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

August 1, 2023 updated by: University of Florida
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with Parkinson's disease who underwent deep brain stimulation for help of their motor symptoms.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate for the presence or absence of ideomotor apraxia in PD patients
Time Frame: 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"
Up to 1 hour
Evaluate for the presence or absence of ideational apraxia in PD patients
Time Frame: 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.
Up to 1 hour
Evaluate for the presence or absence of limb-kinetic apraxia in PD patients
Time Frame: 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.
Up to 30 minutes
Evaluate for the presence or absence of limb-kinetic apraxia in PD patients
Time Frame: 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.
Up to 30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Florida

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2021

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

January 1, 2025

Study Registration Dates

First Submitted

January 13, 2021

First Submitted That Met QC Criteria

January 21, 2021

First Posted (Actual)

January 27, 2021

Study Record Updates

Last Update Posted (Actual)

August 2, 2023

Last Update Submitted That Met QC Criteria

August 1, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB202001999

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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