University of Michigan - Department of Psychiatry
Ann Arbor, Michigan, 48109, United States
Location status: Recruiting
Location contact
Benjamin M Hampstead, Ph.D.
PRINCIPAL_INVESTIGATOR
Kayla Rinna, M.S.
CONTACT
Victor DiRita, B.S.
CONTACT
NCT Number: NCT03036319
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.
Interested in participating?
Request Info50 year and older
All sexes
Interventional
Not applicable
Ann Arbor, Michigan, 48109, United States
Location status: Recruiting
Benjamin M Hampstead, Ph.D.
PRINCIPAL_INVESTIGATOR
Kayla Rinna, M.S.
CONTACT
Victor DiRita, B.S.
CONTACT
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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 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
Time frame: Immediately following TES (<15 minutes)
Side effect questionnaire that asks participants to rate the severity of potential TES related side effects
Contact information is provided by the study sponsor or research team.
Eileen Robinson, RN, MPH
CONTACT
Kayla Rinna, M.S.
CONTACT
University of Michigan
Other
Patient-Centered NeuroRehabilitation
Acronym: PCN
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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