Pilot Study Comparing 10hz vs Theta Burst Stimulation

NCT ID: NCT02800226

Last Updated: 2018-08-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2015-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This pilot study aims at exploring the efficacy of iTBS compared to 10Hz protocol and explore potential biomarkers of treatment response

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Major Depressive Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

10Hz

High Frequency Left repetitive transcranial magnetic stimulation five days per week for 4-6 weeks

Group Type EXPERIMENTAL

10Hz

Intervention Type DEVICE

Magventure Cool B70 Coil with X100 Stimulator and ANT Neuronavigation System

iTBS

intermittent Theta Burst Stimulation (iTBS) five days per week for 4-6 weeks

Group Type ACTIVE_COMPARATOR

iTBS

Intervention Type DEVICE

Magventure Cool B70 Coil with X100 Stimulator and ANT Neuronavigation System

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

10Hz

Magventure Cool B70 Coil with X100 Stimulator and ANT Neuronavigation System

Intervention Type DEVICE

iTBS

Magventure Cool B70 Coil with X100 Stimulator and ANT Neuronavigation System

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* outpatients
* voluntary and competent to consent
* Mini-International Neuropsychiatric Interview (MINI) confirmed diagnosis of Major Depressive Disorder (MDD), single, recurrent between ages 18-65
* failed to achieve a clinical response to an adequate dose of an antidepressant based on an Antidepressant Treatment History Form (ATHF) score of ≥ 3 in the current episode or have been unable to tolerate at least 2 separate trials of antidepressants of inadequate dose and duration (ATHF 1 or 2)
* have a score of ≥ 18 on the Hamilton Depression Rating Score 17-item (HDRS-17)
* have had no increase or initiation of any psychotropic medication in the 4 weeks prior to screening able to adhere to the treatment schedule
* Pass the TMS adult safety screening (TASS) questionnaire
* have normal thyroid functioning based on pre-study blood work

Exclusion Criteria

* have a history of substance dependence or abuse within the last 3 months
* have a concomitant major unstable medical illness, cardiac pacemaker or implanted medication pump
* have active suicidal intent
* are pregnant
* have a lifetime MINI diagnosis of bipolar I or II disorder, schizophrenia, schizoaffective disorder, schizophreniform, delusional disorder, or current psychotic symptoms
* have a MINI diagnosis of obsessive-compulsive disorder, post-traumatic stress disorder (current or within the last year), anxiety disorder (generalized anxiety disorder, social anxiety disorder, panic disorder), or dysthymia assessed by a study investigator to be primary and causing greater impairment than MDD
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of British Columbia

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Fidel Vila-Rodriguez

Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Fidel Vila-Rodriguez, MD

Role: PRINCIPAL_INVESTIGATOR

University of British Columia

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Non-Invasive Neurostimulation Therapies lab, University of British Columbia

Vancouver, British Columbia, Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Canada

References

Explore related publications, articles, or registry entries linked to this study.

Ge R, Downar J, Blumberger DM, Daskalakis ZJ, Vila-Rodriguez F. Functional connectivity of the anterior cingulate cortex predicts treatment outcome for rTMS in treatment-resistant depression at 3-month follow-up. Brain Stimul. 2020 Jan-Feb;13(1):206-214. doi: 10.1016/j.brs.2019.10.012. Epub 2019 Oct 18.

Reference Type DERIVED
PMID: 31668646 (View on PubMed)

Shalbaf R, Brenner C, Pang C, Blumberger DM, Downar J, Daskalakis ZJ, Tham J, Lam RW, Farzan F, Vila-Rodriguez F. Non-linear Entropy Analysis in EEG to Predict Treatment Response to Repetitive Transcranial Magnetic Stimulation in Depression. Front Pharmacol. 2018 Oct 30;9:1188. doi: 10.3389/fphar.2018.01188. eCollection 2018.

Reference Type DERIVED
PMID: 30425640 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

http://NINET.CA

Laboratory Website

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

H13-02340

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Theta-Burst Stimulation to Treat Depression
NCT07033780 RECRUITING PHASE1
Compressed Intermittent Theta Burst Stimulation
NCT04684706 ACTIVE_NOT_RECRUITING NA