ClinicalTrials.gov
ClinicalTrials.gov Menu

CONTROL Walking Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03790657
Recruitment Status : Not yet recruiting
First Posted : December 31, 2018
Last Update Posted : January 3, 2019
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:
Older adults often experience substantial deficits in walking ability, especially for walking tasks that are more complex such as obstacle crossing. This is due in part to changes in the brain that make performance of physical and cognitive tasks more difficult. Rehabilitation can help to improve walking ability, but effective rehabilitation is time consuming and expensive. New approaches are needed to improve the efficiency of rehabilitation so that gains in walking ability are widely attainable. A promising strategy is to focus on enhancing motor learning, which is defined as improved ability to perform a motor task due to practice or experience. The investigators will investigate the use of non-invasive brain stimulation to increase motor learning and retention of the newly learned walking skills. The investigators will also use neuroimaging to assess brain characteristics that explain how motor learning works. The knowledge gained from this study is expected to contribute to better understanding of mechanistic targets and intervention approaches to improve rehabilitation of walking.

Condition or disease Intervention/treatment Phase
Aging Behavioral: practice of a complex walking task Device: Dosage A: transcranial direct current stimulation (tDCS) Device: Dosage B: transcranial direct current stimulation (tDCS) Early Phase 1

Detailed Description:

Aging often leads to substantial declines in walking function, especially for walking tasks that are more complex such as obstacle crossing. This is due in part to a lack of continued practice of complex walking (sedentary lifestyle) combined with age-related deficits of brain structure and the integrity of brain networks. Neurorehabilitation can contribute to recovery of lost walking function in older adults, but major and persistent improvements are elusive. A cornerstone of neurorehabilitation is motor learning, defined as an enduring change in the ability to perform a motor task due to practice or experience. Unfortunately, in most clinical settings, the time and cost demands of delivering a sufficiently intensive motor learning intervention is not feasible. There is a need for research to develop strategies for enhancing motor learning of walking ("locomotor learning") in order to improve the effectiveness of neurorehabilitation.

The objective of this study is to use non-invasive brain stimulation to augment locomotor learning and to investigate brain networks that are responsible for locomotor learning in mobility-compromised older adults. The investigators have shown that frontal brain regions, particularly prefrontal cortex, are crucial to control of complex walking tasks. The investigators' neuroimaging and neuromodulation studies also show that prefrontal cortex structure and network connectivity are important for acquisition and consolidation of new motor skills. However, a major gap exists regarding learning of walking tasks. The proposed study is designed to address this gap. The investigators' pilot data from older adults shows that prefrontal transcranial direct current stimulation (tDCS) administered during learning of a complex obstacle walking task contributes to multi-day retention of task performance. In the proposed study the investigators will build upon this pilot work by conducting a full scale trial that also investigates mechanisms related to brain structure, functional activity, and network connectivity. The investigators will address the following specific aims:

Specific Aim 1: Determine the extent to which prefrontal tDCS augments the effect of task practice for retention of performance on a complex obstacle walking task.

Specific Aim 2: Determine the extent to which retention of performance is associated with individual differences in baseline and practice-induced changes in brain measures (including gray matter volume and brain network segregation).

Specific Aim 3: Investigate the extent to which tDCS modifies resting state network segregation.

The investigators anticipate that prefrontal tDCS will augment retention of locomotor learning, and that the data will provide the first evidence of specific brain mechanisms responsible for locomotor learning/retention in older adults with mobility deficits. This new knowledge will provide a clinically feasible intervention approach as well as reveal mechanistic targets for future interventions to enhance locomotor learning and retention.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will randomized to one of two dosages of transcranial direct current stimulation (tDCS): Dosage A or Dosage B
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Participants will not be told which dosage group they are assigned to. Outcomes Assessors will not be told which dosage group the participant was randomized to.
Primary Purpose: Basic Science
Official Title: Cerebral Networks of Locomotor Learning and Retention in Older Adults
Estimated Study Start Date : May 1, 2019
Estimated Primary Completion Date : March 31, 2023
Estimated Study Completion Date : March 31, 2023

Arm Intervention/treatment
Experimental: tDCS Dosage A
mild electrical stimulation (Dosage level "A") delivered to the frontal region of the brain during practice of a complex walking task
Behavioral: practice of a complex walking task
walking over obstacles

Device: Dosage A: transcranial direct current stimulation (tDCS)
mild electrical stimulation delivered to the frontal region of the brain

Experimental: tDCS Dosage B
mild electrical stimulation (Dosage level "B") delivered to the frontal region of the brain during practice of a complex walking task
Behavioral: practice of a complex walking task
walking over obstacles

Device: Dosage B: transcranial direct current stimulation (tDCS)
mild electrical stimulation delivered to the frontal region of the brain




Primary Outcome Measures :
  1. Walking speed change from baseline [ Time Frame: Measured at follow up visit (approximately three weeks after baseline) ]
    Change in the fastest safe walking speed over a complex walking course


Secondary Outcome Measures :
  1. Prefrontal cortex gray matter volume change from baseline [ Time Frame: Measured at follow up visit (approximately three weeks after baseline) ]
    Change in the volume of gray matter in the prefrontal cortex, as measured by MRI

  2. Brain resting state network segregation [ Time Frame: Measured at follow up visit (approximately three weeks after baseline) ]
    Change in resting state network segregation.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • age 65 years or older
  • preferred 10m walking speed < 1.1 m/s
  • self-report of "some difficulty with walking tasks, such as becoming tired when walking a quarter mile, or when climbing two flights of stairs, or when performing household chores."
  • Willingness to be randomized to either study group and to participate in all aspects of study assessment and intervention

Exclusion Criteria:

  • Diagnosed neurological disorder or injury of the central nervous system, or observation of symptoms consistent with such a condition (Alzheimer's, Parkinson's, stroke, etc.)
  • Contraindications to non-invasive brain stimulation (e.g., metal in head, wound on scalp)
  • Contraindications to magnetic resonance imaging (e.g., metal in body, claustrophobia, etc).
  • Use of medications affecting the central nervous system
  • severe arthritis, such as awaiting joint replacement
  • severe obesity (body mass index > 35)
  • current cardiovascular, lung or renal disease; diabetes; terminal illness
  • myocardial infarction or major heart surgery in the previous year
  • cancer treatment in the past year, except for nonmelanoma skin cancers and cancers having an excellent prognosis (e.g., early stage breast or prostate cancer)
  • current diagnosis of schizophrenia, other psychotic disorders, or bipolar disorder
  • uncontrolled hypertension at rest (systolic > 180 mmHg and/or diastolic > 100 mmHg)
  • bone fracture or joint replacement in the previous six months
  • current participation in physical therapy for lower extremity function or cardiopulmonary rehabilitation
  • current enrollment in any clinical trial
  • difficulty communicating with study personnel, and/or non-English speaking
  • planning to relocate out of the area during the study period
  • clinical judgment of investigative team regarding safety or non-compliance

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03790657


Contacts
Contact: David J Clark, DSc (352) 376-1611 ext 5244 David.Clark1@va.gov
Contact: Dorian K Rose, PhD MS BS (352) 273-8307 Dorian.Rose@va.gov

Locations
United States, Florida
North Florida/South Georgia Veterans Health System, Gainesville, FL Not yet recruiting
Gainesville, Florida, United States, 32608
Contact: Margaret H McCallum    352-376-1611 ext 5223    Margaret.McCallum@va.gov   
Contact: Heidi Parrish    (352) 376-1611 ext 105246    heidi.parrish@va.gov   
Principal Investigator: David J. Clark, DSc         
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: David J. Clark, DSc North Florida/South Georgia Veterans Health System, Gainesville, FL

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT03790657     History of Changes
Other Study ID Numbers: E3115-R
I01RX003115 ( Other Grant/Funding Number: VA RR&D )
First Posted: December 31, 2018    Key Record Dates
Last Update Posted: January 3, 2019
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: A Limited Dataset will be created and shared pursuant to a Data Use Agreement appropriately limiting use of the dataset and prohibiting the recipient from identifying or re-identifying (or taking steps to identify or re-identify) any individual whose data are included in the dataset.
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: The Limited Dataset will be completed after the study is completed and primary/secondary data accepted for publication.

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

Keywords provided by VA Office of Research and Development:
aging
walking
brain
electrical stimulation