Cognitive DeficitPCNNCT03036319
Patient-Centered NeuroRehabilitation (PCN)
A study testing Active tDCS, Cognitively based intervention and Active tACS in people with Cognitive Deficit, run by University of Michigan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cognitive Deficit
- What is being tested?
- Active tDCS, Cognitively based intervention and Active tACS
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2016to Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Individuals who have reported cognitive dysfunction and cognitively intact participants.
- Participants will be age 50 or older
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Michigan - Department of Psychiatry
Ann Arbor, Michigan, 48109
Victor DiRita, B.S., 734-936-0985, victordi@med.umich.edu
Kayla Rinna, M.S., 734-936-7739, krinna@med.umich.edu
About this study
Official title: Patient-Centered NeuroRehabilitation
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.
Read the detailed 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.
- Conditions
- Cognitive Deficit
- Being tested
- Active tDCS, Sham tDCS, Cognitively based intervention, Active tACS, Sham tACS
- Medical subject headings
- Cognition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active tDCSDevice
Participants will receive active tDCS at up to 4mA per electrode for up to 40 minutes for up to 260 sessions.
Sham tDCSDevice
Participants will receive sham tDCS for up to 260 sessions
Cognitively based interventionBehavioural
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 tACSDevice
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 tACSDevice
Participants will receive sham transcranial alternating current stimulation for up to 260 sessions
Active tRNSDevice
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 tRNSDevice
Participants will receive sham transcranial random noise stimulation for up to 260 sessions
| Study group | Role | What they receive |
|---|---|---|
| Active TES | Experimental | 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. Receives: Device: Active tDCS; Device: Active tACS; Device: Active tRNS |
| Sham TES | Placebo comparator | 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. Receives: Device: Sham tDCS; Device: Sham tACS; Device: Sham tRNS |
| Cognitively based intervention | Experimental | 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. Receives: Behavioral: Cognitively based intervention |
| Active TES + Cognitively based intervention | Experimental | This condition combines active TES and cognitively based interventions for some or all of the study sessions Receives: Device: Active tDCS; Behavioral: Cognitively based intervention; Device: Active tACS; Device: Active tRNS |
| Sham TES + Cognitively based intervention | Experimental | This condition combines sham TES and cognitively based interventions for some or all of the study sessions Receives: Device: Sham tDCS; Behavioral: Cognitively based intervention; Device: Sham tACS; Device: Sham tRNS |
| Active TES, Sham TES, Cognitively based interventions | Experimental | This condition combines active and sham TES with cognitively based interventions using a cross-over design Receives: Device: Active tDCS; Device: Sham tDCS; Behavioral: Cognitively based intervention; Device: Active tACS; Device: Sham tACS; Device: Active tRNS; Device: Sham tRNS |
| Active and Sham TES | Experimental | Participants will receive active and sham TES Receives: Device: Active tDCS; Device: Sham tDCS; Device: Active tACS; Device: Sham tACS; Device: Active tRNS; Device: Sham tRNS |
What is being measured
The primary outcome is the main question the study is designed to answer.
TES side effect questionnaire
Side effect questionnaire that asks participants to rate the severity of potential TES related side effects
Measured: Immediately following TES (<15 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2017 (estimated)
- Study startJun 2016
- Primary completionNov 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive DeficitStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Benjamin Hampstead, PhD, University of Michigan
- Investigators
- Benjamin M Hampstead, Ph.D., Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03036319
- Sponsor's protocol ID
- HUM00111090
- Acronym
- PCN
- Status last verified
- Jan 2026
- First submitted
- 25 Jan 2017
- Last updated
- 14 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-Centered NeuroRehabilitation
- ClinicalTrials.gov ID
- NCT03036319
- Acronym / sponsor ID
- PCN / HUM00111090
- Conditions
- Cognitive Deficit
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 30 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Active TES | Experimental | Device: Active tDCS, Device: Active tACS, Device: Active tRNSParticipants 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. |
| Sham TES | Placebo comparator | Device: Sham tDCS, Device: Sham tACS, Device: Sham tRNSParticipants 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. |
| Cognitively based intervention | Experimental | Behavioral: Cognitively based interventionParticipants 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. |
| Active TES + Cognitively based intervention | Experimental | Device: Active tDCS, Behavioral: Cognitively based intervention, Device: Active tACS, Device: Active tRNSThis condition combines active TES and cognitively based interventions for some or all of the study sessions |
| Sham TES + Cognitively based intervention | Experimental | Device: Sham tDCS, Behavioral: Cognitively based intervention, Device: Sham tACS, Device: Sham tRNSThis condition combines sham TES and cognitively based interventions for some or all of the study sessions |
| Active TES, Sham TES, Cognitively based interventions | Experimental | Device: Active tDCS, Device: Sham tDCS, Behavioral: Cognitively based intervention, Device: Active tACS, Device: Sham tACS, Device: Active tRNS, Device: Sham tRNSThis condition combines active and sham TES with cognitively based interventions using a cross-over design |
| Active and Sham TES | Experimental | Device: Active tDCS, Device: Sham tDCS, Device: Active tACS, Device: Sham tACS, Device: Active tRNS, Device: Sham tRNSParticipants will receive active and sham TES |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Individuals who have reported cognitive dysfunction and cognitively intact participants.
- Participants will be age 50 or older
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active tDCSParticipants will receive active tDCS at up to 4mA per electrode for up to 40 minutes for up to 260 sessions. | Device | Active TES, Active TES + Cognitively based intervention, Active TES, Sham TES, Cognitively based interventions, Active and Sham TES |
| Sham tDCSParticipants will receive sham tDCS for up to 260 sessions | Device | Active TES, Sham TES, Cognitively based interventions, Active and Sham TES, Sham TES, Sham TES + Cognitively based intervention |
| Cognitively based interventionParticipants 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 | Behavioural | Active TES + Cognitively based intervention, Active TES, Sham TES, Cognitively based interventions, Cognitively based intervention, Sham TES + Cognitively based intervention |
| Active tACSParticipants will receive active transcranial alternating current stimulation at up to 4mA per electrode for up to 40 minutes for up to 260 sessions | Device | Active TES, Active TES + Cognitively based intervention, Active TES, Sham TES, Cognitively based interventions, Active and Sham TES |
| Sham tACSParticipants will receive sham transcranial alternating current stimulation for up to 260 sessions | Device | Active TES, Sham TES, Cognitively based interventions, Active and Sham TES, Sham TES, Sham TES + Cognitively based intervention |
| Active tRNSParticipants will receive active transcranial random noise stimulation at up to 4mA per electrode for up to 40 minutes for up to 260 sessions | Device | Active TES, Active TES + Cognitively based intervention, Active TES, Sham TES, Cognitively based interventions, Active and Sham TES |
| Sham tRNSParticipants will receive sham transcranial random noise stimulation for up to 260 sessions | Device | Active TES, Sham TES, Cognitively based interventions, Active and Sham TES, Sham TES, Sham TES + Cognitively based intervention |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Benjamin M Hampstead, Ph.D. principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active tDCS, Cognitively based intervention and Active tACS in people with Cognitive Deficit, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kayla Rinna, M.S. (734-936-7739, krinna@med.umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TES side effect questionnaire (time frame: Immediately following TES (<15 minutes)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2026.