Repetitive Transcranial Magnetic Stimulation for Treating Depression: A Functional Magnetic Resonance Imaging Study
8 februari 2019 uppdaterad av: Washington University School of Medicine
Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Major Depressive Disorder: A Functional Connectivity Magnetic Resonance Imaging (fcMRI) Study
This protocol, "Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Major Depressive Disorder (MDD): A Functional Connectivity Magnetic Resonance Imaging (fcMRI) Study," is an open-label pilot treatment study.
The purpose of the present protocol is to treat participants with a diagnosis of Major Depressive Disorder with 4 weeks of rTMS, performing fcMRI and EEG studies prior to and following treatment to determine if treatment response is related to changes in fcMRI and/or EEG results.
The investigators hypothesize that patients who respond to treatment will display changes in functional connectivity patterns thought to be related to the occurrence of depressive symptoms.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Depression is accompanied by rumination that supports inwardly focused cognitive attention on negative events and emotions.
There is evidence to indicate that one aspect of this ruminative behavior lies in an abnormal increase in intra-regional connectivity among elements of the default mode network (DMN).
It is also widely recognized that depression is associated with disturbances of cognition that include deficits in attentional processing, including both reductions in processing speed and deficits in selective attentional processing that are considered a part of executive function.
Thus, there is at least equal reason to believe that attention and executive control networks might show changes in intra-regional functional connectivity.
Given the attentional deficits associated with MDD, we hypothesize that there will be a weakening of intra-network resting state BOLD functional connectivity (rs-fcMRI) in addition to the strengthened connectivity reported by others.Further, we suggest that these shifts in intra-regional connectivity extend to the well-recognized anti-correlated activity between these two networks and support the intrusion of introspective, ruminative thought on cognitive activities that require externally directed attention.
To test this hypothesis, we will use fMRI resting state functional connectivity to examine shifts in network connectivity prior to and following rTMS treatment for depression.
Studietyp
Interventionell
Inskrivning (Faktisk)
4
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Missouri
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Saint Louis, Missouri, Förenta staterna, 63110
- Washington University
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 50 år (Vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
SCREENING/DIAGNOSTIC REQUIREMENTS:
- Male or female outpatients, ages 18-50 (some literature has shown increasing cortical distance with age that may affect treatment outcome
- Hamilton Rating Scale of Depression (HRSD-24) > 18
- New onset major depression or untreated recurrent major depression per DSM-IV-TR38 criteria.
- Not taking antidepressant medication or any other psychotropic medication
- Using an adequate contraceptive method
- Able to give informed consent
- Available for 4 weeks of daily therapy, working hours, Mon.-Fri.
- English-speaking
Exclusion Criteria:
DIAGNOSTIC EXCLUSIONS:
- Co-morbid psychiatric diagnosis of bipolar disorder, acute OCD, schizophrenia or schizoaffective or concurrent treatment with outpatient ECT, or personality disorder or MDD with suicidal ideation as determined by history and/or by P.I. examination requiring hospital admission or referral for acute care.
- Previous failure to respond to treatment with rTMS
- Failure to achieve satisfactory improvement in depression after two or more adequate trials of antidepressant medications.
MEDICAL EXCLUSIONS:
- Patients newly diagnosed with thyroid dysfunction
- History of drug and/or ETOH dependence
- History of seizures
- History of head injury with loss of consciousness > 5 minutes
- Any implantable metal object in the skull or near their head
- Any implantable devices such as a cardiac pacemaker, vagal nerve stimulator, etc.
- Positive urine pregnancy test
- Severe migraine headaches uncontrolled with routine non-narcotic medication
- Any medical condition in the opinion of the Investigator that might confound the results of the study Contraindications to fcMRI procedure
- Intake of NSAIDS, narcotic or muscle relaxants within 72 hours of the fMRI protocol.
- Claustrophobia.
- Left-handedness (may influence cerebral cortical hemispheric dominance).
- Inability to tolerate, or medical contraindication to MRI testing (e.g. metal prostheses or implants, history of claustrophobia)
PROTOCOL SPECIFIC EXCLUSIONS:
- Unable to determine motor threshold for determining treatment dose with rTMS device
- Mini Mental Status Exam (MMSE)70 score < 24.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Grundläggande vetenskap
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: Transcranial Magnetic Stimulation
Open-label transcranial magnetic stimulation
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Four 100-second trains and then one 65-second train, with 30-second inter-train intervals, at 1 Hz and 120% of the resting motor threshold will be applied over the right dorsolateral prefrontal cortex.
Subsequently, twenty-five 30-second trains, with a 30-second inter-train interval, at 10 Hz and 120% of the resting motor threshold will be applied over the left dorsolateral prefrontal cortex.
Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Hamilton Depression Rating Scale-24 Point Version (HDRS-24)
Tidsram: At study entry and within 2 days of exiting 4 weeks of rTMS treatment
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HDRS-24 will be used to measure response to rTMS treatment.
A 50% decrease in HDRS-24 score will indicate treatment response; HDRS-24 < 10 will indicate remission.
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At study entry and within 2 days of exiting 4 weeks of rTMS treatment
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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fCMRI Results
Tidsram: At study entry and within 2 days of exiting 4 weeks of rTMS treatment
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Imaging studies will be compared to determine if any changes in functional connectivity can be correlated with treatment response.
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At study entry and within 2 days of exiting 4 weeks of rTMS treatment
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Huvudutredare: Jose Garcia, MD, Washington University School of Medicine
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- O'Reardon JP, Solvason HB, Janicak PG, Sampson S, Isenberg KE, Nahas Z, McDonald WM, Avery D, Fitzgerald PB, Loo C, Demitrack MA, George MS, Sackeim HA. Efficacy and safety of transcranial magnetic stimulation in the acute treatment of major depression: a multisite randomized controlled trial. Biol Psychiatry. 2007 Dec 1;62(11):1208-16. doi: 10.1016/j.biopsych.2007.01.018. Epub 2007 Jun 14.
- Demitrack MA, Thase ME. Clinical significance of transcranial magnetic stimulation (TMS) in the treatment of pharmacoresistant depression: synthesis of recent data. Psychopharmacol Bull. 2009;42(2):5-38.
- Broyd SJ, Demanuele C, Debener S, Helps SK, James CJ, Sonuga-Barke EJ. Default-mode brain dysfunction in mental disorders: a systematic review. Neurosci Biobehav Rev. 2009 Mar;33(3):279-96. doi: 10.1016/j.neubiorev.2008.09.002. Epub 2008 Sep 9.
- Savitz JB, Drevets WC. Imaging phenotypes of major depressive disorder: genetic correlates. Neuroscience. 2009 Nov 24;164(1):300-30. doi: 10.1016/j.neuroscience.2009.03.082. Epub 2009 Apr 7.
- Zou K, Deng W, Li T, Zhang B, Jiang L, Huang C, Sun X, Sun X. Changes of brain morphometry in first-episode, drug-naive, non-late-life adult patients with major depression: an optimized voxel-based morphometry study. Biol Psychiatry. 2010 Jan 15;67(2):186-8. doi: 10.1016/j.biopsych.2009.09.014.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 januari 2010
Primärt slutförande (Faktisk)
1 september 2013
Avslutad studie (Faktisk)
1 september 2013
Studieregistreringsdatum
Först inskickad
30 november 2009
Först inskickad som uppfyllde QC-kriterierna
13 juli 2010
Första postat (Uppskatta)
14 juli 2010
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
18 februari 2019
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
8 februari 2019
Senast verifierad
1 februari 2019
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- WUSM3621222-201110079
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