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NCT Number: NCT06813313

Theta Burst Stimulation With an 8-Coil Versus H1-Coil for Resistant Depression

The goal of this clinical trial is to compare response rates after treatment with Figure Eight-Coil TMS versus H-Coil TMS on the prefrontal cortex left dorsolateral, in patients suffering from depression resistant. The main question it aims to answer is:

rTBS (accelerated neuronavigated intermittent Theta Burst Stimulation) is more effective than hTBS (accelerated deep intermittent Theta Burst Stimulation) in the treatment of resistant depression in terms of response rate.?

Researchers will compare Figure Eight-Coil TMS (rTBS) versus H-Coil TMS (hTBS) to see if rTBS is more effective than hTBS.

Participants will:

* Receive, for each stimulation method, 8 sessions per day spaced 50 minutes apart, over 5 days. * Have visit all day of stimulation for checkups and tests. * Have a a research MRI before and after treatment. * Have follow-up visits at 1 month, 2 months, 3 months, 6 months, and 12 months post-treatment, via teleconsultation.

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Key information

Conditions

Treatment of Resistant Depression H1-Coil Theta Burst Stimulation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients over 18 years of age
  • Presenting a major depressive episode according to the DSM-5-TR criteria, occurring as part of major depressive disorder (unipolar depression)
  • The major depressive episode must meet the criteria for treatment resistance, defined by a lack of response to at least two different antidepressant treatments prescribed at an effective dose for a duration of 6 weeks or more
  • Stable treatment for at least 6 weeks
  • Affiliation with a social security system or State Medical Assistance (Aide Médicale d'État)
  • Patient agrees to participate in the study and has signed an informed consent form

Exclusion criteria

  • Presence of a contraindication to TMS: epilepsy, intracranial foreign body, cochlear implant, retinal implant, pacemaker
  • Presence of a bipolar disorder according to DSM-5-TR criteria
  • Presence of catatonic or psychotic features during the current episode
  • Presence of severe psychiatric disorders other than a major depressive episode
  • Presence of neurological disorders
  • Unstable epilepsy
  • Current moderate to severe addiction disorders other than caffeine and/or tobacco
  • Current suicidal ideation
  • Use of any brain stimulation treatment (ECT, rTMS, tDCS) for the current episode
  • Pregnancy or breastfeeding
  • Women of childbearing potential without effective contraception
  • Persons under guardianship or legal protection

Treatment and study plan

repetitive transcranial magnetic stimulation

Device

A burst of 3 pulses sent at a frequency of 50 Hz, repeated with a frequency of 5 Hz for 2 seconds, followed by an 8-second pause. This sequence is repeated for 59 cycles, totaling 9 minutes and 50 seconds, with a total of 1800 pulses.

Primary outcomes

  1. The response rate according to the MADRS scale

    Time frame: Before the treatment and after the treatment at 5 day.

    The response rate is defined as an improvement of more than 50% compared to baseline on the MADRS clinical scale (Montgomery-Asberg Depression Rating Scale). The MADRS consists of 10 items, each scored from 0 to 6 : depressive mood, appetite, sleep, psychomotor retardation, anxiety, suicidal thoughts, cognitive impairment, pessimism, loss of control and demoralization. The total score is the sum of the scores for all 10 items. The overall score can range from 0 to 60.

    0 to 6: No depression 7 to 19: Mild depression 20 to 34: Moderate depression 35 to 60: Severe depression

Secondary outcomes

  1. Clinical improvement of treatment-resistant depression

    Time frame: Before the treatment and after the treatment at 5 days.

    We use:

    • MADRS (Montgomery-Åsberg Depression Rating Scale) : Remission: A MADRS score of less than 10.

  2. Clinical improvement of treatment-resistant depression

    Time frame: Before the treatment and after the treatment at 5 days.

    We use:

    • HDRS-17 (Hamilton Depression Rating Scale - 17 items): The scale contains 17 items, each scored on a scale from 0 to 4, 0 to 2, or 0 to 3, depending on the item. The total score is obtained by adding the scores of all 17 items. The total score can range from 0 to 52.

    Response: A reduction of 50% or more in the total HDRS-17 score compared to baseline is generally considered a response to treatment.

    Remission: A score of 7 or less is typically considered remission from depression.

  3. Clinical improvement of treatment-resistant depression

    Time frame: Before the treatment and after the treatment at 5 days.

    We use:

    • QIDS-SR : The patient answers the 16 items, each assessing various depressive symptoms, and the score ranges from 0 to 27, based on their experiences over the past week. A 50% reduction in the total score from baseline is considered a response.

  4. Clinical improvement of treatment-resistant depression

    Time frame: Before the treatment and after the treatment at 5 days.

    We use:

    • EQ5D : The EQ-5D is a brief tool for assessing health-related quality of life. It measures 5 key dimensions of health.

  5. Tolerance to treatment

    Time frame: Each visits of clinical trial : each day of treatment (5 days), at 1 month, 2 month, 3 month, 6 month and 12 month.

    Rate of adverse effects and rate of premature withdrawal from the study.

  6. Improvement of cognitive functions.

    Time frame: Before the treatment and after the treatment at 5 day.

    Trail Making Test A and B (version from the Group for the Evaluation of Executive Functions, GREFEX, Army individual test 1944, based on Godefroy, 2012)

  7. Improvement of cognitive functions.

    Time frame: Before the treatment and after the treatment at 5 day.

    Free Recall / Cued Recall at 16 items (RL/RI-16), version A or B

  8. Improvement of cognitive functions.

    Time frame: Before the treatment and after the treatment at 5 day.

    Stroop Test (Golden, 1978)

  9. Improvement of cognitive functions.

    Time frame: Before the treatment and after the treatment at 5 day.

    Wisconsin Card Sorting Test (WCST), GREFEX version

  10. Improvement of cognitive functions.

    Time frame: Before the treatment and after the treatment at 5 day.

    N-back Task (version from the Attention Assessment Tests, TAP)

  11. Improvement of cognitive functions.

    Time frame: Before the treatment and after the treatment at 5 day.

    Go/No-Go Inhibition Task (TAP version)

  12. Improvement of cognitive functions.

    Time frame: Before the treatment and after the treatment at 5 day.

    Digit Span and "Coding" subtest from the Wechsler Adult Intelligence Scale (WAIS-IV)

  13. Improvement of cognitive functions.

    Time frame: Before the treatment and after the treatment at 5 day.

    Verbal Fluency Test (GREFEX version)

  14. Improvement of neurophysiological functions

    Time frame: Before the treatment and after the treatment at 5 day.

    Variation in brain functional connectivity between baseline and the end of the rTMS treatment.

  15. Improvement of neurophysiological functions

    Time frame: Before the treatment and after the treatment at 5 day.

    Neurobiological/neurophysiological variables: change in heart rate variability.

  16. Improvement of neurophysiological functions

    Time frame: Before the treatment and after the treatment at 5 day.

    Change in serum BDNF levels.

  17. Improvement of neurophysiological functions

    Time frame: Before the treatment and after the treatment at 5 day.

    Change in motor cortex neuroexcitability.

  18. Pain detection and pain tolerance using an experimental pain task

    Time frame: Before the treatment and after the treatment at 5 day.

    Cold pain using the cold pressor task and mechanical pain using the algomete

Study contacts

Contact information is provided by the study sponsor or research team.

Dominique Professor Januel, Professor of Medicine

CONTACT

[email protected]

0143093232 ext. +33143093232

Youcef Bencherif, Project Manager

CONTACT

[email protected]

0143093232 ext. +33143093232

Sponsors and collaborators

Lead sponsor

Dominique JANUEL

Other

Registry information

Official study title

Randomized Controlled Trial of Two Accelerated Transcranial Magnetic Stimulation Methods in the Treatment of Resistant Depression: Intermittent Theta Burst Stimulation With an 8-Coil Versus H1-Coil

Acronym: rTBShTBS

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Feb 6, 2025
Registry last updated
Feb 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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