Randomized Controlled Trial comparing imaging-based programming with threshold-assessment based programming of Deep Brain Stimulation in Parkinson's Disease.

Randomized Controlled Trial comparing imaging-based programming with threshold-assessment based programming of Deep Brain Stimulation in Parkinson's Disease. - DBS Imaging-based vs. Threshold-Assessment-based Programming (DBS-ITAP)

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON53191

Enrollment

132

Registered

2023-11-21

Start date

2024-01-03

Completion date

Unknown

Last updated

2025-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's Disease

Interventions

In both groups (i.e., Imaging and Threshold), DBS programming will start ±4 weeks after DBS surgery. For this programming patients are admitted in the hospital for a day. In the Imaging group, the

i.e., the tissue enclosed within an iso-surface of the activation function), the optimal parameters will be determined, and will be passed on to the nurse specialist that will program the DBS-syste

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Parkinson diagnosis based on the clinical diagnostic criteria of Movement Disorder Society Referred to Amsterdam UMC for DBS screening

Exclusion criteria

Exclusion criteria: Previous functional stereotactic neurosurgery Dementia Current depression or psychosis

Design outcomes

Primary

Measure	Time frame
The primary outcome is the mean change from baseline to six months follow-up on the Movement Disorders Society Unified Parkinson*s Disease Rating scale motor examination part (MDS-UPDRS III) score in standardized OFF-drug phase.	—

Secondary

Measure	Time frame
A. Motor symptoms in ON-drug phase (MDS-UPDRS III) B. Number of hours in OFF-drug phase (MDS-UPDRS IV) C. Dyskinesia duration and severity (MDS-UPDRS IV) D. Non-motor symptoms (MDS-UPDRS I) E. Motor aspects of experiences of daily living (MDS-UPDRS II) for OFF- and ON-drug phases F. Level of physical disability, measured with the Academic Medical Center Linear Disability Score (ALDS) G. Disease specific quality of life (Parkinson*s Disease Questionnaire 39) H. Adverse effects I. Patient satisfaction on the outcome of treatment J. Patient evaluation of the burden of therapy K. Proportion of patients for whom it is necessary to switch to the other intervention arm during the follow-up period L. Use of care (e.g., number of hospital visits and telephone calls) M.Total duration of programming sessions N. Final DBS settings (e.g., electrical current, pulse-width, and frequency) O. Proportion of patients at six months stimulated at same contact point (for both hemispheres) suggested by threshold assessment or imaging P. Local field potentials for patients with PerceptTM PC (Medtronic, Dublin, Ireland) DBS system (see chapter 5.1 and 6.2) Exploratory objectives also include the correlation between the assessment of PD symptoms and neuronal activity at the level of the STN at different time scales (seconds to minutes). This includes: A. The correlation of AI-based analysis of bradykinesia (a), tremor (b), dyskinesia (c) and freezing (d) in weekly home videos with the LFP data. B. The correlation of AI-based analysis of bradykinesia (a), tremor (b), dyskinesia (c) and freezing (d) in videos recorded during clinical practice with the LFP data. C. The change in LFPs due to DBS or medication. D. Difference between DBS responders (more than 30% improvement on MDS UPDRS III score), DBS superresponders (more than 70% improvement on MDS UPDRS III score), and DBS non-responders.	—

Measure

Time frame

A. Motor symptoms in ON-drug phase (MDS-UPDRS III) B. Number of hours in OFF-drug phase (MDS-UPDRS IV) C. Dyskinesia duration and severity (MDS-UPDRS IV) D. Non-motor symptoms (MDS-UPDRS I) E. Motor aspects of experiences of daily living (MDS-UPDRS II) for OFF- and ON-drug phases F. Level of physical disability, measured with the Academic Medical Center Linear Disability Score (ALDS) G. Disease specific quality of life (Parkinson*s Disease Questionnaire 39) H. Adverse effects I. Patient satisfaction on the outcome of treatment J. Patient evaluation of the burden of therapy K. Proportion of patients for whom it is necessary to switch to the other intervention arm during the follow-up period L. Use of care (e.g., number of hospital visits and telephone calls) M.Total duration of programming sessions N. Final DBS settings (e.g., electrical current, pulse-width, and frequency) O. Proportion of patients at six months stimulated at same contact point (for both hemispheres) suggested by threshold assessment or imaging P. Local field potentials for patients with PerceptTM PC (Medtronic, Dublin, Ireland) DBS system (see chapter 5.1 and 6.2) Exploratory objectives also include the correlation between the assessment of PD symptoms and neuronal activity at the level of the STN at different time scales (seconds to minutes). This includes: A. The correlation of AI-based analysis of bradykinesia (a), tremor (b), dyskinesia (c) and freezing (d) in weekly home videos with the LFP data. B. The correlation of AI-based analysis of bradykinesia (a), tremor (b), dyskinesia (c) and freezing (d) in videos recorded during clinical practice with the LFP data. C. The change in LFPs due to DBS or medication. D. Difference between DBS responders (more than 30% improvement on MDS UPDRS III score), DBS superresponders (more than 70% improvement on MDS UPDRS III score), and DBS non-responders.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)