N/A
Completed N=40
Home-based Transcranial Direct Current Stimulation for Pain Management in Persons With Alzheimer's Disease and Related Dementias
Source: ClinicalTrials.gov NCT04457973 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Oct 2023
Primary outcomePrimary: Pain as Assessed by the Mobilization-Observation-Behavior-Intensity-Dementia (MOBID-2) Scale — -2.70; -.40 score on a scale
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.
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 | — |
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
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. Informational only — not medical advice.