Motor Training in PD

Parkinson Disease Clinical Trial

Official title:

Optimizing Motor Training in Parkinson Disease Through Neural Mechanisms (NEURODEGEN)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02457832
• Other study ID #: N0870-W
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 3, 2014
• Est. completion date: December 31, 2023

Study information

• Verified date: February 2023
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 111
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Behavioral:
• Adapted Tango Dancing
Composed of simple steps, tango involves frequent movement initiation and cessation, multi-directional perturbations and varied rhythms. Participants focus on trunk control and stepping strategies, coordination, somatosensory awareness, attention to partner, path of movement, and aesthetics. Sessions will begin with a typical dance class warm-up consisting of breathing, limbering and postural alignment to upbeat music. Novel step elements will be introduced every class period. Those with PD will partner with an individual without PD. After novel step introduction, the instructor will present rhythmic training, which is indispensable to partnered dancing. Participants will learn 'typical' rhythms from tango and Latin dances, based upon the system of quicks (Q) and slows (S), ubiquitously used in ballroom dance training to understand the temporal relationship of movement to music.
• Behavioral Control (BC) Condition
Group health education sessions adapted to the needs of individuals with PD, about pharmacological management, nutrition, sleep disorders, cognitive deficits, bereavement coping, mobility, balance and home safety.

Locations

Country	Name	City	State
United States	Atlanta VA Medical and Rehab Center, Decatur, GA	Decatur	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent signal change	For the IG and EG tasks for the MRI, the investigators want to determine and distinguish circuits involved in IG and EG foot-tapping networks in participants with and without PD.	12 weeks
Primary	Connectivity strength	Changes in average connectivity strength across striatal-thalamo-cortical (STC) and cerebello-thalamo-cortical (CTC) circuits, as measured by average cross correlation coefficient between the seed regions of the circuits.	12 weeks