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Patient-Centered NeuroRehabilitation (PCN) (PCN)

Primary Purpose

Cognitive Deficit

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Active tDCS
Sham tDCS
Cognitively based intervention
Active tACS
Sham tACS
Active tRNS
Sham tRNS
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cognitive Deficit

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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., 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

Sites / Locations

  • University of Michigan - Department of PsychiatryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Experimental

Placebo Comparator

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Active TES

Sham TES

Cognitively based intervention

Active TES + Cognitively based intervention

Sham TES + Cognitively based intervention

Active TES, Sham TES, Cognitively based interventions

Active and Sham TES

Arm Description

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.

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.

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.

This condition combines active TES and cognitively based interventions for some or all of the study sessions

This condition combines sham TES and cognitively based interventions for some or all of the study sessions

This condition combines active and sham TES with cognitively based interventions using a cross-over design

Participants will receive active and sham TES

Outcomes

Primary Outcome Measures

TES side effect questionnaire
Side effect questionnaire that asks participants to rate the severity of potential TES related side effects

Secondary Outcome Measures

Full Information

First Posted
January 25, 2017
Last Updated
November 23, 2022
Sponsor
University of Michigan
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1. Study Identification

Unique Protocol Identification Number
NCT03036319
Brief Title
Patient-Centered NeuroRehabilitation (PCN)
Acronym
PCN
Official Title
Patient-Centered NeuroRehabilitation
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 2016 (undefined)
Primary Completion Date
April 2026 (Anticipated)
Study Completion Date
April 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Deficit

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study 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.
Allocation
Non-Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active TES
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham TES
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Cognitively based intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Active TES + Cognitively based intervention
Arm Type
Experimental
Arm Description
This condition combines active TES and cognitively based interventions for some or all of the study sessions
Arm Title
Sham TES + Cognitively based intervention
Arm Type
Experimental
Arm Description
This condition combines sham TES and cognitively based interventions for some or all of the study sessions
Arm Title
Active TES, Sham TES, Cognitively based interventions
Arm Type
Experimental
Arm Description
This condition combines active and sham TES with cognitively based interventions using a cross-over design
Arm Title
Active and Sham TES
Arm Type
Experimental
Arm Description
Participants will receive active and sham TES
Intervention Type
Device
Intervention Name(s)
Active tDCS
Intervention Description
Participants will receive active tDCS at up to 4mA per electrode for up to 40 minutes for up to 260 sessions.
Intervention Type
Device
Intervention Name(s)
Sham tDCS
Intervention Description
Participants will receive sham tDCS for up to 260 sessions
Intervention Type
Behavioral
Intervention Name(s)
Cognitively based intervention
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Active tACS
Intervention Description
Participants will receive active transcranial alternating current stimulation at up to 4mA per electrode for up to 40 minutes for up to 260 sessions
Intervention Type
Device
Intervention Name(s)
Sham tACS
Intervention Description
Participants will receive sham transcranial alternating current stimulation for up to 260 sessions
Intervention Type
Device
Intervention Name(s)
Active tRNS
Intervention Description
Participants will receive active transcranial random noise stimulation at up to 4mA per electrode for up to 40 minutes for up to 260 sessions
Intervention Type
Device
Intervention Name(s)
Sham tRNS
Intervention Description
Participants will receive sham transcranial random noise stimulation for up to 260 sessions
Primary Outcome Measure Information:
Title
TES side effect questionnaire
Description
Side effect questionnaire that asks participants to rate the severity of potential TES related side effects
Time Frame
Immediately following TES (<15 minutes)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Individuals who have reported cognitive dysfunction and cognitively intact participants. Participants will be age 50 or older Exclusion Criteria: A history of serious mental illness (e.g., schizophrenia, axis 2 disorders) Sensory or motor impairments that limit the ability to take part in the study A significant history or current use of 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stephen Schlaefflin, B.S
Phone
734-936-7360
Email
schlst@med.umich.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Eileen Robinson, RN, MPH
Phone
734-763-1356
Email
robinsoe@med.umich.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benjamin M Hampstead, Ph.D.
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan - Department of Psychiatry
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Victor DiRita, B.S.
Phone
734-936-0985
Email
victordi@med.umich.edu
First Name & Middle Initial & Last Name & Degree
Stephen Schlaefflin, B.S
Phone
734-936-7360
Email
schlst@med.umich.edu
First Name & Middle Initial & Last Name & Degree
Benjamin M Hampstead, Ph.D.

12. IPD Sharing Statement

Plan to Share IPD
No

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Patient-Centered NeuroRehabilitation (PCN)

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