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

Florida State University logo

Florida State University

Status

Completed

Conditions

Alzheimer's Disease and Related Dementias

Treatments

Device: Sham tDCS
Device: Active tDCS

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT04457973
R15NR018050 (U.S. NIH Grant/Contract)
HSC-SN-20-0640

Details and patient eligibility

About

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.

Enrollment

40 patients

Sex

All

Ages

50 to 90 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

40 participants in 2 patient groups, including a placebo group

Active tDCS
Experimental group
Treatment:
Device: Active tDCS
Sham tDCS
Placebo Comparator group
Treatment:
Device: Sham tDCS

Trial documents
2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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