A multicenter double blind randomized crossover study comparing the impact of dorsal versus ventral subthalamic nucleus deep brain stimulation on apathy in Parkinson*s disease

A multicenter double blind randomized crossover study comparing the impact of dorsal versus ventral subthalamic nucleus deep brain stimulation on apathy in Parkinson*s disease - Apathy and DBS in Parkinson*s disease

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON50175

Enrollment

Registered

2019-09-23

Start date

2020-02-11

Completion date

Unknown

Last updated

2024-08-19

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

Conditions

a behavioral and motivational disorder Apathy

Interventions

We will randomize patients into two arms, one receiving one month of dorsal STN DBS first and then one month of regular DBS, the other arm will follow the reversed order.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients suffering from Parkinson's Disease and relying on deep brain stimulation for the treatment of this disease who develop apathy within 6 months after deep brain stimulation implantation

Exclusion criteria

Exclusion criteria: Patients with peri-operative intracerebral complications related to SNT-DBS placement (e.g. bleeding or infection) inflicting permanent changes will be excluded. Dementie

Design outcomes

Primary

Measure	Time frame
The primary outcome is the difference in SAS score change from one month of dorsal stimulation versus ventral stimulation	—

Secondary

Measure	Time frame
Secondary outcomes are MOCA: Montreal Cognitive Assessment. MDS-UPDRS-III: Movement Disorder Societys Unified Parkinsons Disease Rating Scale, motor part III. MADRS: Montgomery- Åsberg Depression Rating Scale (MADRS). PDQ-39: 39-item Parkinsons disease Questionnaire. QUIP: Parkinson's Disease Impulsive-Compulsive Disorders Questionnaire. LEDD: levodopa-equivalent daily dosage. AES-I: Apathy Evaluation Scale, a second apathy scale rated by the informal caregiver if the patient has one. SF-36: Short-Form Health Survey. Suspected Arm: Patients will be asked to choose which arm they think they were randomized for. Preferred Settings: Patients will be asked to choose which of the settings they will continue with. Although the timing for these questionnaires is the same as the visits for the patients, these questionnaires will be send by regular mail to the informed caregiver.	—

Measure

Time frame

Secondary outcomes are MOCA: Montreal Cognitive Assessment. MDS-UPDRS-III: Movement Disorder Society*s Unified Parkinson*s Disease Rating Scale, motor part III. MADRS: Montgomery- Åsberg Depression Rating Scale (MADRS). PDQ-39: 39-item Parkinson*s disease Questionnaire. QUIP: Parkinson's Disease Impulsive-Compulsive Disorders Questionnaire. LEDD: levodopa-equivalent daily dosage. AES-I: Apathy Evaluation Scale, a second apathy scale rated by the informal caregiver if the patient has one. SF-36: Short-Form Health Survey. Suspected Arm: Patients will be asked to choose which arm they think they were randomized for. Preferred Settings: Patients will be asked to choose which of the settings they will continue with. *Although the timing for these questionnaires is the same as the visits for the patients, these questionnaires will be send by regular mail to the informed caregiver.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)