Depressive DisorderPhase 2NCT02410421

e-PAT Neuromod Evaluation of Personalized rTMS for Resistant Depression

A Phase 2 study testing Functional magnetic resonance imaging used to individualize rTMS protocol using robotic coil positioning in people with Depressive Disorder and Treatment-Resistant, run by University Hospital, Strasbourg, France.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

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Trial summary

Although repetitive trans-cranial magnetic stimulation (rTMS) is an effective therapy for resistant depression, it still fail to remit up to 70% of these patients. We hypothesize that personalizing the procedure using functional MRI to better select dysfunctional regions and robotic coil placement to stimulate these… Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Depressive Disorder, Treatment-Resistant
What is being tested?: Functional magnetic resonance imaging used to individualize rTMS protocol using robotic coil positioning
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 0 participants
Where: No sites listed yet
Study dates: Start not givento May 2020
Phase: Phase 2
Are there results?: None posted in the registry

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 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Aged from 18 to 65 Y
Affiliated to the health insurance
Having signed an informed consent
Suffering from major depression according to the DSM5
Unresponsive or incomplete remission after at least one trial of antidepressant (> 6 weeks at efficient dose or side effects)
Treatment stable for > 6 weeks

Who cannot join

Contraindication for MRI, rTMS or tDCS: non-removable ferromagnetic body, prosthesis, pacemaker, medication delivered by an implanted pump clip or vascular stent, heart valve or ventricular shunt, seizure disorders, skin pathology in the region of tDCS electrode placement.
Pregnancy
Severe and non-stabilized somatic pathology
Patients deprived of liberty or hospitalized without their consent

About this study

Official title: Validation of Individualized rTMS Protocol Using Non Invasive Functional Brain Imaging and Robotic Coil Placement in Resistant Depression: Comparison With Classical rTMS and tDCS

In this small proof of principle study our primary outcome measure will be the correction of the MRI anomalies. Symptoms reduction and the proportion of remitters will be secondary outcome measurements.

Conditions: Depressive Disorder, Treatment-Resistant
Being tested: Functional magnetic resonance imaging used to individualize rTMS protocol using robotic coil positioning
Keywords: Individualized Medicine, Functional Neuroimaging, Robotic Proceedure, Transcranial Magnetic Stimulation, Repetitive, Transcranial Direct Current Stimulation Monocentric, Compariative Cross-Over 3 Arms Study Randomized, Single-Blind Method
Medical subject headings: Depressive Disorder

What participants receive

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

Functional magnetic resonance imaging used to individualize rTMS protocol using robotic coil positioningProcedure or surgery

Study groups in NCT02410421
Study group	Role	What they receive
Individualized rTMS protocol	Experimental	The target region will be defined by comparing the rCBF scan of the patient to a control population (n = 80). rCBF will be measured using the QUIPS2 arterial spin labeling sequence on a Siemens 3T Verio. The therapeutic protocol will be design to correct the rCBF anomaly first by defining each point where to deliver the stimulation than the stimulation protocol for each point (180% of active motor threshold, 4-second 10 Hz train duration, with 26-second intertrain interval for a total of 3000 pulses). The whole target will be homogeneously stimulated. The active motor threshold will be assessed. The programmed protocol will be delivered while a figure of eight coil will be positioned by a robotic device (Axilum Robotics). The procedure will be repeated twice a day for 10 days over 2 weeks. Receives: Procedure: Functional magnetic resonance imaging used to individualize rTMS protocol using robotic coil positioning
High frequency rTMS as usual	Active comparator	rTMS will be performed as usual using a figure-eight coil: Defining the active motor threshold. For each session positioning the coil 5 cm ahead of the abductor pollicis brevis muscle, stimulating at 180% of active motor threshold (10 Hz, 4-second train duration, and 26-second intertrain interval) for 37.5 minutes (3000 pulses per session), twice a day for 10 days over 2 weeks. Coil and stimulator will remain the same between individualized and "as usual" proceedures. Receives: Procedure: Functional magnetic resonance imaging used to individualize rTMS protocol using robotic coil positioning
Trans-cranial direct current stimulation (tDCS)	Active comparator	tDCS will be performed as usual: After controlling for skin healthiness, the anode and the cathode will be respectively placed over F3 and F4. A commercial devices (MagStim), will deliver a constant current of 2 mA through 25 cm2 saline-soaked rubber sponges for 20 min per session. The procedure will be repeated twice a day for 10 days over 2 weeks. Receives: Procedure: Functional magnetic resonance imaging used to individualize rTMS protocol using robotic coil positioning

What is being measured

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

Reduction of the target regional cerebral blood flow (rCBF) anomaly
The target region will be defined by comparing the rCBF scan of the patient to a control population (n = 80). rCBF will be measured using the QUIPS2 arterial spin labeling sequence on a Siemens 3T Verio. We will compare the average rCBF of the target region before and after the therapeutic protocol between the different procedures (ANOVA).
Measured: difference between before (D-7 to -1) and after (D+15 to +21) each therapeutic protocol (D = day of the beginning of the protocol)
Reduction of the functional connectivity anomalies
Functional connectivity map of the target region will be performed by extracting its average temporal course and looking at the region(s) which activity is correlated (smoothed by a 8 mm Gaussian kernel). The contrast map of each patient will be compared to the one of a control population submitted to the same analysis. We will compare the number of above threshold voxels (F-test, p < 0.05 uncorrected, extension > 1 cm3) before and after the therapeutic procedure (ANOVA). We will compare the average rCBF of the target region before and after the therapeutic protocol between the different procedures (ANOVA).
Measured: difference between before (D-7 to -1) and after (D+15 to +21) each therapeutic protocol (D = day of the beginning of the protocol)

Secondary outcomes (2)

Symptoms evaluated by the clinician (QIDS16-C)
See http://www.ids-qids.org/ for documentation relative to these scales.
Computation will be performed in terms of :
- Percentage of symptom reduction
- Number responders (reduction of more than 50% of symptoms)
- Numbers of remitters (QIDS16-C ≤ 6).
Measured: difference between before (D-7 to -1) and after (D+15 to +21) each therapeutic protocol (D = day of the beginning of the protocol)
Symptoms evaluated by the patient (QIDS30-SR)
See http://www.ids-qids.org/ for documentation relative to these scales.
Computation will be performed in terms of :
- Percentage of symptom reduction
- Number responders (reduction of more than 50% of symptoms)
- Numbers of remitters (QIDS16-C ≤ 6).
Measured: difference between before (D-7 to -1) and after (D+15 to +21) each therapeutic protocol (D = day of the beginning of the protocol)

Timeline

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

?May 2020

First posted7 Apr 2015 (estimated)
Primary completionMay 2020 (estimated)
Study completionMay 2020 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Depressive DisorderStudies of the same condition, open and under way.
More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind
Who is masked: Care provider
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02410421
Sponsor's protocol ID: 5055
Status last verified: Jan 2016
First submitted: 1 Apr 2015
Last updated: 5 Jan 2016
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Depressive Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Validation of Individualized rTMS Protocol Using Non Invasive Functional Brain Imaging and Robotic Coil Placement in Resistant Depression: Comparison With Classical rTMS and tDCS
ClinicalTrials.gov ID: NCT02410421
Acronym / sponsor ID: 5055
Conditions: Depressive Disorder, Treatment-Resistant
Keywords: Individualized Medicine, Functional Neuroimaging, Robotic Proceedure, Transcranial Magnetic Stimulation, Repetitive, Transcranial Direct Current Stimulation Monocentric, Compariative Cross-Over 3 Arms Study Randomized, Single-Blind Method
Phase: Phase 2
Study type: Interventional
Recruitment status: Withdrawn
Enrolment: 0 participants (actual)
Lead sponsor: University Hospital, Strasbourg, FranceUniversity, hospital or other
Primary completion: May 2020 (estimated)
Study completion: May 2020 (estimated)
First posted: 7 Apr 2015 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (care provider)
Number of arms: 3

Arm	Type	Receives
Individualized rTMS protocol	Experimental	Procedure: Functional magnetic resonance imaging used to individualize rTMS protocol using robotic coil positioningThe target region will be defined by comparing the rCBF scan of the patient to a control population (n = 80). rCBF will be measured using the QUIPS2 arterial spin labeling sequence on a Siemens 3T Verio. The therapeutic protocol will be design to correct the rCBF anomaly first by defining each point where to deliver the stimulation than the stimulation protocol for each point (180% of active motor threshold, 4-second 10 Hz train duration, with 26-second intertrain interval for a total of 3000 pulses). The whole target will be homogeneously stimulated. The active motor threshold will be assessed. The programmed protocol will be delivered while a figure of eight coil will be positioned by a robotic device (Axilum Robotics). The procedure will be repeated twice a day for 10 days over 2 weeks.
High frequency rTMS as usual	Active comparator	Procedure: Functional magnetic resonance imaging used to individualize rTMS protocol using robotic coil positioningrTMS will be performed as usual using a figure-eight coil: Defining the active motor threshold. For each session positioning the coil 5 cm ahead of the abductor pollicis brevis muscle, stimulating at 180% of active motor threshold (10 Hz, 4-second train duration, and 26-second intertrain interval) for 37.5 minutes (3000 pulses per session), twice a day for 10 days over 2 weeks. Coil and stimulator will remain the same between individualized and "as usual" proceedures.
Trans-cranial direct current stimulation (tDCS)	Active comparator	Procedure: Functional magnetic resonance imaging used to individualize rTMS protocol using robotic coil positioningtDCS will be performed as usual: After controlling for skin healthiness, the anode and the cathode will be respectively placed over F3 and F4. A commercial devices (MagStim), will deliver a constant current of 2 mA through 25 cm2 saline-soaked rubber sponges for 20 min per session. The procedure will be repeated twice a day for 10 days over 2 weeks.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Aged from 18 to 65 Y
Affiliated to the health insurance
Having signed an informed consent
Suffering from major depression according to the DSM5
Unresponsive or incomplete remission after at least one trial of antidepressant (> 6 weeks at efficient dose or side effects)

Key exclusion criteria (4 listed)

Contraindication for MRI, rTMS or tDCS: non-removable ferromagnetic body, prosthesis, pacemaker, medication delivered by an implanted pump clip or vascular stent, heart valve or ventricular shunt, seizure disorders, skin pathology in the region of tDCS electrode placement.
Pregnancy
Severe and non-stabilized somatic pathology
Patients deprived of liberty or hospitalized without their consent

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Functional magnetic resonance imaging used to individualize rTMS protocol using robotic coil positioning	Procedure or surgery	High frequency rTMS as usual, Individualized rTMS protocol, Trans-cranial direct current stimulation (tDCS)

Primary outcome

Reduction of the target regional cerebral blood flow (rCBF) anomaly
Time frame: difference between before (D-7 to -1) and after (D+15 to +21) each therapeutic protocol (D = day of the beginning of the protocol)
The target region will be defined by comparing the rCBF scan of the patient to a control population (n = 80). rCBF will be measured using the QUIPS2 arterial spin labeling sequence on a Siemens 3T Verio. We will compare the average rCBF of the target region before and after the therapeutic protocol between the different procedures (ANOVA).
Reduction of the functional connectivity anomalies
Time frame: difference between before (D-7 to -1) and after (D+15 to +21) each therapeutic protocol (D = day of the beginning of the protocol)
Functional connectivity map of the target region will be performed by extracting its average temporal course and looking at the region(s) which activity is correlated (smoothed by a 8 mm Gaussian kernel). The contrast map of each patient will be compared to the one of a control population submitted to the same analysis. We will compare the number of above threshold voxels (F-test, p < 0.05 uncorrected, extension > 1 cm3) before and after the therapeutic procedure (ANOVA). We will compare the average rCBF of the target region before and after the therapeutic protocol between the different procedures (ANOVA).

2 secondary outcomes

Symptoms evaluated by the clinician (QIDS16-C)
Time frame: difference between before (D-7 to -1) and after (D+15 to +21) each therapeutic protocol (D = day of the beginning of the protocol)
Symptoms evaluated by the patient (QIDS30-SR)
Time frame: difference between before (D-7 to -1) and after (D+15 to +21) each therapeutic protocol (D = day of the beginning of the protocol)

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2016.

Related trials for Depressive Disorder

Recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jack FOUCHER, MD principal investigator

Service de Psychiatrie 1, Hôpitaux Universitaires de Strasbourg

Questions about this trial

What is this clinical trial studying?

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 4 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: withdrawn, as of the sponsor's last update on 5 Jan 2016. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Reduction of the target regional cerebral blood flow (rCBF) anomaly (time frame: difference between before (D-7 to -1) and after (D+15 to +21) each therapeutic protocol (D = day of the beginning of the protocol)). The study lists 2 primary outcomes in all. 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 NCT02410421.

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 5 Jan 2016.