- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02839798
NeoSync TMS Treatment for Bipolar I Depression (NESTTBID)
31 mars 2020 uppdaterad av: Linda L Carpenter MD, Butler Hospital
Evaluation of NeoSync EEG Synchronized TMS For the Treatment of Major Depressive Episode in Bipolar Disorder and Associated Neural Response: An Open Label Trial
This study is designed to evaluate the safety and preliminary efficacy of synchronized transcranial magnetic stimulation (sTMS) using the NeoSync EEG Synchronized TMS device (NEST) in subjects with Bipolar Disorder type I in a Major Depressive Episode.
This is an open label study in which subjects will receive treatment 5 days per week for 6 weeks.
Studieöversikt
Status
Avslutad
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
6
Fas
- Fas 2
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Rhode Island
-
Providence, Rhode Island, Förenta staterna, 02906
- Butler Hospital
-
-
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 70 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria: Subjects must meet all of the following inclusion criteria to qualify for enrollment into the study:
- 18 - 70 years of age;
- DSM-5 primary diagnosis of Bipolar Disorder type 1 (with a documented past manic episode), currently in a Major Depressive Episode by diagnostic criteria elicited by structured clinical interview (SCID-5-RV);
- MADRS score ≥ 20;
- Duration of current episode >4 weeks
- YMRS score ≤ 12;
- baseline EEG of sufficient quality for quantitative analysis processing;
- willing and able to adhere to the intensive treatment schedule and all required study visits;
- currently on adequate dose of mood stabilizer with significant evidence base or FDA approval as antimanic or for maintenance therapy of bipolar disorder (e.g, valproic acid/divalproex, carbamazepine, lithium, aripiprazole, ziprasidone, risperidone, quetiapine, olanzapine, asenapine, haloperidol, chlorpromazine, paliperidone, cariprazine).
Exclusion Criteria: Subjects will be excluded from study participation if one of the following exclusion criteria applies:
- unable or unwilling to give informed consent;
- diagnosed with current primary psychotic disorder (rather than BD);
- diagnosed with current mania or hypomanic mood episode;
- history of moderate to severe substance use disorder within the past 6 months (except nicotine and caffeine);
- currently being treated with a stimulant;
- clinically defined major neurological disorder; including, but not limited to, seizure disorder and history of loss of consciousness due to head injury for greater than 10 minutes, or with documented evidence of brain injury;
- increased risk of seizure for any reason, including diagnosis of increased intracranial pressure, comorbid neurological disorder, use of certain medications, highly unstable use of alcohol or benzodiazepines;
- initiation of new antidepressant treatments (new medication, new device-based stimulation, or new psychotherapy) within 6 weeks prior to study baseline;
- active suicidal intent or plan as detected on screening assessments, or in the Investigator's opinion, is likely to attempt suicide within the next six months;
- presence of implanted cardiac pacemakers, implanted medication pumps, or intracardiac lines;
- intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear implants, stents, or electrodes) or any other metal object within or near the head (excluding the mouth), which cannot be safely removed;
- clinically significant unstable medical condition;
- if female: pregnant, not using medically acceptable means of birth control, or currently breastfeeding;
- other condition, which in the judgment of the Investigator could prevent the subject from completion of the study;
- for participants in the MRI study: ferromagnetic metal implant or other contraindication to imaging in a 3 Tesla MRI;
- past treatment with TMS therapy.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: sTMS active
Treatment with the NEST Device
|
The NeoSync EEG Synchronized TMS (NEST) is an electromechanical medical device that produces and delivers a sinusoidal magnetic field to areas of the brain in the treatment of Bipolar Depression.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Mean MADRS Total Score Change (Last Observation Carried Forward)
Tidsram: Baseline to week 6 reported
|
The Montgomery-Asberg Depression Rating Scale (MADRS) will be performed as a baseline and endpoint assessments and efficacy measure.
It's considered the gold standard for rating depression severity and used frequently in clinical trials.
The MADRS score ranges from 0 to 60; a score of 0-6 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicates at least moderate severity.
|
Baseline to week 6 reported
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Mean HDRS-17 Total Score Change (Last Observation Carried Forward)
Tidsram: Baseline and week 6
|
The Hamilton Rating Scale for Depression (HRSD-28) will be done at baseline and endpoint assessments.
The HRSD-17 score, derived from the HRSD-28, will be analyzed.
The HRSD-17 score ranges from 0-52; a score of 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicates at least moderate severity.
|
Baseline and week 6
|
Mean IDS-SR Score Change (Last Observation Carried Forward)
Tidsram: Baseline through week 6
|
The Inventory of Depressive Symptomatology (IDS-SR) will be performed as a baseline and after every 5 treatments.
It's a standardized self-rating scale for depressive symptom severity used in many clinical trials.
IDS-SR total score ranges from 0 to 84; a score of 0-13 is generally accepted to be within the normal range (or reflect clinical remission), while a score of 26 or higher indicates at least moderate severity.
Single value was average mean IDS-SR score change.
|
Baseline through week 6
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Linda Carpenter, MD, Butler Hospital, Mood Disorders Research Program, Brown Department of Psychiatry and Human Behavior
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 maj 2016
Primärt slutförande (Faktisk)
19 november 2018
Avslutad studie (Faktisk)
19 november 2018
Studieregistreringsdatum
Först inskickad
7 juni 2016
Först inskickad som uppfyllde QC-kriterierna
18 juli 2016
Första postat (Uppskatta)
21 juli 2016
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
9 april 2020
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
31 mars 2020
Senast verifierad
1 mars 2020
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 1601-004
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
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