What side effects are associated with this type of intervention?

Repetitive transcranial magnetic stimulation (rTMS) is generally well-tolerated, but some patients may experience mild side effects such as scalp discomfort or headaches during treatment. There is also a small risk of seizures, particularly in individuals with a history of epilepsy. Emotional and adherence support via text messages (Text4Support) is a non-invasive intervention and typically does not have physical side effects, though its effectiveness can vary based on individual engagement and response.

What prior FDA approvals exist?

Repetitive transcranial magnetic stimulation (rTMS) has been FDA-approved for the treatment of major depressive disorder, particularly in patients who have not responded to traditional antidepressant medications. rTMS involves the use of magnetic fields to stimulate nerve cells in the brain, which can improve symptoms of depression. While Text4Support, which provides emotional and adherence support via text messages, is not specifically mentioned in FDA approvals, supportive interventions like cognitive-behavioral therapy (CBT) and other forms of psychotherapy are commonly used in conjunction with pharmacological treatments for depression. Combining rTMS with supportive interventions aims to enhance treatment adherence and emotional well-being.

What other types of research exist?

Promising alternatives to rTMS combined with Text4Support for depression patients include: 1) Transcranial Direct Current Stimulation (tDCS), which involves a low electrical current to modulate brain activity and has shown potential in improving depressive symptoms. 2) Vagus Nerve Stimulation (VNS), a non-invasive technique that stimulates the vagus nerve and has been associated with reduced depressive symptoms. 3) Cognitive Behavioral Therapy (CBT) combined with digital health interventions, such as mobile apps or online platforms, to provide emotional support and enhance adherence to treatment.

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Procedure

rTMS + Text4Support for Depression

N/A

Recruiting

Led By Vincent Agyapong, MD, Ph.D

Research Sponsored by University of Alberta

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests whether combining rTMS with daily supportive text messages (Text4Support) is more effective than rTMS alone for people with Treatment-Resistant Depression. rTMS helps activate brain areas related to mood, while Text4Support offers daily encouragement and mental health tips. Repetitive transcranial magnetic stimulation (rTMS) has been studied extensively for its antidepressant effects, showing variable efficacy in reducing depressive symptoms.

Who is the study for?

This trial is for adults over 18 with Major Depressive Disorder (MDD) who haven't improved after trying at least two antidepressant treatments. They must understand English, be able to use a smartphone for texts, and give written consent. It's not for those under 18, pregnant or breastfeeding women, people with learning disabilities, psychotic disorders, personality disorders that affect study participation, involvement in other trials recently, or certain neurological conditions.

What is being tested?

The trial tests if adding Text4Support (a text messaging support system) to repetitive Transcranial Magnetic Stimulation (rTMS), a non-invasive brain stimulation treatment for depression, helps more than rTMS alone. Participants are randomly placed into one of these two groups and followed up at intervals after the six-week active treatment phase.

What are the potential side effects?

Common side effects of rTMS include discomfort at the treatment site during sessions, headache afterwards and rarely seizures. The addition of Text4Support isn't expected to introduce physical side effects but may impact participants' emotional state due to content.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

The Patient Health Questionnaire (PHQ-9)

Secondary study objectives

Columbia Suicide Severity Rating Scale

Generalized Anxiety Disorders Scale (GAD-7)

The World Health Organization - Five Well-Being Index (WHO-5)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Enrolment in rTMS sessions plus Text4SupportExperimental Treatment1 Intervention

Participants in the rTMS plus Text4Support group of the study would be assisted by a study team member assigned that purpose to register onto the Text4Support program. The process would require all participants to input their phone numbers into the Text4Support platform that will be used to deliver the daily messages. Starting a day after enrollment, participants will receive daily supportive text messages designed by mental health therapists, clinical psychologists, psychiatrists, and mental health service users. These messages are based on cognitive behavior therapy principles crafted to enhance positively the mood of its users with depressive symptoms and other related mental health problems of concern. The messages will be pre-programmed into a software program that will deliver the messages to participants automatically to the participants' mobile phones at 10 AM (Mountain Time) and 12 PM (Atlantic Time), and each participant will receive these messages continuously for 6 weeks.

Group II: Enrolment in rTMS sessions aloneActive Control1 Intervention

All study participants will be scheduled to receive 30 sessions of rTMS treatment for 6 weeks as pre-established by the Alberta Health Services Strategic Clinical Network for Addiction and Mental Health and Nova Scotia Health.

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Repetitive transcranial magnetic stimulation (rTMS) treats depression by using magnetic fields to stimulate nerve cells in brain regions involved in mood regulation, such as the dorsolateral prefrontal cortex, helping to normalize brain activity and alleviate depressive symptoms. Text4Support complements this by providing emotional and adherence support through regular text messages, enhancing treatment adherence and offering ongoing emotional support. These combined mechanisms address both the biological and psychological aspects of depression, potentially leading to more comprehensive and sustained improvements in mood and overall well-being for patients.

New targets for rTMS in depression: a review of convergent evidence.