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TerminatedNCT04725773Apraxia DBSUpdated Jul 16, 2025

Apraxia in Parkinson's Disease Patients With Deep Brain Stimulation

An observational study in Deep Brain Stimulation, Parkinson Disease and Apraxia, Motor, sponsored by University of Florida. Terminated at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-07-16.

Sponsored by University of Florida · Observational

Why this study was terminated
Insufficient Enrollment
Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
2
Ages
18 Years to 80 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Deep Brain Stimulation
  • Parkinson Disease
  • Apraxia, Motor
03

In context

Parkinson Disease

4,573 studies on the registry are indexed under Parkinson Disease; 1,086 are open to participants now.

This study's enrollment of 2 is below the median of 96 across 1,085 observational studies indexed under Parkinson Disease.

Browse Parkinson Disease studies →

Lead sponsor

University of Florida is the lead sponsor of 1,287 studies on the registry; 199 are open to participants now.

Of its 180 completed or terminated interventional studies of FDA-regulated products, 143 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
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Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
2 participants (actual)
Patient registry
No

Groups and cohorts

  • PD DBS

    Patients with Parkinson's disease and deep brain stimulation

    Device: Deep brain stimulation effect on apraxia

Interventions

  • DeviceDeep brain stimulation effect on apraxia

    We will evaluate the effect of DBS on apraxia

06

What researchers measure

Primary outcomes

  1. 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"

    Time frame: Up to 1 hour

  2. 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.

    Time frame: Up to 1 hour

  3. 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.

    Time frame: Up to 30 minutes

  4. 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.

    Time frame: Up to 30 minutes

07

Study locations

1 site
  • UF Health at the University of Florida
    Gainesville, Florida 32608, United States
08

References and documents

Publications

  • Agostoni E, Coletti A, Orlando G, Tredici G. Apraxia in deep cerebral lesions. J Neurol Neurosurg Psychiatry. 1983 Sep;46(9):804-8. doi: 10.1136/jnnp.46.9.804. PubMed 6619888 ↗
  • Basso A, Luzzatti C, Spinnler H. Is ideomotor apraxia the outcome of damage to well-defined regions of the left hemisphere? Neuropsychological study of CAT correlation. J Neurol Neurosurg Psychiatry. 1980 Feb;43(2):118-26. doi: 10.1136/jnnp.43.2.118. PubMed 7359149 ↗
  • Bolognini N, Convento S, Banco E, Mattioli F, Tesio L, Vallar G. Improving ideomotor limb apraxia by electrical stimulation of the left posterior parietal cortex. Brain. 2015 Feb;138(Pt 2):428-39. doi: 10.1093/brain/awu343. Epub 2014 Dec 5. PubMed 25481002 ↗
  • Cavaco S, Anderson SW, Correia M, Magalhaes M, Pereira C, Tuna A, Taipa R, Pinto P, Pinto C, Cruz R, Lima AB, Castro-Caldas A, da Silva AM, Damasio H. Task-specific contribution of the human striatum to perceptual-motor skill learning. J Clin Exp Neuropsychol. 2011 Jan;33(1):51-62. doi: 10.1080/13803395.2010.493144. Epub 2010 Jul 5. PubMed 20603739 ↗
  • Falchook AD, Decio D, Williamson JB, Okun MS, Malaty IA, Rodriguez RL, Heilman KM. Alternate but do not swim: a test for executive motor dysfunction in Parkinson disease. J Int Neuropsychol Soc. 2011 Jul;17(4):702-8. doi: 10.1017/S1355617711000609. PubMed 22882811 ↗
  • Foki T, Vanbellingen T, Lungu C, Pirker W, Bohlhalter S, Nyffeler T, Kraemmer J, Haubenberger D, Fischmeister FP, Auff E, Hallett M, Beisteiner R. Limb-kinetic apraxia affects activities of daily living in Parkinson's disease: a multi-center study. Eur J Neurol. 2016 Aug;23(8):1301-7. doi: 10.1111/ene.13021. Epub 2016 May 1. PubMed 27132653 ↗
  • Gebhardt A, Vanbellingen T, Baronti F, Kersten B, Bohlhalter S. Poor dopaminergic response of impaired dexterity in Parkinson's disease: Bradykinesia or limb kinetic apraxia? Mov Disord. 2008 Sep 15;23(12):1701-6. doi: 10.1002/mds.22199. PubMed 18649388 ↗
  • Heilman KM, Rothi LJ, Valenstein E. Two forms of ideomotor apraxia. Neurology. 1982 Apr;32(4):342-6. doi: 10.1212/wnl.32.4.342. PubMed 7199656 ↗
  • 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. PubMed 23075179 ↗
  • Quencer K, Okun MS, Crucian G, Fernandez HH, Skidmore F, Heilman KM. Limb-kinetic apraxia in Parkinson disease. Neurology. 2007 Jan 9;68(2):150-1. doi: 10.1212/01.wnl.0000250331.35912.a5. Epub 2006 Dec 6. PubMed 17151340 ↗
  • 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. PubMed 22177625 ↗
  • 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. PubMed 30363441 ↗
  • 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. PubMed 3729758 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 16, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04725773
Responsible party
Sponsor
First posted
Jan 27, 2021
Start date
Jun 1, 2021
Primary completion
Jan 28, 2024
Completion
Jan 28, 2024
Last update
Jul 16, 2025

Study contacts

Bhavana Patel, DO
principal investigator · University of Florida

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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