Home-based Transcranial Direct Current Stimulation for Pain Management in Persons With Alzheimer's Disease and Related Dementias

Not Applicable

Completed

Conditions: Alzheimer's Disease and Related Dementias

Interventions: Device: Active tDCS
Device: Sham tDCS

Registration Number: NCT04457973

Lead Sponsor: Florida State University

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 40

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active tDCS	Active tDCS	-
Sham tDCS	Sham tDCS	-

Primary Outcome Measures

Name	Time	Method
Pain as Assessed by the Mobilization-Observation-Behavior-Intensity-Dementia (MOBID-2) Scale	baseline (day 1), end of intervention (day 5)	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

Name	Time	Method
Clinical Pain as Assessed by a Numerical Rating Scale (NRS)	baseline (day 1), end of intervention (day 5)	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)	baseline (day 1), end of intervention (day 5)	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)	baseline (day 1), end of intervention (day 5)	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	baseline (day 1), end of intervention (day 5)	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	end of intervention (day 5)	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)	end of intervention (day 5)	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.