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

Parkinson Disease Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03800108
• Other study ID #: 17-1350
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 30, 2018
• Est. completion date: September 30, 2024

Study information

• Verified date: August 2023
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 15
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Procedure:
• Personalized DBS adjustments
Individualized stimulation adjustments based on pre- and post- DBS implantation MRIs

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Darlene Floden

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reaction time	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'	30-60 minutes after stimulation adjustment
Primary	Verbal Fluency	Change in the number words that patients generate to letter or semantic category cues will be compared to 'off stimulation'	30-60 minutes after stimulation adjustment
Primary	Finger tapping speed	Change in upper extremity speed (# of taps in 10 seconds) will be compared to 'off stimulation'	30-60 minutes after stimulation adjustment