The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01431001




Registration number
NCT01431001
Ethics application status
Date submitted
6/09/2011
Date registered
9/09/2011
Date last updated
19/05/2014

Titles & IDs
Public title
Pilot Study in Multi-Coil Repetitive Transcranial Magnetic Stimulation (rTMS) for Treatment Resistant Depression
Scientific title
Determining Effectiveness of Multi-Coil rTMS for Patients With Major Depressive Disorder: A Pilot Study
Secondary ID [1] 0 0
NS-CPS-TRMD-1
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Major Depressive Disorder 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Cervel Neurotech Deep Shaped-Field repetitive transcranial magnetic stimulator (DSF-rTMS)

Experimental: Coil Configuration A - Cervel Neurotech Deep Shaped-Field repetitive transcranial magnetic stimulator (DSF-rTMS)

Experimental: Coil Configuration B - Cervel Neurotech Deep Shaped-Field repetitive transcranial magnetic stimulator (DSF-rTMS)


Treatment: Devices: Cervel Neurotech Deep Shaped-Field repetitive transcranial magnetic stimulator (DSF-rTMS)
The Cervel Neurotech Deep Shaped-Field repetitive transcranial magnetic stimulator is an investigational rTMS device

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Remission from depression - Changes in Hamilton Rating Scale from Depression (HRSD) measured after each block of 5 treatment sessions, 2 weeks post and 4 weeks post
Timepoint [1] 0 0
baseline through 4 weeks post
Secondary outcome [1] 0 0
Safety and tolerability of rTMS - Determined by presence and absence of adverse events recorded daily
Timepoint [1] 0 0
baseline through 4 weeks post

Eligibility
Key inclusion criteria
- Major depressive disorder (MDD)

- Mild to moderate level of resistance or intolerance to antidepressant treatment in the
current episode.

- Will not become pregnant during study.
Minimum age
18 Years
Maximum age
70 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Seizure disorder.

- History of brain injury or active CNS disease.

- Metal implants on or in brain, spinal cord, ear, eye or heart.

- Current use of proconvulsant medications (e.g., bupropion).

- Other significant psychiatric disorder.

- Substance use disorder (not including caffeine or nicotine).

- 7 or more failed treatment attempts for depression in one's lifetime.

- Have failed to clinically remit to an adequate trial of ECT or TMS.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Monash Alfred Psychiatry Research Centre - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Georgia
Country [2] 0 0
United States of America
State/province [2] 0 0
Illinois
Country [3] 0 0
United States of America
State/province [3] 0 0
South Carolina

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Cervel Neurotech, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to assess the efficacy of a Deep Shaped-Field repetitive
transcranial magnetic stimulation (DSF-rTMS) system in the treatment of depression.
Trial website
https://clinicaltrials.gov/show/NCT01431001
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
AnnaMarie Daniels
Address 0 0
Cervel Neurotech
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications