Back to resultsHome-based Transcranial Direct Current Stimulation for Pain Management in Persons With Alzheimer's Disease and Related Dementias
Primary Purpose
Alzheimer's Disease and Related Dementias
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Active tDCS
Sham tDCS
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer's Disease and Related Dementias
Eligibility Criteria
Inclusion Criteria:
- early-stage Alzhimer's disease and related dementias (ADRD)
- have caregiver-reported chronic pain (average pain in the past 3 months ≥ 3 out of 10),
- have a caregiver willing to participate in the study who sees the participant at least 10 hours/week
- can speak and read English
- have no plans to change medication regimens during the trial
Exclusion Criteria:
- history of brain surgery, brain tumor, seizure, stroke, or intracranial metal implantation
- alcohol/substance abuse
- severely diminished cognitive function (i.e., MiniMental Status Exam score ≤ 15)
- hospitalization within the preceding year for neuropsychiatric illness
Sites / Locations
- The University of Texas Health Science Center at Houston
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Active tDCS
Sham tDCS
Arm Description
Outcomes
Primary Outcome Measures
Pain as Assessed by the Mobilization-Observation-Behavior-Intensity-Dementia (MOBID-2) Scale
Mobilization-Observation-Behavior-Intensity-Dementia (MOBID-2) is a 10 question scale, each question rated from 0-10. The total score ranges between 0-100 with a higher number indicating a worse outcome. The change in total score between the baseline (day 1) and the end of intervention (day 5) is reported.
Secondary Outcome Measures
Clinical Pain as Assessed by a Numerical Rating Scale (NRS)
Numeric Rating Scale (NRS) total score ranges from 0 (no pain) to 100 (most intense pain imaginable). The change in total score between the baseline (day 1) and the end of intervention (day 5) is reported.
Behavioral and Psychological Symptoms of Dementia (BPSD) as Measured by the Cohen-Mansfield Agitation Inventory (CMAI)
Cohen-Mansfield Agitation Inventory (CMAI) is a 29 question scale, each question measured from 1-7. Total score ranges from 29-203 with a higher score indicating a worse outcome. The change in total score between the baseline (day 1) and the end of intervention (day 5) is reported.
Behavioral and Psychological Symptoms as Assessed by Neuropsychiatric Inventory (NPI)
Neuropsychiatric Inventory (NPI) total score ranges from 0-144, with a higher score indicating greater symptoms. The change in total score between the baseline (day 1) and the end of intervention (day 5) is reported.
Change in Pain Related Cortical Response Using a Continuous Wave, Multichannel Functional Near-infrared Spectroscopy (fNIRS) Imaging System
Pain-related cortical response will be measured during thermal pain stimulation using a continuous-wave, multichannel fNIRS imaging system (LIGHTNIRS, Shimadzu, Kyoto, Japan) composed of 8 source and 8 detector channels.
fNIRS signals between each source-to-detector pair are analyzed using a general linear model, Y = X*Beta + E , to test for statistical differences between the baseline (day 1) and the end of intervention (day 5).
Y is the measured fNIRS signal, X is an array encoding the expected/hypothetical response, E is an error term, and Beta is interpreted as the strength/amplitude of the functional activation.
Greater absolute Beta values denote that the change in cortical response between two sessions is greater.
The calculated Beta values are expressed in arbitrary units.
Acceptability as Measured by the tDCs Experience Questionnaire
The tDCS experience questionnaire contains 10 questions based on a scale from 0-10, 0 being strongly disagree and 10 being strongly agree. Higher scores indicating greater acceptability for 7 questions and lower scores indicating greater acceptability for 3 reversed questions. Total score ranges from 0-100 with a most desirable score of a 70.
Patient Satisfaction as Measured by the Client Satisfaction Questionnaire (CSQ)
Client Satisfaction Questionnaire (CSQ) consists of 8 questions, each is rated between 1-4. The total score ranges from 8-32 with a higher score indicating a higher satisfaction.
Full Information
NCT ID
NCT04457973
First Posted
July 1, 2020
Last Updated
September 20, 2023
Sponsor
Florida State University
Collaborators
National Institute of Nursing Research (NINR)
1. Study Identification
Unique Protocol Identification Number
NCT04457973
Brief Title
Home-based Transcranial Direct Current Stimulation for Pain Management in Persons With Alzheimer's Disease and Related Dementias
Official Title
Home-based Transcranial Direct Current Stimulation (tDCS) for Pain Management in Persons With Alzheimer's Disease and Related Dementias
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
September 4, 2020 (Actual)
Primary Completion Date
October 19, 2022 (Actual)
Study Completion Date
October 19, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Florida State University
Collaborators
National Institute of Nursing Research (NINR)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief Summary
The purpose of this project is to evaluate the preliminary effects of home-based M1-SO applied tDCS (that is, tDCS with the anode over the primary motor cortex and the cathode over the contralateral supraorbital area) on clinical pain in persons with early-stage Alzheimer's disease and Related Dementias (ADRD), to evaluate the preliminary effects of home-based M1-SO applied tDCS on pain-related cortical response in persons with early-stage ADRD, and to evaluate the feasibility and acceptability of home-based M1-SO applied tDCS for pain management in persons with early-stage AD.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease and Related Dementias
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active tDCS
Arm Type
Experimental
Arm Title
Sham tDCS
Arm Type
Placebo Comparator
Intervention Type
Device
Intervention Name(s)
Active tDCS
Intervention Description
tDCS with a constant current intensity of 2 milliampere (mA) will be applied for 20 minutes per session daily for 5 days via the Soterix 1x1 tDCS mini-CT Stimulator device with headgear and 5x7 cm saline-soaked surface sponge electrodes.
Intervention Type
Device
Intervention Name(s)
Sham tDCS
Intervention Description
The electrodes will be placed in the same positions as for active stimulation, but the stimulator will only deliver 2 mA current for 30 seconds.
Primary Outcome Measure Information:
Title
Pain as Assessed by the Mobilization-Observation-Behavior-Intensity-Dementia (MOBID-2) Scale
Description
Mobilization-Observation-Behavior-Intensity-Dementia (MOBID-2) is a 10 question scale, each question rated from 0-10. The total score ranges between 0-100 with a higher number indicating a worse outcome. The change in total score between the baseline (day 1) and the end of intervention (day 5) is reported.
Time Frame
baseline (day 1), end of intervention (day 5)
Secondary Outcome Measure Information:
Title
Clinical Pain as Assessed by a Numerical Rating Scale (NRS)
Description
Numeric Rating Scale (NRS) total score ranges from 0 (no pain) to 100 (most intense pain imaginable). The change in total score between the baseline (day 1) and the end of intervention (day 5) is reported.
Time Frame
baseline (day 1), end of intervention (day 5)
Title
Behavioral and Psychological Symptoms of Dementia (BPSD) as Measured by the Cohen-Mansfield Agitation Inventory (CMAI)
Description
Cohen-Mansfield Agitation Inventory (CMAI) is a 29 question scale, each question measured from 1-7. Total score ranges from 29-203 with a higher score indicating a worse outcome. The change in total score between the baseline (day 1) and the end of intervention (day 5) is reported.
Time Frame
baseline (day 1), end of intervention (day 5)
Title
Behavioral and Psychological Symptoms as Assessed by Neuropsychiatric Inventory (NPI)
Description
Neuropsychiatric Inventory (NPI) total score ranges from 0-144, with a higher score indicating greater symptoms. The change in total score between the baseline (day 1) and the end of intervention (day 5) is reported.
Time Frame
baseline (day 1), end of intervention (day 5)
Title
Change in Pain Related Cortical Response Using a Continuous Wave, Multichannel Functional Near-infrared Spectroscopy (fNIRS) Imaging System
Description
Pain-related cortical response will be measured during thermal pain stimulation using a continuous-wave, multichannel fNIRS imaging system (LIGHTNIRS, Shimadzu, Kyoto, Japan) composed of 8 source and 8 detector channels.
fNIRS signals between each source-to-detector pair are analyzed using a general linear model, Y = X*Beta + E , to test for statistical differences between the baseline (day 1) and the end of intervention (day 5).
Y is the measured fNIRS signal, X is an array encoding the expected/hypothetical response, E is an error term, and Beta is interpreted as the strength/amplitude of the functional activation.
Greater absolute Beta values denote that the change in cortical response between two sessions is greater.
The calculated Beta values are expressed in arbitrary units.
Time Frame
baseline (day 1), end of intervention (day 5)
Title
Acceptability as Measured by the tDCs Experience Questionnaire
Description
The tDCS experience questionnaire contains 10 questions based on a scale from 0-10, 0 being strongly disagree and 10 being strongly agree. Higher scores indicating greater acceptability for 7 questions and lower scores indicating greater acceptability for 3 reversed questions. Total score ranges from 0-100 with a most desirable score of a 70.
Time Frame
end of intervention (day 5)
Title
Patient Satisfaction as Measured by the Client Satisfaction Questionnaire (CSQ)
Description
Client Satisfaction Questionnaire (CSQ) consists of 8 questions, each is rated between 1-4. The total score ranges from 8-32 with a higher score indicating a higher satisfaction.
Time Frame
end of intervention (day 5)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
early-stage Alzhimer's disease and related dementias (ADRD)
have caregiver-reported chronic pain (average pain in the past 3 months ≥ 3 out of 10),
have a caregiver willing to participate in the study who sees the participant at least 10 hours/week
can speak and read English
have no plans to change medication regimens during the trial
Exclusion Criteria:
history of brain surgery, brain tumor, seizure, stroke, or intracranial metal implantation
alcohol/substance abuse
severely diminished cognitive function (i.e., MiniMental Status Exam score ≤ 15)
hospitalization within the preceding year for neuropsychiatric illness
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hyochol Ahn, RN,PhD,MSN
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Home-based Transcranial Direct Current Stimulation for Pain Management in Persons With Alzheimer's Disease and Related Dementias
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