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Treatment of Resistant DepressionrTBShTBSNCT06813313

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

A study testing repetitive transcranial magnetic stimulation in people with Treatment of Resistant Depression and H1-Coil, run by Dominique JANUEL.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
repetitive transcranial magnetic stimulation
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
108 participants
Where
No sites listed yet
Study dates
16 Feb 2025to 18 Nov 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Dominique Professor Januel, Professor of Medicine contact

0143093232 ext. +33143093232

d.januel@epsve.fr

Youcef Bencherif, Project Manager contact

0143093232 ext. +33143093232

y.bencherif@epsve.fr

About this study

Official 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

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.?

Read more

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.
Being tested
repetitive transcranial magnetic stimulation
Keywords
Resistant Depression, H1-Coil, Theta burst stimulation, TMS, Accelerated Transcranial Magnetic Stimulation, Intermittent Theta Burst Stimulation with an 8-Coil versus H1-Coil

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • repetitive transcranial magnetic stimulationDevice

    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.

Study groups in NCT06813313
Study groupRoleWhat they receive
rTMS ARMOtherThe treatment consists of 8 sessions per day for 5 days, with daily self-assessments for 1 week. Each session lasts approximately 9 minutes and 50 seconds with a 50-minute break between sessions. The application of rTBS will be done using the Cool-B65 coil, targeting the DLPFC region identified by neuronavigation.
Receives: Device: repetitive transcranial magnetic stimulation
hTBS ArmOtherThe treatment consists of 8 sessions per day for 5 days, with daily self-assessments for 1 week. Each session lasts approximately 9 minutes and 50 seconds with a 50-minute break between sessions. The application of hTBS will be done using the H1 coil, targeting the DLPFC region located 6 cm forward from the motor cortex.
Receives: Device: repetitive transcranial magnetic stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The response rate according to the MADRS scale

    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

    Measured: Before the treatment and after the treatment at 5 day.

Secondary outcomes (18)

  1. Clinical improvement of treatment-resistant depression

    We use:

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

    Measured: Before the treatment and after the treatment at 5 days.

  2. Clinical improvement of treatment-resistant depression

    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.

    Measured: Before the treatment and after the treatment at 5 days.

  3. Clinical improvement of treatment-resistant depression

    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.

    Measured: Before the treatment and after the treatment at 5 days.

  4. Clinical improvement of treatment-resistant depression

    We use:

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

    Measured: Before the treatment and after the treatment at 5 days.

  5. Tolerance to treatment

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

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

  6. Improvement of cognitive functions.

    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)

    Measured: Before the treatment and after the treatment at 5 day.

  7. Improvement of cognitive functions.

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

    Measured: Before the treatment and after the treatment at 5 day.

  8. Improvement of cognitive functions.

    Stroop Test (Golden, 1978)

    Measured: Before the treatment and after the treatment at 5 day.

  9. Improvement of cognitive functions.

    Wisconsin Card Sorting Test (WCST), GREFEX version

    Measured: Before the treatment and after the treatment at 5 day.

  10. Improvement of cognitive functions.

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

    Measured: Before the treatment and after the treatment at 5 day.

  11. Improvement of cognitive functions.

    Go/No-Go Inhibition Task (TAP version)

    Measured: Before the treatment and after the treatment at 5 day.

  12. Improvement of cognitive functions.

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

    Measured: Before the treatment and after the treatment at 5 day.

  13. Improvement of cognitive functions.

    Verbal Fluency Test (GREFEX version)

    Measured: Before the treatment and after the treatment at 5 day.

  14. Improvement of neurophysiological functions

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

    Measured: Before the treatment and after the treatment at 5 day.

  15. Improvement of neurophysiological functions

    Neurobiological/neurophysiological variables: change in heart rate variability.

    Measured: Before the treatment and after the treatment at 5 day.

  16. Improvement of neurophysiological functions

    Change in serum BDNF levels.

    Measured: Before the treatment and after the treatment at 5 day.

  17. Improvement of neurophysiological functions

    Change in motor cortex neuroexcitability.

    Measured: Before the treatment and after the treatment at 5 day.

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

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

    Measured: Before the treatment and after the treatment at 5 day.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Feb 2025
  2. Study start16 Feb 2025 (estimated)
  3. Primary completion18 Nov 2027 (estimated)
  4. Study completion18 Nov 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
108 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06813313
Sponsor's protocol ID
2024-A00954-43
Acronym
rTBShTBS
Status last verified
Feb 2025
First submitted
27 Jan 2025
Last updated
6 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing repetitive transcranial magnetic stimulation in people with Treatment of Resistant Depression and H1-Coil, run by Dominique JANUEL.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 6 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Dominique Professor Januel, Professor of Medicine (0143093232 ext. +33143093232, d.januel@epsve.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The response rate according to the MADRS scale (time frame: Before the treatment and after the treatment at 5 day.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06813313.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2025.

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