Patient-Centered NeuroRehabilitation (PCN) (PCN)

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.

Study Overview

• Status: Recruiting
• Conditions: Cognitive Deficit
• Intervention / Treatment: Device: Active tDCS; Device: Active tACS; Device: Active tRNS; Device: Sham tDCS; Device: Sham tACS; Device: Sham tRNS; Behavioral: Cognitively based intervention

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 Type: Interventional
• Enrollment (Estimated): 500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eileen Robinson, RN, MPH; Phone Number: 734-763-1356; Email: robinsoe@med.umich.edu
• Study Contact Backup: Name: Kayla Rinna, M.S.; Phone Number: 734-936-7739; Email: krinna@med.umich.edu

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Recruiting
      • University of Michigan - Department of Psychiatry
      • Contact: Victor DiRita, B.S.; Phone Number: 734-936-0985; Email: victordi@med.umich.edu
      • Principal Investigator: Benjamin M Hampstead, Ph.D.
      • Contact: Kayla Rinna, M.S.; Phone Number: 734-936-7739; Email: krinna@med.umich.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Device: Active tDCS; Participants will receive active tDCS at up to 4mA per electrode for up to 40 minutes for up to 260 sessions.; Device: 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; Device: 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
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.	Device: Sham tDCS; Participants will receive sham tDCS for up to 260 sessions; Device: Sham tACS; Participants will receive sham transcranial alternating current stimulation for up to 260 sessions; Device: Sham tRNS; Participants will receive sham transcranial random noise 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.	Behavioral: 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
Experimental: Active TES + Cognitively based intervention; This condition combines active TES and cognitively based interventions for some or all of the study sessions	Device: Active tDCS; Participants will receive active tDCS at up to 4mA per electrode for up to 40 minutes for up to 260 sessions.; Device: 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; Device: 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; Behavioral: 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
Experimental: Sham TES + Cognitively based intervention; This condition combines sham TES and cognitively based interventions for some or all of the study sessions	Device: Sham tDCS; Participants will receive sham tDCS for up to 260 sessions; Device: Sham tACS; Participants will receive sham transcranial alternating current stimulation for up to 260 sessions; Device: Sham tRNS; Participants will receive sham transcranial random noise stimulation for up to 260 sessions; Behavioral: 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
Experimental: Active TES, Sham TES, Cognitively based interventions; This condition combines active and sham TES with cognitively based interventions using a cross-over design	Device: Active tDCS; Participants will receive active tDCS at up to 4mA per electrode for up to 40 minutes for up to 260 sessions.; Device: 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; Device: 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; Device: Sham tDCS; Participants will receive sham tDCS for up to 260 sessions; Device: Sham tACS; Participants will receive sham transcranial alternating current stimulation for up to 260 sessions; Device: Sham tRNS; Participants will receive sham transcranial random noise stimulation for up to 260 sessions; Behavioral: 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
Experimental: Active and Sham TES; Participants will receive active and sham TES	Device: Active tDCS; Participants will receive active tDCS at up to 4mA per electrode for up to 40 minutes for up to 260 sessions.; Device: 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; Device: 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; Device: Sham tDCS; Participants will receive sham tDCS for up to 260 sessions; Device: Sham tACS; Participants will receive sham transcranial alternating current stimulation for up to 260 sessions; Device: Sham tRNS; Participants will receive sham transcranial random noise stimulation for up to 260 sessions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: University of Michigan
• Investigators: Principal Investigator: Benjamin M Hampstead, Ph.D., University of Michigan

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027

Study Registration Dates

• First Submitted: January 25, 2017
• First Submitted That Met QC Criteria: January 25, 2017
• First Posted (Estimated): January 30, 2017

Study Record Updates

• Last Update Posted (Estimated): January 14, 2026
• Last Update Submitted That Met QC Criteria: January 12, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders
• Other Study ID Numbers: HUM00111090

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• product manufactured in and exported from the U.S.: No