Combining tDCS and Neurorehabilitation to Treat Age-related Deficits of Mobility and Cognition: UPfront Walking Study
2 other identifiers
interventional
20
1 country
3
Brief Summary
Loss of mobility and cognitive ability are serious conditions that threaten the independence of older adults. The objective of this study is to initiate a line of research to develop a novel therapeutic intervention to enhance both mobility and cognition via neuroplasticity of frontal/executive circuits.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2017
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 7, 2017
CompletedFirst Posted
Study publicly available on registry
April 20, 2017
CompletedStudy Start
First participant enrolled
June 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 6, 2021
CompletedResults Posted
Study results publicly available
June 14, 2024
CompletedJune 14, 2024
June 1, 2024
3 years
April 7, 2017
February 23, 2024
June 13, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Mobility: Figure-of-eight Walking Test (Figure-8 Walk Test)
Time to complete a walking course at usual pace. The course is 15 feet in length and arranged as a Figure-8 pattern.
Change (value at 6 weeks minus value at baseline)
Secondary Outcomes (1)
Cognitive Composite Executive Score on EXAMINER Battery
Change (value at 6 weeks minus value at baseline)
Study Arms (3)
Standard walking with Sham tDCS
ACTIVE COMPARATORNeurorehabilitation of Standard Walking and Sham Transcranial Direct Current Stimulation (Sham tDCS)
Complex walking with Sham tDCS
ACTIVE COMPARATORNeurorehabilitation of Complex Walking and Sham Transcranial Direct Current Stimulation (Sham tDCS)
Complex walking with Active tDCS
ACTIVE COMPARATORNeurorehabilitation of Complex Walking and Active Transcranial Direct Current Stimulation (Active tDCS)
Interventions
Neurorehabilitation is a behavioral therapeutic approach for enhancing the neural control of task performance by: Restoration of function, specificity of training, Sensory input to the nervous system, Intensity, Repetition and Progression of training. Neurorehabilitation of standard walking will focus on the use of typical steady state walking.
Neurorehabilitation is a behavioral therapeutic approach for enhancing the neural control of task performance by: Restoration of function, specificity of training, Sensory input to the nervous system, Intensity, Repetition and Progression of training. Neurorehabilitation of complex walking will focus on the use of walking tasks that require increased attention and executive functions. The following walking tasks will be used: over obstacles, navigating around obstacles, changing speeds, on soft surfaces (exercise mat), in dim lighting, while conversing with the therapist, up/down ramps and climbing/descending stairs.
tDCS will be used to induce positive neuromodulation of frontal/executive circuits to make them more amenable to the "activity-dependent neuroplasticity" that is known to occur with behavioral neurorehabilitation. Specifically, tDCS may facilitate the efficacy of our walking neurorehabilitation intervention by strengthening the synaptic connections within the recruited circuits.
tDCS will be used to induce positive neuromodulation of frontal/executive circuits to make them more amenable to the "activity-dependent neuroplasticity" that is known to occur with behavioral neurorehabilitation. Specifically, tDCS may facilitate the efficacy of our walking neurorehabilitation intervention by strengthening the synaptic connections within the recruited circuits.
Eligibility Criteria
You may qualify if:
- preferred 10m walking speed \< 1.0 m/s
- th-80th percentile rank (age and education corrected score) on NIH toolbox executive assessments: Card Sort Test and Flanker test
- willingness to be randomized to either intervention and to participate in all aspects of study assessment and intervention
You may not qualify if:
- contraindications to non-invasive brain stimulation and/or MRI including metal in the head, pacemaker, known abnormal cranial fissures/holes.
- difficulty communicating with study personnel
- uncontrolled hypertension at rest (systolic \> 180 mmHg and/or diastolic \> 100 mmHg)
- low vision that cannot be corrected by wearing glasses. Low visual will be operationally defined as visual acuity less than 20/70 on a standard eye chart, or difficulty performing complex walking tasks due to visual conditions affecting accurate navigation around and over obstacles (self-reported or observed by examiner).
- illiterate, due to the likelihood of difficulties performing some of the cognitive tasks
- non-English speaking, due to the likelihood of difficulties following instructions during therapy and during assessments
- use of medications that are know to modify tDCS effectiveness including those with anticholinergic, GABAergic, or glutamatergic properties, or sodium channel blockers
- clinical judgment of investigative team
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Floridalead
- National Institute on Aging (NIA)collaborator
Study Sites (3)
HealthStreet
Gainesville, Florida, 32608, United States
UF Institute on Aging
Gainesville, Florida, 32611, United States
University of Florida
Gainesville, Florida, 32611, United States
Related Publications (1)
Chatterjee SA, Seidler RD, Skinner JW, Lysne PE, Sumonthee C, Wu SS, Cohen RA, Rose DK, Woods AJ, Clark DJ. Effects of Prefrontal Transcranial Direct Current Stimulation on Retention of Performance Gains on an Obstacle Negotiation Task in Older Adults. Neuromodulation. 2023 Jun;26(4):829-839. doi: 10.1016/j.neurom.2022.02.231. Epub 2022 Apr 8.
PMID: 35410769DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. David Clark
- Organization
- University of Florida
Study Officials
- PRINCIPAL INVESTIGATOR
David Clark, ScD
University of Florida
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- To control for intensity, participants will maintain a rating of perceived exertion of 4 (moderate to strong) on the Borg Category/Ratio Scale during walking. Exertion will be adjusted by modifying walking speed and/or by modifying the rest time between walking bouts.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 7, 2017
First Posted
April 20, 2017
Study Start
June 1, 2017
Primary Completion
May 31, 2020
Study Completion
March 6, 2021
Last Updated
June 14, 2024
Results First Posted
June 14, 2024
Record last verified: 2024-06