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- Sperimentazione clinica NCT06236711
Stimolazione transcranica a corrente continua (tDCS) come trattamento aggiuntivo per la depressione resistente al trattamento (TRD)
Uno studio di fattibilità della stimolazione transcranica a corrente continua (tDCS) come trattamento aggiuntivo per la depressione resistente al trattamento (TRD) nei pazienti ospedalizzati
The researchers are trying to test the feasibility and acceptability of using transcranial Direct Current Stimulation (tDCS) in hospitalized adult patients with Treatment Resistant Depression (TRD), assess for any preliminary effect on depressive and cognitive symptoms, and explore the utility of biomarkers to assess response to tDCS.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
In this feasibility study the researchers propose to conduct a 5-day tDCS treatment protocol in hospitalized adult patients with TRD, with each treatment session lasting for 30 minutes, delivered twice daily, for a total of 10 stimulations over 5 days. Before and after the 5-day tDCS treatment protocol, assessments will include Montgomery-Asberg Depression Rating Scale (MADRS) to measure depressive symptoms, Snaith-Hamilton Pleasure Scale (SHAPS) to measure anhedonia, Stroop Test to measure memory and executive function, Revised Hopkins Verbal Learning Test (HVLT-R) to test verbal learning and memory, and Digital Symbol Coding Test (DSCT) to measure working memory. Electroencephalography (EEG) for objective electrophysiologic data will also be collected before and after tDCS. A wireless EEG unit (CGX, Cognionic, Inc.) will be used to collect EEG and peak alpha frequency (PAF) as potential target engagement marker for tDCS. The PAF measures the highest magnitude within the alpha range of brain oscillations, thought to reflect cognitive performance. Other potential predictors of treatment response measures collected at baseline include Adverse Childhood Experiences (ACE), premorbid intelligence quotient (pIQ), Wide Range Achievement Reading Test (WRART), and Socioeconomic Status (SES).
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Minnesota
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Rochester, Minnesota, Stati Uniti, 55905
- Mayo Clinic in Rochester
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria
- 18 years and older
- Clinical diagnosis of treatment-resistant depression (defined as depression that does not remit following two or more treatment attempts of an adequate dose and duration of a minimum duration of 4 weeks)
- Hospitalized in psychiatric units
- Voluntary admission status
- Moderate or severe depression, defined by PHQ-9 ≥ 15
- Ability to provide informed consent
- Ability to adhere to protocol
Exclusion Criteria
- Bipolar disorder
- Active primary psychotic or substance use disorders (except nicotine dependence) within the past year
- Any active neurological condition (including seizure disorder, traumatic brain injury, stroke)
- Contraindications to tDCS (including pacemaker, metallic implants in the head or neck [except orthodontic hardware], skin disease causing irritation)
- Current pregnancy or positive urine pregnancy test (clinical)
- Any neuromodulation therapy (including ECT, rTMS, DBS, VNS, TES) within the last 3 months
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Fattibilità del dispositivo
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: tDCS interventional arm
Participants will receive a 30-minute tDCS treatments at 2 mA twice daily over the course of 5 days. |
tDCS is a form of noninvasive transcranial stimulation of the brain by delivering low-intensity electrical current to the scalp through two electrodes. The Soterix Medical 1×1 Low Intensity Transcranial DC Stimulator Model 1300A (Soterix Medical, Inc., New York, NY, USA) device will be used in the study. The tDCS device is comprised of a small battery-operated control box that delivers the current through electrodes placed on the scalp, held in place by elastic bands or head straps and worn over the forehead like a headband. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Feasibility outcome
Lasso di tempo: through study completion, an average of 2 weeks
|
Defined as 70% of eligible patients choosing to enroll in the study. Other feasibility parameters will include willingness of clinicians to refer and help recruit patients, number of eligible participants, willingness of participants to enroll, retention of patients, and completeness of data collection. |
through study completion, an average of 2 weeks
|
|
Acceptability outcome
Lasso di tempo: through study completion, an average of 2 weeks
|
Defined as 80% of study participants completing 80% of the 10-session tDCS treatment protocol. Investigators will also ask participants about their satisfaction, perceptions, and experiences with the tDCS treatments. Other acceptability parameters will include rates of adherence to tDCS protocol, dropout rates and reasons for non-completion. |
through study completion, an average of 2 weeks
|
|
Tolerability outcome
Lasso di tempo: through study completion, an average of 2 weeks
|
Defined as an overall tolerability rating of "very tolerable." This will be a self-report based on a global question "Considering all aspects of your experience, how would you rate the overall tolerability of the tDCS intervention?" The response options are: very tolerable, somewhat tolerable, neutral, somewhat intolerable, and very intolerable. Other tolerability parameters will include the tDCS adverse effects questionnaire. |
through study completion, an average of 2 weeks
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in Montgomery-Asberg Depression Rating Scale (MADRS)
Lasso di tempo: baseline, 2 weeks
|
Measure of depressive symptoms. Response is defined by a 50% or more reduction in MADRS score. The MADRS has 10-items which are based on mood symptoms. Each items is scored 0 (normal) to 6 (severe depression) with overall score ranges from 0 (normal) to 60 (severe depression). |
baseline, 2 weeks
|
|
Change in Snaith-Hamilton Pleasure Scale (SHAPS)
Lasso di tempo: baseline, 2 weeks
|
Measure of anhedonia. The SHAPS has 14-items which are based on pleasure symptoms. Each item is scored 1 (definitely agree) to 4 (definitely disagree) with overall score ranges from 14 (experience high pleasure) to 56 (experience low pleasure) |
baseline, 2 weeks
|
|
Change in Stroop Test
Lasso di tempo: baseline, 2 weeks
|
Measure of measure memory and executive function. Reaction time (in seconds) in the different conditions of the task (reading the non-conflicting condition, reading the conflicting condition) |
baseline, 2 weeks
|
|
Change in Revised Hopkins Verbal Learning Test (HVLT-R)
Lasso di tempo: baseline, 2 weeks
|
Measure of verbal learning and memory. The HVLT-R has 12-items which are based on memory score. Total recall score (range from 0 to 36). The higher the score indicates better short-term memory, lowers scores indicates worse short-term memory. |
baseline, 2 weeks
|
|
Change in Digital Symbol Coding Test (DSCT)
Lasso di tempo: baseline, 2 weeks
|
Measure of working memory. The DSST involves a key consisting of the numbers 1-9, each paired with a unique, easy to draw symbol. Below the key are a series of numbers that 1-9 in random order and repeated several times, that are to be filled in the corresponding symbol for each number. One point is given for each correct response. Total scores range from 0-9, lower scores indicate worse memory; higher scores indicate better memory. |
baseline, 2 weeks
|
|
Change in Peak alpha frequency (PAF)
Lasso di tempo: baseline, 2 weeks
|
EEG measure of the highest magnitude within the alpha range of brain oscillations, thought to reflect cognitive performance. |
baseline, 2 weeks
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Maria I Lapid, MD, Mayo Clinic
Pubblicazioni e link utili
Collegamenti utili
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Disordini mentali
- Disturbi dell'umore
- Disordine depressivo
- Disturbo depressivo, resistente al trattamento
- Terapie
- Discipline e attività comportamentali
- Terapia di stimolazione elettrica
- Terapia convulsiva
- Terapie somatiche psichiatriche
- Elettroshock
- Tecniche psicologiche
- Stimolazione transcranica di corrente continua
Altri numeri di identificazione dello studio
- 23-003274
Piano per i dati dei singoli partecipanti (IPD)
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