Assessing Repetitive Transcranial Magnetic Stimulation as... | NCT00190216

Studies
Assessing Repetitive Transcranial Magnetic Stimulation as a Treatment for Refractory Depression (rTMS)

NCT00190216

Sponsor

Assistance Publique - Hôpitaux de Paris

Status

Terminated

Last Update Posted

Nov 8, 2007Estimated

Enrollment

60Actual

Phase

Phase 3

Conditions

Depression

Interventions

Magnetic stimulator

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
P000606

Status Module

Record Verification Date

Jul 2005

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

terminated

Expanded Access Info

Start Date

Dec 2001

Primary Completion Date

Not provided

Completion Date

Oct 2007Actual

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Sep 13, 2005

First Posted Date

Sep 19, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 6, 2007

Last Update Posted Date

Nov 8, 2007Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Assistance Publique - Hôpitaux de ParisOTHER

Collaborators

Name	Class
Institut National de la Santé Et de la Recherche Médicale, France	OTHER_GOV
International Atomic Energy Agency	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The hypothesis of this study was that transcranial magnetic stimulation (TMS) focused on hyperfunctional cerebral areas should be more effective in treating depressive symptoms than stimulations not taking into account the functional specificity of the patient. The goal was to compare the effects of "guided" TMS, using neuroimaging to guide TMS on dysfunctional cortical regions individually detected by neuroimaging, with "standard TMS", as used in most studies, over the left prefrontal cortex, and with sham TMS, in patients with resistant depression.

Detailed Description

The objectives of the study were :

To localize the site of lowest frontal activity in each patient with resistant depression, using PET to measure regional cerebral metabolic rates for glucose (rCMRGlu).
To demonstrate that high-frequency TMS (10Hz) guided on that site is more effective than standard or sham TMS, in resistant depressed patients, using a doubled blind controlled procedure.
To assess the effects of TMS on regional cerebral metabolism using rCMRGlu PET after 10 sessions of TMS treatments.

Depressed patients meeting DSM-IV criteria for Major Depressive Disorder, aged between 18 and 55, have been included. They met criteria for depression resistant to antidepressant drugs They were randomised in 3 groups: guided prefrontal TMS, standard left prefrontal and sham left prefrontal TMS.

rTMS was administered daily on working days, for two weeks. Ten stimuli per second (10Hz) were applied in 20 courses so that patients received 1600 stimuli per day. Guided TMS was on a prefrontal target corresponding to the highest statistically significant hyperfunctional cluster determined with rCMRGlu PET. Standard stimulation was left pre-frontal, 5 cm anterior to the optimal stimulation point of the abductor pollices brevis. Stimulation strength was chosen at 90% relative to motor threshold. Sham rTMS used a procedure identical to the real standard treatment, but using a sham coil.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Label	Type	Description	Intervention Names
A	Experimental		Device: Magnetic stimulator

Name	Type	Description	Arm Group Labels	Other Names
Magnetic stimulator	Device		A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The primary outcome will be measured at 2 weeks, using depression scales scores : Hamilton depression rating scale, and Montgomery and Asberg Depression Rating Scale		at 2 weeks

Secondary Outcomes

Measure	Description	Time Frame
Depressive psychomotor retardation will be assessed at 2 weeks		at 2 weeks
All depression measures will be assessed at 4 weeks, 2 weeks after the end of the trial to evaluate the lasting effects.		at 4 weeks, 2 weeks after the end of the trial

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Major depression (according to DSM-IV)resistant to at least two medical antidepressant treatment of different pharmacological action, prescribed for at least one month each at an effective dosage, without therapeutical result.
Hospitalisation in the service of an investigator
Informed consent signed

Exclusion Criteria:

Presence of metallic parts inside the body (pace-maker, vascular clip, cardiac valve, prothesis...)
Severe somatic or central nervous system disease
Familial history of comitiality
Pregnancy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Marie-Laure PAILLERE MARTINOT, MD; PhD	Assistance Publique - Hôpitaux de Paris	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Albert Chenevier Hospital, Department of psychiatry		Créteil		94000	France

Condition Browse Module

MeSH Terms

ID	Term
D003863	Depression

Ancestor Terms

ID	Term
D001526	Behavioral Symptoms
D001519	Behavior

Browse Leaves

Not provided

Browse Branches

Not provided