Patient-Centered NeuroRehabilitation (PCN) (PCN)

  • STATUS
    Recruiting
  • End date
    Apr 7, 2026
  • participants needed
    500
  • sponsor
    University of Michigan
Updated on 27 January 2022
cognitive impairment
transcranial direct current stimulation
neurodegenerative disorders
cognitive rehabilitation
Accepts healthy volunteers

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.

Details
Condition Cognitive Deficit
Treatment active tDCS, Sham tDCS, Cognitively based intervention, Active tACS, Sham tACS, Active tRNS, Sham tRNS
Clinical Study IdentifierNCT03036319
SponsorUniversity of Michigan
Last Modified on27 January 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Individuals who have reported cognitive dysfunction and cognitively intact participants
Participants will be age 50 or older

Exclusion Criteria

A history of serious mental illness (e.g., bipolar disorder, schizophrenia, axis 2 disorders)
Sensory or motor impairments that limit the ability to take part in the study
A significant history or current use of alcohol or drug abuse/dependence
Those who are currently pregnant or may become pregnant during the duration of the study (if there is a question of pregnancy, pregnancy tests will be available for participants at no charge)
Those who are being evaluated for TES methodology will also be excluded for 1)
metallic or electronic implant 2) skull plates or other cranial implants that
affect TES
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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