Optimizing patient selection for deep brain stimulation of the subthalamic nucleus in Parkinson*s disease: the OPTIMIST study

Optimizing patient selection for deep brain stimulation of the subthalamic nucleus in Parkinson*s disease: the OPTIMIST study - OPTIMIST

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON42986

Enrollment

Registered

2016-11-30

Start date

2017-05-02

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Parkinson's disease shaking palsy

Interventions

Deep brain stimulation

Parkinson's disease

Patient selection

Predictive factors

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: - Age >18 years. - Diagnosis of idiopathic Parkinson's disease according to established criteria. - Clinical indication for STN DBS at the participating centre. - Ability to give informed consent. - Ability to comply with the study assessments. - Ability to read or understand Dutch.

Exclusion criteria

Exclusion criteria: There are no specific exclusion criteria for this study other than exclusion criteria that pertain to contra-indications for STN-DBS, which are the following: - PD severity graded according to Hoehn & Yahr stage 5. - Score on Mattis Dementia Rating scale

Design outcomes

Primary

Measure	Time frame
The main endpoint in this study is the response to STN DBS as measured by an acute stimulation challenge performed 12 months after surgery, defined as the percentage change of MDS-UPDRS motor score after overnight medication withdrawal between off-stimulation and on-stimulation. We will compare the accuracy of the three models (described under Objectives) in predicting this primary endpoint. In all models the effect of pertinent covariates and variability between centres will be taken into account.	—

Measure

Time frame

The main endpoint in this study is the response to STN DBS as measured by an acute stimulation challenge performed 12 months after surgery, defined as the percentage change of MDS-UPDRS motor score after overnight medication withdrawal between *off*-stimulation and *on*-stimulation. We will compare the accuracy of the three models (described under Objectives) in predicting this primary endpoint. In all models the effect of pertinent covariates and variability between centres will be taken into account.

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Secondary

Measure	Time frame
- the occurrence of psychotic symptoms in the 72 hours following surgery, as measured by a score >=3 on the delirium observation scale (DOS). - the change in quality of life after surgery, the Global satisfaction with surgery scale and the number of contacts (outpatient visits, telephone calls, emails) with the hospital team (neurologists, parkinson nurses) in the first year. - the SENS-PD score and MDS-UPDRS motor score. - the cognitive decline 12 months after surgery, as defined by either a) the transition to mild cognitive impairment or PD-related dementia diagnosed according to criteria proposed by the Movement Disorders Society, or b) a reduction in MoCA score >3 points.	—

Measure

Time frame

- the occurrence of psychotic symptoms in the 72 hours following surgery, as measured by a score >=3 on the delirium observation scale (DOS). - the change in quality of life after surgery, the *Global satisfaction with surgery* scale and the number of contacts (outpatient visits, telephone calls, emails) with the hospital team (neurologists, parkinson nurses) in the first year. - the SENS-PD score and MDS-UPDRS motor score. - the cognitive decline 12 months after surgery, as defined by either a) the transition to mild cognitive impairment or PD-related dementia diagnosed according to criteria proposed by the Movement Disorders Society, or b) a reduction in MoCA score >3 points.

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Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)