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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 50 Years and 90 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Care Provider)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Active tDCS
  • 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.
Placebo Comparator
Sham tDCS
  • Device: 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.

More Details

Status
Completed
Sponsor
Florida State University

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.