Apraxia DBS: Apraxia in Parkinson's Disease Patients With Deep Brain Stimulation

Sponsor
University of Florida (Other)
Overall Status
Recruiting
CT.gov ID
NCT04725773
Collaborator
(none)
60
1
31.9
1.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Deep brain stimulation effect on apraxia

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 Design

Study Type:
Observational
Anticipated Enrollment :
60 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
Apraxia in Parkinson's Disease Patients With Deep Brain Stimulation
Actual Study Start Date :
Jun 1, 2021
Anticipated Primary Completion Date :
Jan 28, 2024
Anticipated Study Completion Date :
Jan 28, 2024

Arms and Interventions

Arm Intervention/Treatment
PD DBS

Patients with Parkinson's disease and deep brain stimulation

Device: Deep brain stimulation effect on apraxia
We will evaluate the effect of DBS on apraxia

Outcome Measures

Primary Outcome Measures

  1. 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" Bring thumb extended on forehead, other fingers point upwards 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" Drink from a glass Smoke a cigarette Use a hammer Use scissors Use a stamp to postmark Pantomime General instruction: "Now gestures are asked. Listen very carefully and perform them as precisely as possible" "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"

  2. 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.

  3. 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 coin rotation test. Coin rotation test The subject is asked to take a coin and rotate it 180 degrees between their thumb, index and middle fingers as fast as they can twenty times. They will rotate the coin so that the thumb pushes the bottom part of the coin up and away from themselves. The task will be repeated 3 times for each hand. Each task is timed.

  4. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 UF Health at the University of Florida Gainesville Florida United States 32608

Sponsors and Collaborators

  • University of Florida

Investigators

  • Principal Investigator: Bhavana Patel, DO, University of Florida

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
University of Florida
ClinicalTrials.gov Identifier:
NCT04725773
Other Study ID Numbers:
  • IRB202001999
First Posted:
Jan 27, 2021
Last Update Posted:
Jun 30, 2022
Last Verified:
Jun 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 30, 2022