search
Back to results

Motor Training in PD

Primary Purpose

Parkinson Disease

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Adapted Tango Dancing
Behavioral Control (BC) Condition
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Parkinson Disease focused on measuring Magnetic Resonance Imaging, Neurology, Neurosciences, Physical Medicine, Parkinson Disease, Rehabilitation

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Atlanta VA Medical and Rehab Center, Decatur, GA

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Active Comparator

No Intervention

Arm Label

Internal guidance training (IG)

Externally guided training (EG)

Behavioral Control (BC)

Normal Control (NC)

Arm Description

Adapted tango dancing is a sophisticated, yet accessible system of tactile communication that conveys motor intentions and goals between a leader and follower. Those in IG training will choose direction, timing and amplitude of each successive step, and will communicate this information to their partner through moving their frame and center of mass.

Those in EG will learn to attend to sensory cues for movement direction, timing and amplitude of steps, communicated from their partner to them via the frame and center of mass. The 'follower' will wait to receive the movement cue before moving.

BC participants will attend 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. Participants in this training will be instructed not to change their habitual exercise routines. After completing health education, participants will be assigned to an IG or EG training class but will not undergo evaluations.

Age-matched controls without Parkinson's disease will come in for a single assessment including MRI.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
May 21, 2015
Last Updated
February 23, 2023
Sponsor
VA Office of Research and Development
search

1. Study Identification

Unique Protocol Identification Number
NCT02457832
Brief Title
Motor Training in PD
Official Title
Optimizing Motor Training in Parkinson Disease Through Neural Mechanisms (NEURODEGEN)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 3, 2014 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Magnetic Resonance Imaging, Neurology, Neurosciences, Physical Medicine, Parkinson Disease, Rehabilitation

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
111 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Internal guidance training (IG)
Arm Type
Experimental
Arm Description
Adapted tango dancing is a sophisticated, yet accessible system of tactile communication that conveys motor intentions and goals between a leader and follower. Those in IG training will choose direction, timing and amplitude of each successive step, and will communicate this information to their partner through moving their frame and center of mass.
Arm Title
Externally guided training (EG)
Arm Type
Experimental
Arm Description
Those in EG will learn to attend to sensory cues for movement direction, timing and amplitude of steps, communicated from their partner to them via the frame and center of mass. The 'follower' will wait to receive the movement cue before moving.
Arm Title
Behavioral Control (BC)
Arm Type
Active Comparator
Arm Description
BC participants will attend 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. Participants in this training will be instructed not to change their habitual exercise routines. After completing health education, participants will be assigned to an IG or EG training class but will not undergo evaluations.
Arm Title
Normal Control (NC)
Arm Type
No Intervention
Arm Description
Age-matched controls without Parkinson's disease will come in for a single assessment including MRI.
Intervention Type
Behavioral
Intervention Name(s)
Adapted Tango Dancing
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Behavioral Control (BC) Condition
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percent signal change
Description
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.
Time Frame
12 weeks
Title
Connectivity strength
Description
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.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Madeleine E. Hackney, PhD
Organizational Affiliation
Atlanta VA Medical and Rehab Center, Decatur, GA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Atlanta VA Medical and Rehab Center, Decatur, GA
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033-4004
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31834219
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.
Results Reference
derived

Learn more about this trial

Motor Training in PD

We'll reach out to this number within 24 hrs