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

NCT ID: NCT04457973

Last Updated: 2023-10-13

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-04

Study Completion Date

2022-10-19

Brief Summary

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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.

Detailed Description

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Conditions

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Alzheimer's Disease and Related Dementias

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Active tDCS

Group Type EXPERIMENTAL

Active tDCS

Intervention Type DEVICE

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.

Sham tDCS

Group Type PLACEBO_COMPARATOR

Sham tDCS

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Nursing Research (NINR)

NIH

Sponsor Role collaborator

Florida State University

OTHER

Sponsor Role lead

Responsible Party

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Hyochol Ahn, PhD

Associate Dean for Research & Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hyochol Ahn, RN,PhD,MSN

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

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The University of Texas Health Science Center at Houston

Houston, Texas, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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HSC-SN-20-0640

Identifier Type: -

Identifier Source: org_study_id

R15NR018050

Identifier Type: NIH

Identifier Source: secondary_id

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