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Patient-Centered NeuroRehabilitation (PCN) (PCN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03036319
Recruitment Status : Suspended (Enrollment and interactions/interventions are temporarily paused due to COVID-19 and are expected to resume in the future.)
First Posted : January 30, 2017
Last Update Posted : May 28, 2020
Sponsor:
Information provided by (Responsible Party):
Benjamin Hampstead, PhD, University of Michigan

Tracking Information
First Submitted Date  ICMJE January 25, 2017
First Posted Date  ICMJE January 30, 2017
Last Update Posted Date May 28, 2020
Study Start Date  ICMJE June 2016
Estimated Primary Completion Date April 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 25, 2017)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: January 25, 2017)
  • 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.
  • 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.
  • 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.
  • 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
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Patient-Centered NeuroRehabilitation (PCN)
Official Title  ICMJE Patient-Centered NeuroRehabilitation
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Cognitive Deficit
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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.
    Interventions:
    • Device: Active tDCS
    • Device: Active tACS
    • Device: Active tRNS
  • 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.
    Interventions:
    • Device: Sham tDCS
    • Device: Sham tACS
    • Device: Sham tRNS
  • 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.
    Intervention: Behavioral: Cognitively based intervention
  • Experimental: Active TES + Cognitively based intervention
    This condition combines active TES and cognitively based interventions for some or all of the study sessions
    Interventions:
    • Device: Active tDCS
    • Behavioral: Cognitively based intervention
    • Device: Active tACS
    • Device: Active tRNS
  • Experimental: Sham TES + Cognitively based intervention
    This condition combines sham TES and cognitively based interventions for some or all of the study sessions
    Interventions:
    • Device: Sham tDCS
    • Behavioral: Cognitively based intervention
    • Device: Sham tACS
    • Device: Sham tRNS
  • Experimental: Active TES, Sham TES, Cognitively based interventions
    This condition combines active and sham TES with cognitively based interventions using a cross-over design
    Interventions:
    • Device: Active tDCS
    • Device: Sham tDCS
    • Behavioral: Cognitively based intervention
    • Device: Active tACS
    • Device: Sham tACS
    • Device: Active tRNS
    • Device: Sham tRNS
  • Experimental: Active and Sham TES
    Participants will receive active and sham TES
    Interventions:
    • Device: Active tDCS
    • Device: Sham tDCS
    • Device: Active tACS
    • Device: Sham tACS
    • Device: Active tRNS
    • Device: Sham tRNS
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Estimated Enrollment  ICMJE
 (submitted: May 9, 2019)
500
Original Estimated Enrollment  ICMJE
 (submitted: January 25, 2017)
75
Estimated Study Completion Date  ICMJE April 2026
Estimated Primary Completion Date April 2026   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03036319
Other Study ID Numbers  ICMJE HUM00111090
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Benjamin Hampstead, PhD, University of Michigan
Study Sponsor  ICMJE University of Michigan
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Benjamin M Hampstead, Ph.D. University of Michigan
PRS Account University of Michigan
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP