Home-based Transcranial Direct Current Stimulation for Pain Management in Persons with Alzheimers Disease
Home-based Transcranial Direct Current Stimulation for Pain Management in Persons with Alzheimers Disease
批准号:
10120073
负责人:
Kenneth B Mathis
金额:
$15.43万
依托单位国家:
美国
项目类别:
财政年份:
2019
资助国家:
美国
项目状态:
已结题
起止时间:
2019-08-01 至 2022-07-31
关键词:
AddressAdverse effectsAffectAgitationAlzheimer&aposs DiseaseAmericanAnalgesicsAnodesAreaBehavior DisordersBehavioral SymptomsBlindedBrainCaregiversCathodesChronicClinicClinicalClinical TrialsCognitiveConfusionConstipationContralateralDataDementiaDevelopmentDevicesElderlyEnsureEquipment and supply inventoriesFutureGoalsHealth ExpendituresHome environmentIndividualInterventionInvestigationKnee OsteoarthritisMemoryModalityMorbidity - disease rateMotor CortexNear-Infrared SpectroscopyPainPain managementPainlessParentsParticipantPatientsPersonsPharmaceutical PreparationsPharmacologyPhasePopulationPrevalencePublic HealthQuality of lifeRandomizedRandomized Clinical TrialsResearchResearch TrainingRiskSecureSelf AdministrationSupervisionSystemTechniquesTestingUnited StatesUnited States Food and Drug AdministrationVideoconferencingbasebehavior observationchronic painclinical paincomorbiditydesignevidence based guidelinesexperiencefallshemodynamicsimprovedinnovationinsightinterestnovelosteoarthritis painpain processingpain reductionpsychological symptomreal time monitoringresponseside effectstandard of caresymptom managementtool
中文摘要
摘要
英文摘要
ABSTRACT
This Alzheimer’s-focused supplement will investigate the effects of home-based, remotely supervised
transcranial direct current stimulation (tDCS) for pain management in persons with Alzheimer's disease (AD).
The research proposed in this supplement aligns with the parent study (R15NR018050). The long-term goal of
this supplement study is to improve pain management using home-based nonpharmacological approaches. AD
is the most prevalent type of dementia, affecting 5.5 million individuals in the United States, and the
management of pain is challenging because existing pharmacological approaches often produce significant
adverse effects (e.g., constipation, confusion, behavioral disorders, psychomotor retardation, and falls). Also,
recent evidence suggests that alterations in pain-related brain mechanisms may contribute to chronic pain.
Therefore, innovative nonpharmacological interventions targeting pain-related brain function in persons with
AD are needed. One promising pain treatment is tDCS with the anode over the primary motor cortex (M1) and
the cathode over the contralateral supraorbital area (SO), as it can change brain activity in a noninvasive,
painless, and safe way. tDCS is categorized by the FDA as a “non-significant risk” device. Moreover, home-
based tDCS has been safely used to improve cognitive or memory problems among persons with AD and
other dementias. However, no investigations to date have examined whether home-based tDCS can reduce
pain. Home-based interventions are critical because persons with AD have difficulty attending clinic-based
sessions over several days, and recent technological advances have created the potential for home
interventions with real-time monitoring through a secure videoconferencing platform. The central hypothesis is
that home-based, remotely supervised tDCS will decrease pain. This hypothesis will be tested by pursuing the
following specific aims: evaluate the preliminary effects of home-based M1-SO applied tDCS on clinical pain in
persons with early-stage AD (specific aim 1); evaluate the preliminary effects of home-based M1-SO applied
tDCS on pain-related cortical response in persons with early-stage AD (specific aim 2); and evaluate the
feasibility and acceptability of home-based M1-SO–applied tDCS for pain management in persons with early-
stage AD (specific aim 3). We will also obtain data, as an exploratory aim, to investigate whether tDCS reduces
behavioral and psychological symptoms of dementia. The proposed study will directly investigate the effects of
home-based, remotely supervised tDCS in 40 persons with AD using an experimenter- and participant-blinded,
randomized, sham-controlled, parallel group (1:1 for two groups) pilot clinical trial. Caregivers will set up and
administer tDCS for persons with AD at home, and participants will be remotely supervised by trained research
staff at each stimulation to ensure the use of proper technique. The proposed research is significant because it
is expected to provide valuable insight into an exciting new modality of nonpharmacological pain management
that is easy, safe, and noninvasive with minimal side effects.
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