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NCT Number: NCT04457973

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

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.

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Key information

Conditions

Alzheimer's Disease and Related Dementias Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

50 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

active tDCS

Device

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

Device

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 outcomes

  1. Pain as Assessed by the Mobilization-Observation-Behavior-Intensity-Dementia (MOBID-2) Scale

    Time frame: 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 outcomes

  1. Clinical Pain as Assessed by a Numerical Rating Scale (NRS)

    Time frame: 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.

  2. Behavioral and Psychological Symptoms of Dementia (BPSD) as Measured by the Cohen-Mansfield Agitation Inventory (CMAI)

    Time frame: 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.

  3. Behavioral and Psychological Symptoms as Assessed by Neuropsychiatric Inventory (NPI)

    Time frame: 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.

  4. Change in Pain Related Cortical Response Using a Continuous Wave, Multichannel Functional Near-infrared Spectroscopy (fNIRS) Imaging System

    Time frame: 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.

  5. Acceptability as Measured by the tDCs Experience Questionnaire

    Time frame: 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.

  6. Patient Satisfaction as Measured by the Client Satisfaction Questionnaire (CSQ)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Florida State University

Other

Collaborators

  • National Institute of Nursing Research (NINR)

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jul 7, 2020
Registry last updated
Oct 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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