NCT07876908Toboroz
SAINT® Therapy for Memory Problems in Older Adults With Treatment-Resistant Depression
An Open-Label Feasibility Trial to Assess the Efficacy of the Magnus Neuromodulation System With Stanford Accelerated Intelligent Neuromodulation Therapy (SAINT)® Technology to Treat Memory Deficits in Older Patients With Treatment-Resistant Depression
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. okt. 28.
Rövid összefoglaló (regiszter, angolul)
The goal of this clinical trial is to learn whether Stanford Accelerated Intelligent Neuromodulation Therapy (SAINT®), a type of transcranial magnetic stimulation (TMS), is safe and may improve memory and thinking in adults aged 65 or older with treatment-resistant depression and memory concerns. Researchers will also study whether SAINT® improves depression symptoms. The main questions it aims to answer are: * Does SAINT® improve memory and thinking five days after treatment? * Does SAINT® improve depression symptoms and overall well-being? * Do changes in memory, mood, or daily activities last for up to one year? * What side effects or safety concerns occur during and after treatment? All participants will receive SAINT® treatment. There is no placebo group. Participants will: * Complete memory, mood, and health assessments and have an MRI scan * Receive 10 TMS sessions each day for 5 days in a row * Return for follow-up visits for up to 12 months Researchers will track changes in memory, mood, daily activities, and side effects.
- Állapot (regiszter)
- Toboroz
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 20 (tervezett)
- Első benyújtás
- 2026. okt. 9.
- Kezdés
- 2026. okt. 1.
- Elsődleges befejezés
- 2029. jan. 1.
- Fő szponzor
- BrainHealth Solutions, Inc.
- Betegségek
- Depresszió
- NCT-szám
- NCT07876908
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Tervezett résztvevők: 20
- 2026. okt. 1. és az elsődleges befejezés (2029. jan. 1.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Korábbi kezelés
- Non-removable metal or an implanted medical device in or near the head that is not safe for transcranial magnetic stimulation or magnetic resonance imaging, such as a cochlear implant, aneurysm clip, stent, or metal fragment
- A brain condition that may increase seizure risk, such as prior brain surgery, skull defect, stroke-related brain disease, or brain tumor
- Use of a medication or procedure that the study doctor determines may significantly interfere with transcranial magnetic stimulation treatment
Más betegség
- History of epilepsy or a seizure disorder, except for isolated febrile seizures during childhood
- A current psychiatric diagnosis other than major depressive disorder that could affect safe participation, including schizophrenia, schizoaffective disorder, bipolar disorder, or post-traumatic stress disorder
- A diagnosis of borderline, paranoid, histrionic, schizotypal, schizoid, or antisocial personality disorder
- A serious or unstable medical condition that could make participation unsafe or affect interpretation of the study results
- Resting heart rate below 40 beats per minute or above 110 beats per minute at the clinic visit
- Any other condition that, in the study doctor's judgment, would make participation unsafe or prevent completion of the study requirements
Egyéb
- Pregnancy
- Unable or unwilling to use an acceptable method of birth control during the 5-day treatment period and for 30 days afterward, if of childbearing potential or sexually active with a partner of childbearing potential
- An implanted neurostimulator in or near the head, such as a deep brain stimulator or vagus nerve stimulator
- Any other contraindication to transcranial magnetic stimulation listed in the device instructions for use that the study doctor believes would increase risk
- A clinically significant abnormal magnetic resonance imaging (MRI) result
- Substance abuse or dependence within the past year, including alcohol or benzodiazepines, except caffeine or nicotine
- High current risk of suicide or a suicide attempt within the past 6 months
Kiket keres a vizsgálat
- Age 65 years or older
- Diagnosis of treatment-resistant depression
- Current depressive symptoms, with a Montgomery-Asberg Depression Rating Scale (MADRS) score of 20 or higher
- A memory concern reported by the participant or caregiver
- A Mini-Mental State Examination (MMSE) score between 10 and 28
- Able to understand the study, provide written informed consent, and complete study assessments
- Determined by an independent treating clinician to be an appropriate candidate for accelerated SAINT treatment, consisting of 10 treatment sessions per day for 5 consecutive days
- Completed an amyloid PET scan and/or Lumipulse G pTau217/Amyloid 1-42 blood test as part of usual medical care within 6 months before the baseline visit
- Health insurance coverage confirmed for rTMS/SAINT treatment for treatment-resistant depression
- Willing to follow study requirements, including medication restrictions and study visits
Életkor a regiszterben: 65 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| BrainHealth Solutions Inc. Ennek a helyszínnek vagy a koordinátora? Erősítsd meg az állapotát | Costa Mesa | Egyesült Államok | Toboroz |
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