Apraxia in Parkinson's Disease Patients With Deep Brain Stimulation

NCT ID: NCT04725773

Last Updated: 2025-07-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

2 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-01

Study Completion Date

2024-01-28

Brief Summary

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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

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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.

Conditions

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Deep Brain Stimulation Parkinson Disease Apraxia, Motor

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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PD DBS

Patients with Parkinson's disease and deep brain stimulation

Deep brain stimulation effect on apraxia

Intervention Type DEVICE

We will evaluate the effect of DBS on apraxia

Interventions

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Deep brain stimulation effect on apraxia

We will evaluate the effect of DBS on apraxia

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bhavana Patel, DO

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

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UF Health at the University of Florida

Gainesville, Florida, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 6619888 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 7359149 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25481002 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20603739 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22882811 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27132653 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18649388 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 7199656 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23075179 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17151340 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22177625 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30363441 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 3729758 (View on PubMed)

Other Identifiers

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IRB202001999

Identifier Type: -

Identifier Source: org_study_id

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