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NCT Number: NCT03036319

Patient-Centered NeuroRehabilitation (PCN)

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.

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

[email protected]

734-936-7739

Victor DiRita, B.S.

CONTACT

[email protected]

734-936-0985

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • A history of epilepsy
  • Sensory or motor impairments that limit the ability to take part in the study
  • Current 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

Treatment and study plan

active tDCS

Device

Participants will receive active tDCS at up to 4mA per electrode for up to 40 minutes for up to 260 sessions.

Sham tDCS

Device

Participants will receive sham tDCS for up to 260 sessions

Cognitively based intervention

Behavioral

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

Active tACS

Device

Participants will receive active transcranial alternating current stimulation at up to 4mA per electrode for up to 40 minutes for up to 260 sessions

Sham tACS

Device

Participants will receive sham transcranial alternating current stimulation for up to 260 sessions

Active tRNS

Device

Participants will receive active transcranial random noise stimulation at up to 4mA per electrode for up to 40 minutes for up to 260 sessions

sham tRNS

Device

Participants will receive sham transcranial random noise stimulation for up to 260 sessions

Primary outcomes

  1. TES side effect questionnaire

    Time frame: Immediately following TES (<15 minutes)

    Side effect questionnaire that asks participants to rate the severity of potential TES related side effects

Study contacts

Contact information is provided by the study sponsor or research team.

Eileen Robinson, RN, MPH

CONTACT

[email protected]

734-763-1356

Kayla Rinna, M.S.

CONTACT

[email protected]

734-936-7739

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Official study title

Patient-Centered NeuroRehabilitation

Acronym: PCN

Important dates

Study start
2016
Primary completion
2027
Study completion
2027
First posted
Jan 30, 2017
Registry last updated
Jan 14, 2026

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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