NCT03122236

Combining tDCS and Neurorehabilitation to Treat Age-related Deficits of Mobility and Cognition: UPfront Walking Study

Completed NA Results posted Last updated 14 June 2024

What this trial tests

NA trial testing Neurorehabilitation of Standard Walking in Mobility Limitation in 20 participants. Completed in 6 March 2021.

Timeline

1 June 2017

Primary endpoint
31 May 2020

6 March 2021

Quick facts

Lead sponsor	University of Florida
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	20
Start date	1 June 2017
Primary completion	31 May 2020
Estimated completion	6 March 2021
Sites	3 locations across United States

Drugs / interventions tested

• Neurorehabilitation of Standard Walking
• Neurorehabilitation of Complex Walking
• Sham Transcranial Direct Current Stimulation (Sham tDCS)
• Active Transcranial Direct Current Stimulation (Active tDCS)

Conditions studied

• Mobility Limitation — all drugs for Mobility Limitation →
• Cognitive Impairment — all drugs for Cognitive Impairment →

Sponsor

University of Florida

Who can join

Adults 65 to 110, any sex, with Mobility Limitation or Cognitive Impairment. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Mobility: Figure-of-eight Walking Test (Figure-8 Walk Test) Primary · Change (value at 6 weeks minus value at baseline)

Time to complete a walking course at usual pace. The course is 15 feet in length and arranged as a Figure-8 pattern.

Group	Value	95% CI
Complex Walking With Active tDCS	10.57	± 1.93
Complex Walking With Sham tDCS	9.58	± 1.42
Standard Walking With Sham tDCS	11.00	± 2.00

Cognitive Composite Executive Score on EXAMINER Battery Secondary · Change (value at 6 weeks minus value at baseline)

EXAMINER is an acronym for "Executive Abilities:Measures and Instruments for Neurobehavioral Evaluation and Research. EXAMINER is a battery of assessments that tests 7 domains of executive function separately and as a composite score. The composite score is based on Item Response Theory (logistic modeling) and ranges from a minimum value of -4 to a maximum value of 4. Higher scores indicate better performance.

Group	Value	95% CI
Complex Walking With Active tDCS	-0.19	± 0.74
Complex Walking With Sham tDCS	0.29	± 0.22
Standard Walking With Sham tDCS	0.03	± 0.96

Adverse events — posted to ClinicalTrials.gov

Time frame: 6 weeks. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Complex Walking With Active tDCS

Serious: 1/7 (14%)

Deaths: 0/7

Complex Walking With Sham tDCS

Serious: 0/6 (0%)

Deaths: 0/6

Standard Walking With Sham tDCS

Serious: 0/7 (0%)

Deaths: 0/7

Serious adverse events (1 terms)

Reaction	System	Complex Walking With Activ…	Complex Walking With Sham …	Standard Walking With Sham…
kidney stones	Renal and urinary disorders	—	—	—

Other adverse events (1 terms — click to expand)

Reaction	System	Complex Walking With Activ…	Complex Walking With Sham …	Standard Walking With Sham…
Falling (no injury)	General disorders	—	—	—

Most-reported serious reactions: kidney stones.

Data from ClinicalTrials.gov NCT03122236 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Effects of Prefrontal Transcranial Direct Current Stimulation on Retention of Performance Gains on an Obstacle Negotiation Task in Older Adults.
   Chatterjee SA, Seidler RD, Skinner JW, Lysne PE, et al · · 2023 · cited 3× · PMID 35410769 · DOI 10.1016/j.neurom.2022.02.231