Stimulation Parameters and Non-motor Symptoms in PD Treated With DBS (FREQUENCY)

Darlene Floden

Status: Terminated

Conditions: Parkinson Disease

Treatments: Procedure: Personalized DBS adjustments

Study type: Interventional

Funder types: Other

Identifiers

NCT03800108

17-1350

Details and patient eligibility

About

This study evaluates the role of subthalamic nucleus (STN) stimulation location and frequency on a range of cognitive processes in Parkinson's patients who have undergone Deep Brain Stimulation (DBS).

Full description

Pre- and post- DBS implantation brain scans will be reviewed by the study team to see if patients' DBS settings can be personalized. If so, study subjects will undergo adjustments to their DBS settings and be asked to perform cognitive tests. Some patients will be asked to come back for a second visit for brain scans.

Enrollment: 5 patients

Sex: All

Ages: 40 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Between 40 and 70 years of age,
2. Ability to provide informed consent,
3. Clinical diagnosis of idiopathic Parkinson disease (PD) by a movement disorders neurologist,
4. Disease duration of at least 4 years,
5. Treated with bilateral STN DBS for at least 3 months prior to study enrollment.

Exclusion criteria

1. History of prior neurosurgical intervention for PD (e.g., DBS, thalamotomy, pallidotomy)

2. History of other central nervous system disease (excluding migraine),

3. Presence of active psychiatric symptoms meeting Diagnostic and Statistical Manual of Mental Disorders-4th Edition (DSM-IV) criteria for Axis-I disorder on formal psychiatric evaluation, with the exception of mild depression (Beck Depression Inventory-2 score below 19),

4. Cognitive impairment meeting Diagnostic and Statistical Manual of Mental Disorders-4th Edition (DSM-IV) criteria for dementia on formal neuropsychological evaluation,

5. Current alcohol or substance abuse,

6. Lack of fluency in English which would invalidate cognitive testing,

7. Hearing or visual impairment precluding cognitive testing.

   Exclusion criteria for Day 2 procedures:

8. Inability to safely undergo MRI procedure (i.e., metal objects like prostheses, pacemakers)

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

Personalized DBS adjustments

Other group

Description:

Individualized stimulation adjustments based on pre- and post- DBS implantation MRIs

Treatment:

Procedure: Personalized DBS adjustments