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

University of Florida

Status: Enrolling

Conditions: Parkinson Disease; Deep Brain Stimulation; Apraxia, Motor

Treatments: Device: Deep brain stimulation effect on apraxia

Study type: Observational

Funder types: Other

Identifiers

NCT04725773

IRB202001999

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

60 participants in 1 patient group

PD DBS

Description:

Patients with Parkinson's disease and deep brain stimulation

Treatment:

Device: Deep brain stimulation effect on apraxia