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

Alzheimer's Disease and Related Dementias Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04457973
• Other study ID #: HSC-SN-20-0640
• Secondary ID: R15NR018050
• Status: Completed
• Phase: N/A
• Start date: September 4, 2020
• Est. completion date: October 19, 2022

Study information

• Verified date: September 2023
• Source: Florida State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 19, 2022
• Est. primary completion date: October 19, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease and Related Dementias
• Dementia

Intervention

Device:
• Active tDCS
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.
• Sham tDCS
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.

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Florida State University	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	baseline (day 1), end of intervention (day 5)
Secondary	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.	baseline (day 1), end of intervention (day 5)
Secondary	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.	baseline (day 1), end of intervention (day 5)
Secondary	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.	baseline (day 1), end of intervention (day 5)
Secondary	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.	baseline (day 1), end of intervention (day 5)
Secondary	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.	end of intervention (day 5)
Secondary	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.	end of intervention (day 5)