An interventional study of Active tDCS and Sham tDCS in Cognitive Deficit, sponsored by University of Michigan. Recruiting at 1 site in United States. Open to participants aged 50 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-14.
Sponsored by University of Michigan · Not applicable, Interventional, and Treatment
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.
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.
411 studies on the registry are indexed under Cognition Disorders; 90 are open to participants now.
This study's planned enrollment of 500 is above the median of 60 across 287 interventional studies indexed under Cognition Disorders.
Browse Cognition Disorders studies →University of Michigan is the lead sponsor of 1,475 studies on the registry; 196 are open to participants now.
Of its 162 completed or terminated interventional studies of FDA-regulated products, 128 (79%) have results posted.
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Exclusion Criteria:
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
Participants will receive "real" tES (tDCS, tACS, tRNS) in which they receive up to 4 milliamps (mA) of stimulation per electrode for up to 40 minutes for up to 260 sessions. As this may be a cross-over design, some participants may receive active and sham conditions.
Device: Active tDCS · Device: Active tACS · Device: Active tRNS
Participants undergoing this condition will have the exact same procedures as the active group, with the exception that they will receive only sham stimulation for up to 260 sessions.
Device: Sham tDCS · Device: Sham tACS · Device: Sham tRNS
Participants may receive a cognitively based intervention that targets the particular cognitive and/or functional abilities of interest. This includes methods of cognitive training, cognitive remediation, and cognitive rehabilitation.
Behavioral: Cognitively based intervention
This condition combines active TES and cognitively based interventions for some or all of the study sessions
Device: Active tDCS · Behavioral: Cognitively based intervention · Device: Active tACS · Device: Active tRNS
This condition combines sham TES and cognitively based interventions for some or all of the study sessions
Device: Sham tDCS · Behavioral: Cognitively based intervention · Device: Sham tACS · Device: Sham tRNS
This condition combines active and sham TES with cognitively based interventions using a cross-over design
Device: Active tDCS · Device: Sham tDCS · Behavioral: Cognitively based intervention · Device: Active tACS · Device: Sham tACS · Device: Active tRNS · Device: Sham tRNS
Participants will receive active and sham TES
Device: Active tDCS · Device: Sham tDCS · Device: Active tACS · Device: Sham tACS · Device: Active tRNS · Device: Sham tRNS
Participants will receive active tDCS at up to 4mA per electrode for up to 40 minutes for up to 260 sessions.
Participants will receive sham tDCS for up to 260 sessions
Participants may receive a cognitively based intervention that targets the particular cognitive and/or functional abilities of interest. This includes methods of cognitive training, cognitive remediation, and cognitive rehabilitation for up to 260 sessions
Participants will receive active transcranial alternating current stimulation at up to 4mA per electrode for up to 40 minutes for up to 260 sessions
Participants will receive sham transcranial alternating current stimulation for up to 260 sessions
Participants will receive active transcranial random noise stimulation at up to 4mA per electrode for up to 40 minutes for up to 260 sessions
Participants will receive sham transcranial random noise stimulation for up to 260 sessions
TES side effect questionnaire
Side effect questionnaire that asks participants to rate the severity of potential TES related side effects
Time frame: Immediately following TES (<15 minutes)
Plan to share: No
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