Apraxia in Parkinson's Disease Patients With Deep Brain Stimulation

Recruiting

• Conditions: Parkinson Disease; Apraxia, Motor; Deep Brain Stimulation
• Interventions: Device: Deep brain stimulation effect on apraxia

• Registration Number: NCT04725773
• Lead Sponsor: University of Florida

Brief Summary

Deep brain stimulation (DBS) of the subthalamic nucleus or globus pallidus internus can improve motor symptoms Parkinson's disease (PD). However, it is not known whether DBS can help reduce the signs and symptoms of the limb-kinetic, ideomotor or ideational apraxia associated with PD or if apraxia can exist as a stimulation induced side effect from DBS therapy. In this study, we look to conduct a pilot study to examine the feasibility of characterizing the prevalence of apraxia in PD patients with chronic, stable DBS.

Detailed Description

This will be a pilot study designed to assess the safety and feasibility of an apraxia testing protocol in chronically implanted PD DBS patients. We hypothesize that apraxia testing in the DBS ON and OFF states will be a safe and well-tolerated testing protocol. We also hypothesize that DBS will affect the severity of limb-kinetic, ideomotor and ideational apraxia in PD patients. This will set the foundation for larger prospective trials to further characterize apraxia in relation to DBS and whether or not DBS programming can modulate this phenomenon.

In this study, we will recruit 60 PD patients with chronic, stable DBS of either the subthalamic nucleus (STN) or globus pallidus interna (GPi). Both unilateral and bilateral DBS patients are eligible for this study. For this study, "chronic, stable DBS" will be defined as patients who have had at least 6 months of optimization programming at the University of Florida. The subjects will be recruited to the Fixel clinic for a 1-day study visit in the medication ON state. The patients will undergo testing for limb-kinetic, ideomotor and ideational apraxia of both upper extremities in the DBS ON state at home therapeutic settings.

Study Timeline

• Study First Submitted: 2021-01-13
• Study First Submitted QC: 2021-01-21
• Study First Posted: 2021-01-27
• Study Start: 2021-06-01
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-01
• Last Update Posted: 2023-08-02
• Primary Completion: 2025-01-01
• Study Completion: 2025-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Patients with PD as defined by the UK Brain Bank Criteria
2. Male or female, ages 18 to 80 years old
3. Chronically implanted DBS of either the STN or GPi for a minimum of 6 months

Exclusion Criteria

1. Other neurological diagnoses (e.g. Alzheimer's disease, atypical parkinsonism, stroke)
2. History of previous neurosurgical intervention that was not DBS
3. Patients with DBS of targets other than the STN or GPi, or leads in both targets
4. Patients in whom there is poor manual dexterity for a reason other than PD (e.g. orthopedic injury, amputation)
5. Patients with a diagnosis of PD dementia

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PD DBS	Deep brain stimulation effect on apraxia	Patients with Parkinson's disease and deep brain stimulation

Primary Outcome Measures

Name	Time	Method
Evaluate for the presence or absence of limb-kinetic apraxia in PD patients	Up to 30 minutes	Evaluate the effect of DBS on limb-kinetic apraxia in PD patients. We will assess this via the grooved pegboard test.; Grooved Pegboard The Grooved Pegboard is a manipulative dexterity test. This unit consists of 25 holes with randomly positioned slots. Pegs, which have a key along one side, must be rotated to match the hole before the can be inserted. The pegboard is placed in mid-line with the subject so that the board is at the edge of the table and peg tray immediately above the board.; All the pegs are the same. They have a groove, that is, a round side and a square side and so do the holes in the boards. What you must do is match the groove of the peg with the groove of the board and put these pegs into the holes like this.
Evaluate for the presence or absence of ideational apraxia in PD patients	Up to 1 hour	Evaluate the effect of DBS on Ideational apraxia in PD patients. We will assess this via the picture sequencing test. The outcome will be a binary (yes/no) result based on the testing.; In this test, there is an activity that is represented by 4 black and white photographs: 3 of the photographs show a set of objects, tools, and actions needed to complete a step of the activity, and 1 photograph shows the completed task. The 4 photographs are arranged randomly, 1 per quadrant on an 8 1/2"×11" sheet of white paper. Participants are required to touch each picture in the correct sequence needed to complete each activity.
Evaluate for the presence or absence of ideomotor apraxia in PD patients	Up to 1 hour	Evaluate the effect of DBS on ideomotor apraxia in PD patients. We will assess the TULIA screening assessment: General instruction: "Seven gestures are demonstrated in a mirror fashion, imitate them as precisely as possible"; 1. Bring thumb extended on forehead, other fingers point upwards; 2. Wipe dust from shoulder; Additional instruction: "For the next five gestures, imagine holding a tool or an object in hand, don't use your fingers as a tool"; 3. Drink from a glass; 4. Smoke a cigarette; 5. Use a hammer; 6. Use scissors; 7. Use a stamp to postmark; Pantomime General instruction: "Now gestures are asked. Listen very carefully and perform them as precisely as possible"; 8. "Show as if someone is crazy" 9 . "Make a threatening sign"; Additional instruction: "Again, imagine holding a tool or an object in hand, don't use the fingers"; 10. "Brush your teeth" 11. "Comb your hair" 12. "Use a screwdriver"

Trial Locations

Locations (1)

UF Health at the University of Florida; 🇺🇸 Gainesville, Florida, United States