Clinical trial NCT02457832: Motor Training in PD
Official title: Optimizing Motor Training in Parkinson Disease Through Neural Mechanisms (NEURODEGEN)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: Magnetic Resonance Imaging
Neurology
Neurosciences
Physical Medicine
Parkinson Disease
Rehabilitation
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2015-05-29
Enrollment: 87
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this research study is to learn more about brain activity when individuals with and without Parkinson disease (PD) move their lower limbs. The investigators also want to see if and how two different types of partnered dance affect brain activity in individuals with and without PD. Testing will take place at the Atlanta VA Medical Center and at Emory University. The investigators expect to enroll about 140 people for this study over a five-year period.

Detailed description: Persons with Parkinson's disease (PD) have impaired mobility, which adversely affects their quality of life. The effectiveness of adapted tango dance, in which participants both lead (internally guide: IG) and follow (externally guide: EG) movement has been shown. To improve outcomes in those with PD, the underlying brain mechanisms for both motor impairments and improvement must be studied. IG and EG movements have distinct brain activity patterns. Individuals with PD have trouble with IG movement but this problem is helped by strategies used while "leading." During "following", participants with PD can use many external cues, which helps movement in PD, because EG tasks bypass the basal ganglia, the part of the brain affected by PD. In older persons with PD, the investigators aim to:

* determine brain activation patterns during IG and EG foot movement.
* look into effects of IG and EG training on brain activation along with mobility improvements.

The investigators will begin with a functional Magnetic Resonance Imaging test in a scanner. The investigators will look at brain area correlates of a clinically-used foot-tapping task, during IG and EG conditions in older persons with and without PD. Then, the investigators will assess the relative effectiveness of IG versus EG training during an adapted tango class, compared to a group that participates in health education, for improved mobility and foot tapping. Participants with PD will be assessed for disease severity. They will receive tests of outcome measures while "OFF" and "ON" PD-specific medications at the following time points:

* 1 week before training
* 1 week after training
* 1 month after training Participants must attend 20 lessons of IG or EG adapted tango in 12 weeks, taught by an experienced instructor. In the functional MRI (fMRI) scanner, the investigators will assess participants for improved foot tapping after training. The investigators will also look at changes in activation in specific brain circuits along with training effects upon mobility.

The long-term goal is to improve motor training as much as possible for persons with PD by understanding foot movement brain circuitry in PD as well as brain changes in circuitry through which training is effective. This work proposes to illumine information about brain function that is very important to continued progress in rehabilitative care of persons with PD.

Eligibility criteria: Inclusion Criteria:

* Age 40 - 70 years
* Willingness to spend 1-h in a scanner
* Able to walk with or without an assistive device 10 feet
* Best corrected/aided acuity better than 20/70 in the better eye
* Absence of dementia or vascular cognitive impairment
* Absence of primary memory deficits

Exclusion Criteria:

* Deep brain stimulator implants, Metallic implants, fragments, or pacemakers
* Montreal Cognitive Assessment (MocA) score \< 24
* Pure-tone threshold sensitivity \> 40 dB
* Peripheral neuropathy
* Untreated Major Depression
* History of stroke, or traumatic brain injury

Primary outcomes:
measure: Percent Signal Change
timeFrame: 12 weeks
measure: Connectivity Strength
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Decatur
country: United States
facility: Atlanta VA Medical and Rehab Center, Decatur, GA
state: Georgia
Study officials:
affiliation: Atlanta VA Medical and Rehab Center, Decatur, GA
name: Madeleine E. Hackney, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Prime M, McKay JL, Bay AA, Hart AR, Kim C, Abraham A, Hackney ME. Differentiating Parkinson Disease Subtypes Using Clinical Balance Measures. J Neurol Phys Ther. 2020 Jan;44(1):34-41. doi: 10.1097/NPT.0000000000000297.