Select Stim: Selective stimulation of the subthalamic nucleus in Parkinson*s disease "A feasability study"

Select Stim: Selective stimulation of the subthalamic nucleus in Parkinson*s disease "A feasability study" - Select Stim

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON33676

Enrollment

Registered

2008-06-09

Start date

2008-09-10

Completion date

Unknown

Last updated

2024-05-13

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

Conditions

Parkinson disease Parkinsonism

Interventions

The intervention is an expansion of the classical STN DBS procedure. The targeting using the multichannel registration system by stimulation of the motor cortex and registration of the subthalamic n

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients with the clinical findings consistent with idiopathic Parkinson Disease (PD) and who suffer from severe response fluctuations and/or dyskinesias, despite optimal drug treatment, who are candidates for DBS.

Exclusion criteria

Exclusion criteria: Those PD patients suffering from severe psychiatric co-morbidities and cognitive decline, e.g. dementia and psychosis, are excluded from this study. The mini mental state exam (MMSE) score is not allowed to be

Design outcomes

Primary

Measure	Time frame
There are two main endpoints to measure the feasibility. First, the patients burden and outcome. We will interview the patient and ask him to fill in a standardized questionnaire. Only if the burden is acceptable, we will start with the main study (average marks for each testing must be above 5 to continue with a RCT). Thereby the motor symptoms must be significantly less pronounced with stimulation than pre-operatively. Secondly, the technical feasibility depends on the possibility to register the potentials, evoked by motor cortex stimulation in the STN (so-called evoked potentials). These potentials have to be clearly identifiable in order to recognize the motor part of the STN. This is necessary as in the final study we want to compare the results of selective stimulation of the motor part of the STN with results of the classical procedure.	—

Measure

Time frame

There are two main endpoints to measure the feasibility. First, the patients burden and outcome. We will interview the patient and ask him to fill in a standardized questionnaire. Only if the burden is acceptable, we will start with the main study (average marks for each testing must be above 5 to continue with a RCT). Thereby the motor symptoms must be significantly less pronounced with stimulation than pre-operatively. Secondly, the technical feasibility depends on the possibility to register the potentials, evoked by motor cortex stimulation in the STN (so-called evoked potentials). These potentials have to be clearly identifiable in order to recognize the motor part of the STN. This is necessary as in the final study we want to compare the results of selective stimulation of the motor part of the STN with results of the classical procedure.

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Secondary

Measure	Time frame
Cognition, and in particular impulsivity, and affect, will be assessed by neuropsychological testing and a self-report questionnaire, the Positive and Negative Affect Scale (Watson et al 1988). Neuropsychological testing covers the main cognitive domains but the study parameters are related to the performance on tasks in the relevant domain of executive functioning, including word fluency, the Stroop (Lezak, 2004), a finger precuing task (Adam et al, 2002) and the Iowa Gambling Task (Bechera et al., 1994). (These are not endpoints of the feasibility trial.) Advantage of fMRI above TMS or double contrast MRI in the planning of the OR.	—

Measure

Time frame

Cognition, and in particular impulsivity, and affect, will be assessed by neuropsychological testing and a self-report questionnaire, the Positive and Negative Affect Scale (Watson et al 1988). Neuropsychological testing covers the main cognitive domains but the study parameters are related to the performance on tasks in the relevant domain of executive functioning, including word fluency, the Stroop (Lezak, 2004), a finger precuing task (Adam et al, 2002) and the Iowa Gambling Task (Bechera et al., 1994). (These are not endpoints of the feasibility trial.) Advantage of fMRI above TMS or double contrast MRI in the planning of the OR.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)