Patient-Centered NeuroRehabilitation (PCN)
PCN
1 other identifier
interventional
500
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2016
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2016
CompletedFirst Submitted
Initial submission to the registry
January 25, 2017
CompletedFirst Posted
Study publicly available on registry
January 30, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2027
January 14, 2026
January 1, 2026
11.4 years
January 25, 2017
January 12, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
TES side effect questionnaire
Side effect questionnaire that asks participants to rate the severity of potential TES related side effects
Immediately following TES (<15 minutes)
Study Arms (7)
Active TES
EXPERIMENTALParticipants 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 COMPARATORParticipants 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
EXPERIMENTALParticipants 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
EXPERIMENTALThis condition combines active TES and cognitively based interventions for some or all of the study sessions
Sham TES + Cognitively based intervention
EXPERIMENTALThis condition combines sham TES and cognitively based interventions for some or all of the study sessions
Active TES, Sham TES, Cognitively based interventions
EXPERIMENTALThis condition combines active and sham TES with cognitively based interventions using a cross-over design
Active and Sham TES
EXPERIMENTALParticipants will receive active and sham TES
Interventions
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
Eligibility Criteria
You may qualify if:
- Individuals who have reported cognitive dysfunction and cognitively intact participants.
- Participants will be age 50 or older
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Michigan - Department of Psychiatry
Ann Arbor, Michigan, 48109, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Benjamin M Hampstead, Ph.D.
University of Michigan
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Masking Details
- Given the nature of this study, the participant, care provider, investigator, and/or outcome assessors may or may not be blinded to the treatment condition.
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Investigator
Study Record Dates
First Submitted
January 25, 2017
First Posted
January 30, 2017
Study Start
June 1, 2016
Primary Completion (Estimated)
November 1, 2027
Study Completion (Estimated)
November 1, 2027
Last Updated
January 14, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share