Apraxia in Parkinson's Disease Patients With Deep Brain Stimulation

NCT04725773 | Terminated FDA Device

• 1 other identifier: IRB202001999
• Study Type: observational
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Deep Brain Stimulation; Parkinson Disease; Apraxia, Motor

Outcome Measures

Primary Outcomes (4)

• Evaluate for the presence or absence of ideomotor apraxia in PD patients

  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

  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

  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

  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

Study Arms (1)

PD DBS

Patients with Parkinson's disease and deep brain stimulation

Device: Deep brain stimulation effect on apraxia

Interventions

Deep brain stimulation effect on apraxia DEVICE

We will evaluate the effect of DBS on apraxia

PD DBS

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

UF Health at the University of Florida

Gainesville, Florida, 32608, United States

Location

Related Publications (13)

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  PMID: 20603739 BACKGROUND

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  PMID: 22882811 BACKGROUND

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• Okun MS. Deep-brain stimulation for Parkinson's disease. N Engl J Med. 2012 Oct 18;367(16):1529-38. doi: 10.1056/NEJMct1208070. No abstract available.

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• Vanbellingen T, Lungu C, Lopez G, Baronti F, Muri R, Hallett M, Bohlhalter S. Short and valid assessment of apraxia in Parkinson's disease. Parkinsonism Relat Disord. 2012 May;18(4):348-50. doi: 10.1016/j.parkreldis.2011.11.023. Epub 2011 Dec 16.

  PMID: 22177625 BACKGROUND

• Vanbellingen T, Hofmanner D, Kubel S, Bohlhalter S. Limb Kinetic Apraxia Is an Independent Predictor for Quality of Life in Parkinson's Disease. Mov Disord Clin Pract. 2018 Jan 25;5(2):156-159. doi: 10.1002/mdc3.12572. eCollection 2018 Mar-Apr.

  PMID: 30363441 BACKGROUND

• Watson RT, Fleet WS, Gonzalez-Rothi L, Heilman KM. Apraxia and the supplementary motor area. Arch Neurol. 1986 Aug;43(8):787-92. doi: 10.1001/archneur.1986.00520080035016.

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MeSH Terms

Conditions

Parkinson Disease; Apraxias

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Psychomotor Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Bhavana Patel, DO

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2021
• First Posted: January 27, 2021
• Study Start: June 1, 2021
• Primary Completion: January 28, 2024
• Study Completion: January 28, 2024
• Last Updated: July 16, 2025

Record last verified: 2025-07

Locations

US (1)