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Randomized Controlled Trial Testing the Efficacy of Transcranial Magnetic Stimulation by Accelerated & High-dose Theta-burst, Functional Imaging Guided, in the Treatment of Depression in Elderly Subjects With Cognitive Impairment

NCT07188753 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 186

Last updated 2025-09-23

No results posted yet for this study

Summary

This trial aims at testing a new intensive, personalized functional targeting, transcranial magnetic stimulation technique for elderly patients (aged ≥ 65 years) suffering from a current treatment resistant depressive episode to at least one antidepressant, and suffering from significant secondary cognitive impairment.

The intervention will be based on an accelerated neuromodulation technique using intermittent theta bursts (aiTBS) guided by a personalised funcitonal target within the left dorsolateral prefrontal cortex (DLPFC), using the SAINT® technology, which was recently cleared by the FDA.

Conditions

Interventions

OTHER

transcranial magnetic stimulation by accelerated & high-dose theta-burst, functional imaging guided, i

Participants will then be treated with 1,800 pulses of iTBS (3-pulse 50-Hz bursts at 5-Hz for 2-second trains, with trains every 10 seconds) per session at 90% resting motor threshold and depth-adjustment to the personalized functional target. Each session will last 10 min followed by a 50-minute intersession interval. Ten sessions will be applied per day (18,000 pulses/day) for 5 consecutive days (90,000 total pulses).

Sponsors & Collaborators

  • Rennes University Hospital

    lead OTHER

Principal Investigators

  • Jean-Marie BATAIL, M.D.,Ph.D. · C. H. GUILLAUME REGNIER RENNES

  • Bruno MILLET, PH-PD · APHP- LA PITIE

  • Ghina HARIKA GERMANEAU, MD · Centre Hospitalier Henri Laborit

  • Maud ROTHARMEL, MD · CHS DU ROUVRAY SOTTEVILLE-LES-ROUEN

  • Samuel BULTEAU, MD · Nantes University Hospital

  • Noomane BOUAZIZ, MD · EPS VILLE EVRARD

  • Moussa CHALAH, MD · GHU PARIS

  • David SZEKELY, MD · Centre Hospitalier Princesse Grace

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-15
Primary Completion
2031-06-15
Completion
2031-12-15

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07188753 on ClinicalTrials.gov