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

Not Applicable

Terminated

• Conditions: Parkinson Disease
• Interventions: Procedure: Personalized DBS adjustments

• Registration Number: NCT03800108
• Lead Sponsor: Darlene Floden

Brief Summary

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).

Detailed 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.

Study Timeline

• Study First Submitted: 2018-05-23
• Study Start: 2018-05-30
• Study First Submitted QC: 2019-01-10
• Study First Posted: 2019-01-11
• Primary Completion: 2020-01-14
• Study Completion: 2020-01-14
• Results First Submitted: 2025-01-02
• Status Verified: 2025-02
• Results First Submitted QC: 2025-02-03
• Last Update Submitted: 2025-02-03
• Results First Posted: 2025-02-05
• Last Update Posted: 2025-02-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Personalized DBS adjustments	Personalized DBS adjustments	Individualized stimulation adjustments based on pre- and post- DBS implantation MRIs

Primary Outcome Measures

Name	Time	Method
Reaction Time	30-60 minutes after stimulation adjustment	Subjects will complete one or more measures of cognitive processing requiring speeded responses to stimuli. Changes in reaction time will be compared to 'off stimulation'
Verbal Fluency	30-60 minutes after stimulation adjustment	Change in the number words that patients generate to letter or semantic category cues will be compared to 'off stimulation'
Finger Tapping Speed	30-60 minutes after stimulation adjustment	Change in upper extremity speed (# of taps in 10 seconds) will be compared to 'off stimulation'

Trial Locations

Locations (1)

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States