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Patient-Centered NeuroRehabilitation (PCN) (PCN)

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ClinicalTrials.gov Identifier: NCT03036319
Recruitment Status : Recruiting
First Posted : January 30, 2017
Last Update Posted : May 13, 2019
Sponsor:
Information provided by (Responsible Party):
Benjamin Hampstead, PhD, University of Michigan

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.

Condition or disease Intervention/treatment Phase
Cognitive Deficit Device: Active tDCS Device: Sham tDCS Behavioral: Cognitively based intervention Device: Active tACS Device: Sham tACS Device: Active tRNS Device: Sham tRNS Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: Patient-Centered NeuroRehabilitation
Study Start Date : June 2016
Estimated Primary Completion Date : April 2026
Estimated Study Completion Date : April 2026

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.

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

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

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

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

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: 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: Sham tDCS
Participants will receive sham tDCS 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

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: Sham tACS
Participants will receive sham transcranial alternating current stimulation 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 tRNS
Participants will receive sham transcranial random noise stimulation 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: Sham tDCS
Participants will receive sham tDCS 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: Sham tACS
Participants will receive sham transcranial alternating current stimulation 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 tRNS
Participants will receive sham transcranial random noise stimulation for up to 260 sessions




Primary Outcome Measures :
  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


Other Outcome Measures:
  1. Cognitive changes as assessed by neuropsychological testing [ Time Frame: Baseline to post-TES/cognitive based interventions within 4-6 weeks, with 3 and 6 month follow-up, all of which is within one year; note, not all participants will receive this time frame. ]
    Investigators will administer neuropsychological testing (e.g. memory tests, sorting tasks, etc.) selected on an individual basis before and after TES/cognitive based interventions to determine if the treatment intervention contributed to any cognitive changes (e.g. memory performance, executive function improvement, etc.). This may be individually based and measured using raw or z-scores as appropriate.

  2. Symptomatic changes as assessed by structured questionnaires [ Time Frame: Pre, post, and follow-up at up to 1 year post treatment ]
    Investigators will administer patient-centered questionnaires (e.g., cognitive, emotional, physical questionnaires) before and after TES/cognitive based interventions to determine if the treatment intervention contributed to any symptomatic changes. This will be individually based and measured using raw or z-scores as appropriate. Not all participants will complete questionnaires.

  3. Blood oxygen level dependent (BOLD) changes as assessed by functional magnetic resonance imaging (fMRI) [ Time Frame: Pre, post, and follow-up at up to 1 year post treatment ]
    Investigators will use the fMRI images taken from before and after TES/cognitive based interventions to determine if the treatment intervention contributed to any changes within the neural networks. Not all participants will undergo MRI.

  4. Magnetic resonance spectroscopy [ Time Frame: Pre, post, and follow-up at up to 1 year post treatment ]
    Change in MRS data (e.g., Glutamine, glutamate, GABA) levels vs. baseline(s). Not all participants will undergo MRS



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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 serious mental illness (e.g., bipolar disorder, schizophrenia, axis 2 disorders)
  2. Sensory or motor impairments that limit the ability to take part in the study
  3. A significant history or current use of 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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03036319


Contacts
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Contact: Benjamin M Hampstead, Ph.D. 734-936-9277 bhampste@med.umich.edu
Contact: Arijit K Bhaumik, B.A. 734-936-8281 arijit@med.umich.edu

Locations
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United States, Michigan
University of Michigan - Department of Psychiatry Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Arijit K Bhaumik, B.A.    734-936-8281    arijit@umich.edu   
Contact: Annalise M Rahman-Filipiak, Ph.D    734-936-3180    rahmanam@med.umich.edu   
Principal Investigator: Benjamin M Hampstead, Ph.D.         
Sponsors and Collaborators
University of Michigan
Investigators
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Principal Investigator: Benjamin M Hampstead, Ph.D. University of Michigan

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Responsible Party: Benjamin Hampstead, PhD, Investigator, University of Michigan
ClinicalTrials.gov Identifier: NCT03036319     History of Changes
Other Study ID Numbers: HUM00111090
First Posted: January 30, 2017    Key Record Dates
Last Update Posted: May 13, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Cognition Disorders
Cognitive Dysfunction
Neurocognitive Disorders
Mental Disorders