain stimulation, Programming, Parkinson disease
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StimSearch programming algorithm softwareDevice
This is an algorithm based method to program deep brain stimulation in patients of Parkinson's disease
Clinician based programmingDevice
This is Standard of Care programming performed for patients undergoing deep brain stimulation for Parkinson's disease
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: Device: StimSearch programming algorithm software |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
Comparison of time required between StimSearch and SOC programming
Total time in minutes will recorded
Measured: 4 weeks
Secondary outcomes (2)
Comparison of volume of tissue activated (VTA) between StimSearch and SOC
The volume of tissue activated in cubic millimeter will be calculated.
Measured: 4 weeks
Comparison of target volume between StimSearch and SOC
The target volume in cubic millimeter will be calculated.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2024
- Study start10 Jan 2024
- Primary completion1 Feb 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Parkinson 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jaslok Hospital and Research Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Scientific Corporation
- Responsible party
- Principal investigator, Paresh doshi, Jaslok Hospital and Research Centre
- Investigators
- Paresh Doshi, MCh, Principal investigator, Jaslok Hospital and Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06205043
- Sponsor's protocol ID
- Stimulation Search
- Status last verified
- Mar 2024
- First submitted
- 28 Nov 2023
- Last updated
- 6 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 35790135Sasaki 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.
PubMed 33556765Wenzel 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.
PubMed 34151855
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Deep Brain Stimulation Programming for Parkinson's Disease: A Semi- Automatic Algorithm-Guided Approach Using StimSearch- A Double Blind Randomized Study
- ClinicalTrials.gov ID
- NCT06205043
- Acronym / sponsor ID
- Stimulation Search
- Conditions
- Parkinson Disease
- Keywords
- Deep brain stimulation, Programming, Parkinson disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Jaslok Hospital and Research CentreUniversity, hospital or other
- Collaborators
- Boston Scientific Corporation
- Study start
- 10 Jan 2024 (actual)
- Primary completion
- 1 Feb 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 12 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Patients of Parkinson's disease undergoing bilateral subthalamic nucleus stimulation (STN), we have already been adequately programmed and have achieved good outcome, will undergo an exploratory study to evaluate the effectiveness of algorithm based programming (Phase 1). Subsequently, patients undergoing STN DBS will be randomly allocated to algorithm based programming/ standard of care programming and after adequate stabilisation evaluated for motor improvement. They will be switched over to the alternative technique of programming and evaluated again after a similar period. Data regarding the time consumed, effectivity and several secondary endpoints will be evaluated.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Standard of care (SoC) based programming in Parkinson's disease patients | Active comparator | Device: Clinician based programmingPatients 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) |
| StimSearchTM software based programing in Parkinson's disease patients | Experimental | Device: StimSearch programming algorithm softwarePatients 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) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Patients with notable psychiatric conditions, including unrelated clinically substantial depression as assessed by the investigator, will be excluded from participation.
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 |
|---|---|---|
| StimSearch programming algorithm softwareThis is an algorithm based method to program deep brain stimulation in patients of Parkinson's disease | Device | StimSearchTM software based programing in Parkinson's disease patients |
| Clinician based programmingThis is Standard of Care programming performed for patients undergoing deep brain stimulation for Parkinson's disease | Device | Standard of care (SoC) based programming in Parkinson's disease patients |
Primary outcome
Comparison of efficacy between StimSearchTM-based programming and the best Standard of Care (SOC) based programming.
Time frame: 4 weeks
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.
Comparison of time required between StimSearch and SOC programming
Time frame: 4 weeks
Total time in minutes will recorded
2 secondary outcomes
Comparison of volume of tissue activated (VTA) between StimSearch and SOC
Time frame: 4 weeks
Comparison of target volume between StimSearch and SOC
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
- Results publication: PubMed 35790135Malekmohammadi 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.
- Results publication: PubMed 33556765Sasaki 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.
- Results publication: PubMed 34151855Wenzel 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.
- Individual participant dataSharing planned: No
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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.
Paresh Doshi, MCh principal investigator
Jaslok Hospital and Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing StimSearch programming algorithm software and Clinician based programming in people with Parkinson Disease, run by Jaslok Hospital and Research Centre at 1 site in India.
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 4 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: status not confirmed, as of the sponsor's last update on 6 Mar 2024. 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 India. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paresh Doshi, MCh (+91 9820063854, pareshkd@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of efficacy between StimSearchTM-based programming and the best Standard of Care (SOC) based programming. (time frame: 4 weeks). The study lists 2 primary outcomes in all. 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 NCT06205043, which also lists 3 linked publications.
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 2024; AzTrials last refreshed its copy on 30 Oct 2026.