Transcranial Magnetic Stimulation for the Treatment of Veterans with Alcohol Use Disorders
Transcranial Magnetic Stimulation for the Treatment of Veterans with Alcohol Use Disorders
批准号:
10306328
负责人:
TIMOTHY CRAIG DURAZZO
金额:
$0.0万
依托单位国家:
美国
项目类别:
财政年份:
2017
资助国家:
美国
项目状态:
已结题
起止时间:
2017-12-01 至 2024-09-30
关键词:
AbstinenceAddressAlcohol consumptionAnteriorAnxietyBiological MarkersBlood flowBrainBrain regionChronicCigaretteClinicCognitiveConsumptionControlled Clinical TrialsControlled StudyDataDiseaseDouble-Blind MethodFDA approvedFrequenciesFunctional disorderFutureGlutamatesGlutamineGoalsHealthHealth Care CostsHealthcare SystemsHigh PrevalenceHomelessnessInterventionLeftMagnetic Resonance ImagingMajor Depressive DisorderMeasurementMeasuresMedicalMethodsModalityMonitorMoodsNeurobiologyNeurocognitive DeficitNeuropsychologyOutcome MeasureParticipantPersonsPharmacologyProceduresProtocols documentationRandomized Clinical TrialsRecoveryRecovery of FunctionRelapseResearchResource AllocationSamplingSeveritiesTechniquesTelephoneTherapeuticTissuesTranscranial magnetic stimulationTreatment ProtocolsTreatment outcomeUnemploymentUnited States Department of Veterans AffairsVeteransalcohol abuse therapyalcohol use disordercigarette smokingclinically relevantcostcravingdepressive symptomsdesigneffective therapyeffectiveness evaluationefficacy evaluationexperiencefrontal lobeinnovationnovelpotential biomarkerpsychosocialrecruitrepetitive transcranial magnetic stimulationresearch studysobrietysocial relationshipsstandardize measuresubstance abuse treatmentsubstance usetreatment grouptreatment response
中文摘要
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英文摘要
The purpose of this study is to evaluate the efficacy of repetitive transcranial magnetic stimulation (rTMS)
as a treatment for Veterans with an alcohol use disorder (AUD) to decrease the exceedingly high rate of
relapse associated with this condition.
At least 60% of those with AUD will experience a major relapse period within 6 months of treatment,
irrespective of the intervention (psychosocial and/or pharmacological) employed. Consequently, the high
prevalence of AUD and relapse following treatment in Veterans is associated with substantial resource
allocation and costs for the DVA Health Care System. Current pharmacological and psychosocial interventions
demonstrate only a moderate level of efficacy, which is reflected in the high rate of relapse in AUD.
rTMS is a neurostimulation method that is at the forefront of innovative, non-invasive, and safe treatments
for AUD, and the disorders that commonly co-occur with AUD. To reduce the high rate of relapse in Veterans
with AUD, it is necessary for interventions to more effectively address the associated neurobiological
dysfunction and salient co-occurring conditions. Accordingly, additional rigorously controlled studies are
required to determine if rTMS is an effective treatment for Veterans with AUD.
Participants will be recruited from VA Palo Alto Health Care System (VAPAHCS) residential substance
abuse treatment clinics A double-blind randomized clinical trial with two groups: Active rTMS Treatment Group
(Active rTMS) – will receive four to five treatments (two treatments per day) each week for 2 weeks. Sham
Control Treatment group (i.e., identical rTMS experimental procedure, but no active stimulation) will receive the
same frequency and duration of rTMS sessions. The proposed rTMS protocol is consistent with the FDA
approved treatment regimen employed for major depressive disorders at the VAPAHCS MIRECC. Magnetic
resonance imaging (MR) will be completed prior to rTMS treatment and used to localize the left DLPFC in each
participant to optimize rTMS for this region. Active and Sham rTMS groups will complete predictive measures
[i.e., MR measures of anterior frontal glutamate:glutamine ratio (Glx), blood flow and tissue volume] prior to the
inception of rTMS treatment (baseline) and other outcome measures (i.e., measures of craving, mood, anxiety)
immediately pre- and post-completion of the 2 weeks of rTMS sessions. Measurement of baseline anterior
frontal Glx, blood flow levels, and tissue volumes is necessary to establish potential biomarkers for prediction
of rTMS treatment response, which is requisite for therapeutic optimization. For the 6 months following
completion of active or sham rTMS treatment, participants will be contacted monthly, via telephone or in
person, to complete a brief standardized measure of alcohol and substance use, as well as craving, to assess
for changes in these variables over the previous 30 days.
This project will deliver completely novel data on the efficacy of rTMS for Veterans with AUD during the first
6 months following treatment. Monitoring over the entire first 6 months following treatment is crucial, given
relapse within the first 6 months of treatment is robustly related to poor psychosocial functioning over the
ensuing 1-3 years. The ultimate goal of this proposal is provide treatment that more effectively promotes
sustained abstinence in the Veteran with AUD, as extended abstinence is robustly associated with optimum
biomedical, neuropsychological, psychiatric, and psychosocial recovery and functioning.
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会议论文
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负责人:TIMOTHY CRAIG DURAZZO
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依托单位:
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资助金额:$16.16万
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依托单位:
海外基金