Apathy and DBS 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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON22692

Enrollment

Registered

2020-01-10

Start date

2020-01-10

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

Interventions

26 PD patients will be randomly assigned to one of two arms. Arm-A will undergo 1 month of dorsal stimulation (intervention) followed by 1 month of regular stimulation (control). Arm-B will undergo 1

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients suffering from Parkinson’s disease. 2. At least three months of STN DBS surgery. 3. Apathy — i.e., a 14 or more points on the SAS in PD patients.

Exclusion criteria

Exclusion criteria: 1. Peri-operative intracerebral complications related to SNT-DBS placement (e.g., bleeding or infection) inflicting permanent changes. 2. Dementia (MOCA score of 25 or less) 3. Patients who are not sufficient in the Dutch language 4. Patients who are already stimulated on the most dorsal contact point on both electrodes 4. Legally incompetent adults 5. No signed informed consent

Design outcomes

Primary

Measure	Time frame
The primary outcome is the comparison of the SAS score following one month of DBS on the original contact and the SAS score following one month of DBS on the more dorsal contact.	—

Secondary

Measure	Time frame
Secondary outcomes are symptom changes on the Movement Disorders Society-Unified Parkinson’s Disease Rating Scale motor part III (MDS-UPDRS-III), Montgomery- Åsberg Depression Rating Scale (MADRS), 39-item Parkinson’s disease Questionnaire (PDQ-39) Parkinson's Disease Impulsive-Compulsive Disorders Questionnaire (QUIP), changes in levodopa-equivalent daily dosage (LEDD), apathy rated by the caregiver (AES-I), and burden and quality of life of the caregiver (SF-36). Imaging data available from standard clinical care (pre-operative structural and diffusion-weighted MRI scans and post-operative CT-scan) will be used to determine the locations and white matter connections of the experimental and original stimulation contact, and to correlate this contact-specific neuroanatomical information with apathy scores and effectiveness of the intervention.	—

Measure

Time frame

Secondary outcomes are symptom changes on the Movement Disorders Society-Unified Parkinson’s Disease Rating Scale motor part III (MDS-UPDRS-III), Montgomery- Åsberg Depression Rating Scale (MADRS), 39-item Parkinson’s disease Questionnaire (PDQ-39) Parkinson's Disease Impulsive-Compulsive Disorders Questionnaire (QUIP), changes in levodopa-equivalent daily dosage (LEDD), apathy rated by the caregiver (AES-I), and burden and quality of life of the caregiver (SF-36). Imaging data available from standard clinical care (pre-operative structural and diffusion-weighted MRI scans and post-operative CT-scan) will be used to determine the locations and white matter connections of the experimental and original stimulation contact, and to correlate this contact-specific neuroanatomical information with apathy scores and effectiveness of the intervention.

—

Contacts

Public ContactThomas Zoon

Amsterdam UMC

t.j.zoon@amsterdamumc.nl0208913651

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)