Clinical trial NCT04457973: Home-based Transcranial Direct Current Stimulation for Pain Management in Persons With Alzheimer's Disease and Related Dementias
Official title: Home-based Transcranial Direct Current Stimulation (tDCS) for Pain Management in Persons With Alzheimer's Disease and Related Dementias
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer's Disease and Related Dementias
Lead sponsor: Florida State University
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2020-07-07
Enrollment: 40
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Primary outcomes:
measure: Pain as Assessed by the Mobilization-Observation-Behavior-Intensity-Dementia (MOBID-2) Scale
timeFrame: baseline (day 1), end of intervention (day 5)
Secondary outcomes:
measure: Clinical Pain as Assessed by a Numerical Rating Scale (NRS)
timeFrame: baseline (day 1), end of intervention (day 5)
measure: Behavioral and Psychological Symptoms of Dementia (BPSD) as Measured by the Cohen-Mansfield Agitation Inventory (CMAI)
timeFrame: baseline (day 1), end of intervention (day 5)
measure: Behavioral and Psychological Symptoms as Assessed by Neuropsychiatric Inventory (NPI)
timeFrame: baseline (day 1), end of intervention (day 5)
measure: Change in Pain Related Cortical Response Using a Continuous Wave, Multichannel Functional Near-infrared Spectroscopy (fNIRS) Imaging System
timeFrame: baseline (day 1), end of intervention (day 5)
measure: Acceptability as Measured by the tDCs Experience Questionnaire
timeFrame: end of intervention (day 5)
measure: Patient Satisfaction as Measured by the Client Satisfaction Questionnaire (CSQ)
timeFrame: end of intervention (day 5)
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Hyochol Ahn, RN,PhD,MSN
role: PRINCIPAL_INVESTIGATOR
References: