rTMS + Cognitive Therapy for Depression
Recruiting in Palo Alto (17 mi)
Overseen byCarlos A Zarate, M.D.
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: National Institute of Mental Health (NIMH)
Must be taking: Antidepressants
Must not be taking: Seizure threshold-lowering drugs
Disqualifiers: Substance abuse, Tinnitus, Seizure history, others
No Placebo Group
Trial Summary
What is the purpose of this trial?Background:
Repetitive transcranial magnetic stimulation (rTMS) is a treatment for depression. It stimulates the brain. Researchers want to see if using magnetic resonance imaging (MRI) scans helps locate the best area for rTMS in each person. They also want to find other ways to make it more effective.
Objective:
To study the effects of combining MRI- guided transcranial magnetic stimulation (TMS) and talk therapy on the brain in people with depression.
Eligibility:
Adults ages 18-75 with a major depressive disorder and current depression. If taking an antidepressant, should have been doing so for at least 4 weeks.
Design:
Participants will be screened with medical and psychiatric history, psychiatric evaluation, physical exam, and blood and urine tests.
Phase 1 is 1-4 visits in 1 week. Participants will have:
* Brain MRI. Participants will lie on a table in a scanner.
* Questions about their medical history and psychology symptoms
* Tests of mood and thinking
* Tests of brain activity. Participants may do tasks during these tests:
* A cone with magnetic detectors is put on the head.
* A cap with electrodes is put on the scalp.
* TMS. A brief electrical current passes through a wire coil on the scalp.
* A metal disk will be placed on the arm. A nerve will be stimulated with a small electrical shock.
Phase 2 is about 6 to 7 weeks.
* There will be 30 daily sessions of combined therapy and repetitive TMS (rTMS) for 6 weeks.
* Participants will receive rTMS and another therapy by computer.
* For rTMS, repeated pulses will pass through the coil.
* This is followed by up to 3 additional visits, when:
* Participants will repeat Phase 1 tests
* Participants will rate their depression symptoms.
Phase 3 is 3 visits over 3 months. Participants will rate their depression symptoms and repeat some of the previous questionnaires and tests of mood and thinking.
Do I need to stop my current medications to join the trial?
If you are currently taking an antidepressant, you must have been on a stable dose for at least four weeks before joining the study and continue at the same dosage throughout the trial.
What data supports the effectiveness of the treatment rTMS + Cognitive Therapy for Depression?
Research shows that repetitive transcranial magnetic stimulation (rTMS) can improve symptoms in people with major depressive disorder (MDD), and it has been found to enhance cognitive flexibility in patients with depression. This suggests that rTMS, when combined with cognitive therapy, may be effective in treating depression.
12345Is rTMS generally safe for humans?
Repetitive transcranial magnetic stimulation (rTMS) is generally considered safe for humans, with safety guidelines established and updated over the years. While there have been some adverse events like seizures, these are rare, and safety protocols are in place to minimize risks.
678910How is the rTMS + Cognitive Therapy treatment for depression different from other treatments?
The rTMS + Cognitive Therapy treatment is unique because it combines repetitive transcranial magnetic stimulation (rTMS), which uses magnetic fields to stimulate nerve cells in the brain, with cognitive therapy, a type of talk therapy. This combination aims to improve both mood and cognitive flexibility, offering a novel approach compared to traditional treatments like medication or electroconvulsive therapy.
123511Eligibility Criteria
Adults aged 18-75 with major depressive disorder, who have not responded to at least one antidepressant or ECT (unless within the last year), and are on a stable medication dose for four weeks. Participants must understand the study, consent to it, commit to an intensive treatment schedule, use birth control if applicable, and have a depression severity score above set thresholds.Inclusion Criteria
Native English language speaker
All subjects must have undergone a screening assessment under protocol 01-M-0254, The Evaluation of Patients with Mood and Anxiety Disorders and Healthy Volunteers
I have depression that didn't improve after trying at least one antidepressant or ECT, except if ECT was in the last year.
+9 more
Exclusion Criteria
Subjects meeting criteria for Axis II cluster A or B diagnosis based upon DSM-IV TR criteria, which in the judgment of the Investigator may hinder the subjects in completing the procedures required by the study protocol
I have anxiety or PTSD, but my main issue is depression.
You have a higher chance of having seizures due to certain medical conditions or medications that make it more likely.
+27 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
1 week
1-4 visits (in-person)
Treatment
Participants receive 30 daily sessions of combined therapy and repetitive TMS (rTMS) for 6 weeks, with additional visits for repeat tests and symptom rating
6-7 weeks
30 visits (in-person) for treatment, up to 3 additional visits for testing
Follow-up
Participants are monitored for safety and effectiveness after treatment, with standard care for depression and relapse prevention strategy
3 months
3 visits (in-person)
Participant Groups
The trial is testing whether combining MRI-guided transcranial magnetic stimulation (TMS) with cognitive therapy improves depression symptoms more effectively than sham TMS plus cognitive therapy. It includes initial evaluations followed by six weeks of daily sessions and subsequent follow-ups over three months.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Active TMS+ Cognitive TherapyExperimental Treatment1 Intervention
active
Group II: Sham TMS + Cognitive TherapyPlacebo Group1 Intervention
inactive
Active TMS + Cognitive therapy is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as rTMS for:
- Major Depressive Disorder (MDD)
- Treatment-resistant depression
- Obsessive-compulsive disorder (OCD)
- Posttraumatic stress disorder (PTSD)
🇪🇺 Approved in European Union as rTMS for:
- Major Depressive Disorder (MDD)
- Treatment-resistant depression
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
National Institutes of Health Clinical CenterBethesda, MD
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Who Is Running the Clinical Trial?
National Institute of Mental Health (NIMH)Lead Sponsor
References
Improved executive functioning following repetitive transcranial magnetic stimulation. [2019]The cognitive effects of active and sham repetitive transcranial magnetic stimulation (rTMS) were examined in 19 middle-aged and elderly patients with refractory depression. Patients received either active (n = 9) or sham (n = 10) rTMS targeted at the anterior portion of the left middle frontal gyrus. Patients in the active rTMS group improved significantly on a test of cognitive flexibility and conceptual tracking (Trail Making Test-B).
Consensus Recommendations for the Clinical Application of Repetitive Transcranial Magnetic Stimulation (rTMS) in the Treatment of Depression. [2022]To provide expert recommendations for the safe and effective application of repetitive transcranial magnetic stimulation (rTMS) in the treatment of major depressive disorder (MDD).
Long-term maintenance therapy for major depressive disorder with rTMS. [2022]There is growing evidence to support the short-term antidepressant effects of repetitive transcranial magnetic stimulation (rTMS), but few published data pertain to the maintenance treatment of patients with DSM-IV-diagnosed major depressive disorder who have responded acutely to rTMS. We describe long-term maintenance therapy for major depressive disorder with rTMS.
A happiness magnet? Reviewing the evidence for repetitive transcranial magnetic stimulation in major depressive disorder. [2021]First, to conduct a historical review of the evidence for repetitive transcranial magnetic stimulation (rTMS) for major depressive disorder and determine a clinical algorithm. Second, to identify opportunities for research.
Efficacy, Safety and Tolerability of Augmentative rTMS in Treatment of Major Depressive Disorder (MDD): A Prospective Cohort Study in Croatia. [2019]An increasing body of research suggest that repetitive Transcranial Magnetic Stimulation (rTMS) is effective and safe treatment option for patients with major depressive disorder (MDD). The Psychiatric Hospital "Sveti Ivan" has the first TMS laboratory with rTMS and deep TMS (dTMS) in Croatia. The objective of this study was to assess the efficacy, safety and tolerability of augmentative rTMS treatment vs standard treatment in Croatian patients with major depressive disorder (MDD).
Effects of a 2- to 4-week course of repetitive transcranial magnetic stimulation (rTMS) on neuropsychologic functioning, electroencephalogram, and auditory threshold in depressed patients. [2019]The safety of repetitive transcranial magnetic stimulation (rTMS) has only previously been formally studied in volunteers receiving a single session of stimulation or in a small number of depressed subjects receiving a 2-week treatment course. This study examined safety issues in depressed subjects receiving up to 4 weeks of rTMS. Efficacy results from this study have been previously reported.
Adverse events of repetitive transcranial magnetic stimulation in older adults with depression, a systematic review of the literature. [2021]In the last decade, repetitive transcranial magnetic stimulation (rTMS) has been introduced as a non-invasive neuromodulation therapy for depression. Little is known, however, about (serious) adverse events (AE) of rTMS in older adults with a depression. In this article, we want to study what is known about (serious) AE of rTMS in older adults (>60 years) with late-life depression (LLD).
Transcranial magnetic stimulation (TMS) safety: a practical guide for psychiatrists. [2019]Repetitive transcranial magnetic stimulation (rTMS) is increasingly being utilised as a treatment option for depression, and with this comes a need for a practical review of safety issues intended for clinicians. This article provides an overview of the current literature regarding safety issues with rTMS for depression, and provides recommendations for clinical practice.
Safety Review for Clinical Application of Repetitive Transcranial Magnetic Stimulation. [2023]Studies using repetitive transcranial magnetic stimulation (rTMS) in healthy individuals and those with neuropsychiatric diseases have rapidly increased since the 1990s, due to the potential of rTMS to modulate the cortical excitability in the brain depending on the stimulation parameters; therefore, the safety considerations for rTMS use are expected to become more important. Wassermann published the first safety guidelines for rTMS from the consensus conference held in 1996, and Rossi and colleague then published the second safety guidelines from the multidisciplinary consensus meeting held in Siena, Italy in 2008, on behalf of the International Federation of Clinical Neurophysiology. More than 10 years after the second guidelines, the updated third safety guidelines were recently published in 2021. The general safety guidelines for conventional rTMS have not substantially changed. Because the most frequently used rTMS protocol is conventional (low- and high-frequency) rTMS in research and clinical settings, we focus on reviewing safety issues when applying conventional rTMS with a focal cortical stimulation coil. The following issues will be covered: 1) possible adverse events induced by rTMS; 2) checklists to screen for any precautions and risks before rTMS; 3) safety considerations for dosing conventional rTMS; and 4) safety considerations for using rTMS in stroke and traumatic brain injury.
Risk and safety of repetitive transcranial magnetic stimulation: report and suggested guidelines from the International Workshop on the Safety of Repetitive Transcranial Magnetic Stimulation, June 5-7, 1996. [2022]Single-pulse transcranial magnetic stimulation (TMS) is a safe and useful tool for investigating various aspects of human neurophysiology, particularly corticospinal function, in health and disease. Repetitive TMS (rTMS), however, is a more powerful and potentially dangerous modality, capable of regionally blocking or facilitating cortical processes. Although there is evidence that rTMS is useful for treating clinical depression, and possibly other brain disorders, it had caused 7 known seizures by 1996 and could have other undesirable effects. In June 1996 a workshop was organized to review the available data on the safety of rTMS and to develop guidelines for its safe use. This article summarizes the workshop's deliberations. In addition to issues of risk and safety, it also addresses the principles and applications of rTMS, nomenclature, and potential therapeutic effects of rTMS. The guidelines for the use of rTMS, which are summarized in an appendix, cover the ethical issues, recommended limits on stimulation parameters, monitoring of subjects (both physiologically and neuropsychologically), expertise and function of the rTMS team, medical and psychosocial management of induced seizures, and contra-indications to rTMS.
Transcranial magnetic stimulation in the treatment of mood disorder: a review and comparison with electroconvulsive therapy. [2017]To review repetitive transcranial magnetic stimulation (rTMS) as a mode of therapy for depression.