N/A N=40 Randomized Double-blind Treatment

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

Alzheimer's Disease and Related Dementias

Bottom Line

View on ClinicalTrials.gov: NCT04457973 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2023

Primary outcome: Primary: Pain as Assessed by the Mobilization-Observation-Behavior-Intensity-Dementia (MOBID-2) Scale — -2.70; -.40 score on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Active tDCS (Device); Sham tDCS (Device)
Age: Adult, Older Adult · 50+ yrs
Sex: All
Sponsor: Florida State University
Primary completion: Oct 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Pain as Assessed by the Mobilization-Observation-Behavior-Intensity-Dementia (MOBID-2) Scale	-2.70; -.40	—
SECONDARY Clinical Pain as Assessed by a Numerical Rating Scale (NRS)	-13.55; -3.30	—
SECONDARY Behavioral and Psychological Symptoms of Dementia (BPSD) as Measured by the Cohen-Mansfield Agitation Inventory (CMAI)	-2.35; -2.95	—
SECONDARY Behavioral and Psychological Symptoms as Assessed by Neuropsychiatric Inventory (NPI)	-2.9; -2.30	—
SECONDARY Change in Pain Related Cortical Response Using a Continuous Wave, Multichannel Functional Near-infrared Spectroscopy (fNIRS) Imaging System	-6.39; -5.30; 2.31; -4.64; -3.60; 3.13	—
SECONDARY Acceptability as Measured by the tDCs Experience Questionnaire	62.05; 67.95	—
SECONDARY Patient Satisfaction as Measured by the Client Satisfaction Questionnaire (CSQ)	28.75; 28.55	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04457973). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.