Low Field Magnetic Stimulation in Mood Disorders Using the LFMS Device (LFMS)
12 aprile 2016 aggiornato da: Michael Rohan, Mclean Hospital
This study is designed to test whether low-field magnetic stimulation (LFMS) can relieve some of the symptoms of depression in bipolar disorder or major depression.
Panoramica dello studio
Stato
Completato
Intervento / Trattamento
Descrizione dettagliata
This study involves a screening visit with the study physician and a treatment visit.
Participants will be asked to complete several questionnaires about their mood during both visits.
The treatment visit will involve use of the LFMS device.
Participants will place the top of their head inside the device for approximately 20 minutes.
Participants will receive either the actual treatment or a sham treatment and will not know which they receive.
This device produces weak electromagnetic fields.
There is no discomfort or even sensation caused by the device.
The device has been declared to be a "non-significant risk device" by the FDA, and there are no known risks associated with its use.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
107
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
-
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Massachusetts
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Belmont, Massachusetts, Stati Uniti, 02478
- McLean Hospital
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 18 anni a 70 anni (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
Inclusion Criteria:
- Diagnosis of Major Depressive Disorder or Bipolar Disorder; must be currently depressed
- May be medicated or unmedicated
Exclusion Criteria:
- Contraindication for MRI due to metal in eyes/head
- Claustrophobia.
- Inability to lie flat.
- History of brain injury.
- Pregnant
- Current drug use/abuse/dependence
- History of polysubstance use
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Quadruplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Comparatore fittizio: Sham (inactive) Treatment BPD
20 minutes of sham treatment with the Low Field Magnetic Stimulation Device (LFMS)in bipolar depressed subjects
|
The LFMS Device is an electromagnetic coil situated on a cylinder with an inside diameter of 13.2 inches.
It produces weak electromagnetic fields at a frequency of about 1 kHz; the magnetic fields are less than 30 Gauss and the electric fields are up to 1.43 V/m.
Subjects will receive one 20 minute treatment.
Altri nomi:
|
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Comparatore attivo: Active LFMS treatment in BPD
20 minutes of active treatment with the Low Field Magnetic Stimulation Device (LFMS)in bipolar depressed subjects
|
The LFMS Device is an electromagnetic coil situated on a cylinder with an inside diameter of 13.2 inches.
It produces weak electromagnetic fields at a frequency of about 1 kHz; the magnetic fields are less than 30 Gauss and the electric fields are up to 1.43 V/m.
Subjects will receive one 20 minute treatment.
Altri nomi:
|
|
Comparatore fittizio: Sham LFMS Comparator: in MD
20 minutes of sham treatment with the Low Field Magnetic Stimulation Device (LFMS) in major depressed subjects
|
The LFMS Device is an electromagnetic coil situated on a cylinder with an inside diameter of 13.2 inches.
It produces weak electromagnetic fields at a frequency of about 1 kHz; the magnetic fields are less than 30 Gauss and the electric fields are up to 1.43 V/m.
Subjects will receive one 20 minute treatment.
Altri nomi:
|
|
Comparatore attivo: Experimental LFMS: in MD
20 minutes of active treatment with the Low Field Magnetic Stimulation Device (LFMS) in major depressed subjects
|
The LFMS Device is an electromagnetic coil situated on a cylinder with an inside diameter of 13.2 inches.
It produces weak electromagnetic fields at a frequency of about 1 kHz; the magnetic fields are less than 30 Gauss and the electric fields are up to 1.43 V/m.
Subjects will receive one 20 minute treatment.
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Mean Change in Hamilton Depression Rating Scale (HAM-D) (17 Item) in Subjects With Bipolar Depression
Lasso di tempo: Once just before and once just after treatment
|
A multiple choice questionnaire used to rate depression severity.
Mean change from pretreatment score.
17 items reflecting depression symptoms are scored on scale of severity; 9 items are scored 0 = Absent 1 = Trivial 2 = Mild 3 = Moderate 4 = Severe 8 items are scored 0 = Absent 1 = Mild 2 = Severe.
Items are summed; minimum score is 0, maximum score is 52.
Higher scores represent more severe depression.
|
Once just before and once just after treatment
|
|
Mean Change in Hamilton Depression Depression Rating Scale (HAM-D) (17 Item) in Subjects With Major Depressive Disorder
Lasso di tempo: Once just before and once just after treatment
|
A multiple choice questionnaire used to rate depression severity.
Mean change from pretreatment score.
17 items reflecting depression symptoms are scored on scale of severity; 9 items are scored 0 = Absent 1 = Trivial 2 = Mild 3 = Moderate 4 = Severe 8 items are scored 0 = Absent 1 = Mild 2 = Severe.
Items are summed; minimum score is 0, maximum score is 52.
Higher scores represent more severe depression.
|
Once just before and once just after treatment
|
|
Visual Analog Scale (VAS) in Subjects With Bipolar Depression
Lasso di tempo: Once just before and once just after treatment
|
Eleven point Likert scales indicating immediate depression state.
Mean change from pretreatment score.
Participant marks an 'X' on a numbered line anchored by 0 = no depression and 10 = most depressed ever been.
|
Once just before and once just after treatment
|
|
Visual Analog Scale (VAS) in Subjects With Major Depressive Disorder
Lasso di tempo: Once just before and once just after treatment
|
Eleven point Likert scales indicating immediate depression state.
Mean change from pretreatment score.
Participant marks an 'X' on a numbered line anchored by 0 = no depression and 10 = most depressed ever been.
|
Once just before and once just after treatment
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Mean Change in Hamilton Depression Rating Scale (HAM-D) (17 Item): Combined Diagnostic Groups.
Lasso di tempo: Once just before and once just after treatment
|
A multiple choice questionnaire used to rate depression severity.
Mean change from pretreatment score.
17 items reflecting depression symptoms are scored on scale of severity; 9 items are scored 0 = Absent 1 = Trivial 2 = Mild 3 = Moderate 4 = Severe 8 items are scored 0 = Absent 1 = Mild 2 = Severe.
Items are summed; minimum score is 0, maximum score is 52.
Higher scores represent more severe depression.
|
Once just before and once just after treatment
|
|
Visual Analog Scale (VAS): Combined Diagnostic Groups.
Lasso di tempo: Once just before and once just after treatment
|
Eleven point Likert scales indicating immediate depression state.
Mean change from pretreatment score.
Participant marks an 'X' on a numbered line anchored by 0 = no depression and 10 = most depressed ever been.
|
Once just before and once just after treatment
|
|
Positive and Negative Affect Schedule (PANAS) Positive Score: Combined Diagnostic Group.
Lasso di tempo: Once just before and once just after treatment
|
20 item list of words that describe different feelings and emotions with positive and negative valences (10 each), which the subject scores on a 1-5 scale: 1 = very slightly or not at all 2 = a little 3 = moderate 4 = quite a bit 5 = extremely.
Positive and Negative scores are calculated and reported separately and range from 10-50.
Higher positive score reflects stronger positive affect and higher negative score reflects stronger negative affect.
|
Once just before and once just after treatment
|
|
Positive and Negative Affect Schedule (PANAS) Negative Score: Combined Diagnostic Group.
Lasso di tempo: once pre and once post LFMS treatment
|
20 item list of words that describe different feelings and emotions with positive and negative valences (10 each), which the subject scores on a 1-5 scale: 1 = very slightly or not at all 2 = a little 3 = moderate 4 = quite a bit 5 = extremely.
Positive and Negative scores are calculated and reported separately and range from 10-50.
Higher positive score reflects stronger positive affect and higher negative score reflects stronger negative affect.
|
once pre and once post LFMS treatment
|
|
Positive and Negative Affect Schedule (PANAS) Positive Score in Subjects With Bipolar Depression.
Lasso di tempo: Once just before and once just after treatment
|
20 item list of words that describe different feelings and emotions with positive and negative valences (10 each), which the subject scores on a 1-5 scale: 1 = very slightly or not at all 2 = a little 3 = moderate 4 = quite a bit 5 = extremely.
Positive and Negative scores are calculated and reported separately and range from 10-50.
Higher positive score reflects stronger positive affect and higher negative score reflects stronger negative affect.
|
Once just before and once just after treatment
|
|
Positive and Negative Affect Schedule (PANAS) Positive Score in Subjects With Major Depressive Disorder
Lasso di tempo: Once just before and once just after treatment
|
20 item list of words that describe different feelings and emotions with positive and negative valences (10 each), which the subject scores on a 1-5 scale: 1 = very slightly or not at all 2 = a little 3 = moderate 4 = quite a bit 5 = extremely.
Positive and Negative scores are calculated and reported separately and range from 10-50.
Higher positive score reflects stronger positive affect and higher negative score reflects stronger negative affect.
|
Once just before and once just after treatment
|
|
Positive and Negative Affect Schedule (PANAS) Negative Score in Subjects With Bipolar Depression
Lasso di tempo: once pre and once post LFMS treatment
|
20 item list of words that describe different feelings and emotions with positive and negative valences (10 each), which the subject scores on a 1-5 scale: 1 = very slightly or not at all 2 = a little 3 = moderate 4 = quite a bit 5 = extremely.
Positive and Negative scores are calculated and reported separately and range from 10-50.
Higher positive score reflects stronger positive affect and higher negative score reflects stronger negative affect.
|
once pre and once post LFMS treatment
|
|
Positive and Negative Affect Schedule (PANAS) Negative Score in Subjects With Major Depressive Disorder
Lasso di tempo: once pre and once post LFMS treatment
|
20 item list of words that describe different feelings and emotions with positive and negative valences (10 each), which the subject scores on a 1-5 scale: 1 = very slightly or not at all 2 = a little 3 = moderate 4 = quite a bit 5 = extremely.
Positive and Negative scores are calculated and reported separately and range from 10-50.
Higher positive score reflects stronger positive affect and higher negative score reflects stronger negative affect.
|
once pre and once post LFMS treatment
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Michael Rohan, PhD, McLean Hospital
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- Carlezon WA Jr, Rohan ML, Mague SD, Meloni EG, Parsegian A, Cayetano K, Tomasiewicz HC, Rouse ED, Cohen BM, Renshaw PF. Antidepressant-like effects of cranial stimulation within a low-energy magnetic field in rats. Biol Psychiatry. 2005 Mar 15;57(6):571-6. doi: 10.1016/j.biopsych.2004.12.011.
- Rohan M, Parow A, Stoll AL, Demopulos C, Friedman S, Dager S, Hennen J, Cohen BM, Renshaw PF. Low-field magnetic stimulation in bipolar depression using an MRI-based stimulator. Am J Psychiatry. 2004 Jan;161(1):93-8. doi: 10.1176/appi.ajp.161.1.93.
- Rohan ML, Yamamoto RT, Ravichandran CT, Cayetano KR, Morales OG, Olson DP, Vitaliano G, Paul SM, Cohen BM. Rapid mood-elevating effects of low field magnetic stimulation in depression. Biol Psychiatry. 2014 Aug 1;76(3):186-93. doi: 10.1016/j.biopsych.2013.10.024. Epub 2013 Nov 12.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 novembre 2007
Completamento primario (Effettivo)
1 marzo 2011
Completamento dello studio (Effettivo)
1 marzo 2013
Date di iscrizione allo studio
Primo inviato
18 dicembre 2007
Primo inviato che soddisfa i criteri di controllo qualità
18 dicembre 2007
Primo Inserito (Stima)
21 dicembre 2007
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
16 maggio 2016
Ultimo aggiornamento inviato che soddisfa i criteri QC
12 aprile 2016
Ultimo verificato
1 aprile 2016
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 2006-P-001655
- Stanley Grant 07TGS-1045 (Altro numero di sovvenzione/finanziamento: Stanley Grant 07TGS-1045)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .