Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT03036319 |
Other study ID # |
HUM00111090 |
Secondary ID |
|
Status |
Recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
June 2016 |
Est. completion date |
April 2026 |
Study information
Verified date |
November 2023 |
Source |
University of Michigan |
Contact |
Kayla Rinna, M.S. |
Phone |
734-936-7739 |
Email |
krinna[@]med.umich.edu |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
As individuals grow older, a number of factors can reduce our cognitive (or thinking)
abilities such as "normal" aging, neurodegenerative diseases, and cardiovascular disease.
This study will evaluate whether cognitive rehabilitation and transcranial electrical
stimulation (TES) can improve cognitive abilities. Cognitive rehabilitation refers to methods
that are used to improve tasks people have trouble doing in everyday life. Transcranial
electrical stimulation uses small amounts of electricity to try to alter brain functioning.
These approaches may help improve cognitive abilities like attention, learning, memory,
finding words, and problem solving as well as everyday functioning. The goal of this study is
to identify how to best use these methods, either alone or in combination.
Description:
The primary objective of this study is to evaluate the feasibility of a neurorehabilitation
treatment tailored to individual patient needs, with the ultimate goal of maximizing
cognitive and real-world functioning for older adults with cognitive aging, mild cognitive
impairment (MCI), neurodegenerative, or other neurological diseases/conditions.
Transcranial electrical stimulation (TES) is a non-invasive, neurorehabilitation procedure in
which a weak electric current is passed between electrodes that are placed on the scalp with
the intention of modulating excitability of the underlying brain regions. Because the field
of TES is relatively young, rapidly evolving, and primarily focused on cognitive neuroscience
with "healthy" individuals, there is a clear need for well-conceptualized and conducted
clinical research. The current protocol is intentionally broad with respect to both
methodology and patient characteristics in order to tailor potential TES interventions to
individual patients or small samples. The current protocol utilizes various forms of TES
including transcranial direct current stimulation (tDCS), alternating current stimulation
(tACS), and random noise stimulation (tRNS) and sham stimulation in older adults. As this is
a cross-over design, some participants may receive active (or "real") TES and/or sham TES
conditions.This includes head to head comparisons of the different forms of TES.
Additionally, TES could be performed in conjunction with cognitively-based intervention since
this may enhance the neuroplastic response of the targeted brain region(s) while at the same
time shaping/optimizing the pathways that are engaged by cognitively-based interventions.
This broad approach is important since etiological differences in cognitive impairment may
necessitate distinct interventions.