Recruiting

PCN

Sponsor:

University of Michigan

Code:

NCT03036319

Conditions

Cognitive Deficit

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Accepted

Interventions

Active tDCS

Sham tDCS

Cognitively based intervention

Active tACS

Sham tACS

Study Details

Brief 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.

Conditions

Cognitive Deficit

Study ID

NCT03036319

Start date

Jun, 2016

Status verified date

Jan, 2026

Completion date

Nov, 2027

Anticipated

Primary completion date

Nov, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Accepted

Inclusion Criteria:

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

Exclusion Criteria:

1. A history of epilepsy
2. Sensory or motor impairments that limit the ability to take part in the study
3. Current alcohol or drug abuse/dependence
4. 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

Study Design

Enrollment

500 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Active 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.

placebo comparator: Sham TES

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.

experimental: Cognitively based intervention

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.

experimental: Active TES + Cognitively based intervention

This condition combines active TES and cognitively based interventions for some or all of the study sessions

experimental: Sham TES + Cognitively based intervention

This condition combines sham TES and cognitively based interventions for some or all of the study sessions

experimental: Active TES, Sham TES, Cognitively based interventions

This condition combines active and sham TES with cognitively based interventions using a cross-over design

experimental: Active and Sham TES

Participants will receive active and sham TES

Interventions

Active tDCS

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

Sham tDCS

Participants will receive sham tDCS for up to 260 sessions

Cognitively based intervention

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

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

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

Active tRNS

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

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

Primary outcome measure

  • TES side effect questionnaire [ Time Frame: Immediately following TES (<15 minutes) ]

Central Contacts and Locations

Central contacts

Kayla Rinna, M.S.

734-936-7739krinna@med.umich.edu

Eileen Robinson, RN, MPH

734-763-1356robinsoe@med.umich.edu

Locations

University of Michigan - Department of Psychiatry

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Victor DiRita, B.S.

734-936-0985victordi@med.umich.edu

Kayla Rinna, M.S.

734-936-7739krinna@med.umich.edu

Principal Investigator:

Benjamin M Hampstead, Ph.D.

More Information

Sponsor

University of Michigan

Last update posted

Jan 14, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Michigan on 2026-01-14.