Exercise + TMS for Treatment Resistant Depression
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Butler Hospital
Disqualifiers: Pregnancy
No Placebo Group
Trial Summary
What is the purpose of this trial?Given the growing evidence that aerobic increases cortical excitability and promotes neuroplasticity, the scientific premise for its potential priming effect on the brain is strong. Combining AE with rTMS may produce a neural environment optimized for a robust physiological effect of rTMS, thereby leading to improved depression outcomes. With positive findings, this study would provide preliminary support for an innovative, safe and feasible approach for improving outcomes for this significant public health problem.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.
What data supports the effectiveness of the treatment Exercise + TMS for Treatment Resistant Depression?
Research shows that aerobic exercise can significantly reduce depression symptoms, and transcranial magnetic stimulation (TMS) has been effective in treating major depressive disorder, especially when other treatments haven't worked. Combining these approaches may offer a promising option for those with treatment-resistant depression.
12345Is exercise safe for people with depression?
Exercise, including aerobic exercise, is generally considered safe for people with depression and can be an effective addition to other treatments. While more high-quality studies are needed, current research suggests that exercise can be safely integrated into treatment plans for depression.
26789How does the Exercise + TMS treatment differ from other treatments for treatment-resistant depression?
The Exercise + TMS treatment is unique because it combines physical exercise with transcranial magnetic stimulation (TMS), a non-invasive technique that uses magnetic fields to stimulate nerve cells in the brain. This combination may offer a novel approach by potentially enhancing the effects of TMS, which is already used for treatment-resistant depression, through the added benefits of exercise.
3451011Eligibility Criteria
This trial is for adults over 18 with treatment-resistant depression who are approved for standard TMS therapy at Butler Hospital's clinic and can safely do moderate-intensity exercise.Inclusion Criteria
Able to safely engage in moderate-intensity aerobic exercise (determined by a study physician)
I am over 18 and approved for TMS therapy at Butler Hospital.
Exclusion Criteria
Currently pregnant or plans to become pregnant in the next 6 weeks
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive 30 sessions of rTMS treatment, with either aerobic exercise or video watching prior to each session
6 weeks
30 visits (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The study tests if doing aerobic exercise before receiving repetitive Transcranial Magnetic Stimulation (rTMS) improves outcomes in treating major depressive disorder compared to just watching videos.
2Treatment groups
Experimental Treatment
Group I: Video ConditionExperimental Treatment1 Intervention
In this condition, participants will be asked to sit and watch various documentaries or educational videos on topics NOT related to physical activity. These will last approximately 20 minutes and will occur before each TMS session.
Group II: Aerobic ExerciseExperimental Treatment1 Intervention
Exercise sessions will be 20 minutes of moderate-intensity aerobic exercise on a treadmill. A treadmill is located on D1A within the space shared by the Butler Hospital TMS Clinic and the COBRE-support Neuromodulation Research Facility. A research staff member will monitor their heart rate and blood pressure to ensure safety and that activity is occurring at a moderate intensity (i.e., 64-76% of age predicted maximal heart rate). Participants will be asked to rate their affect and rating of perceived exertion (RPE) during exercise sessions. Sessions will include a 5-min warm-up and a 5-min cool-down to ensure safe exercise procedures. Participants will be asked to answer questions about affect before, during, and after exercise. These sessions will be supervised (i.e., they provide onsite coverage) by an exercise physiologist or medical staff member (e.g., nurse or physician) to ensure safety.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Butler HospitalProvidence, RI
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Who Is Running the Clinical Trial?
Butler HospitalLead Sponsor
National Institute of General Medical Sciences (NIGMS)Collaborator
References
Transcranial magnetic stimulation in the acute treatment of major depressive disorder: clinical response in an open-label extension trial. [2019]This report describes the results of an open-label extension study of active trans-cranial magnetic stimulation (TMS) in medication-resistant patients with major depressive disorder who did not benefit from an initial course of therapy in a previously reported 6-week, randomized controlled study of active versus sham TMS.
Aerobic exercise for adult patients with major depressive disorder in mental health services: A systematic review and meta-analysis. [2019]Although exercise is associated with depression relief, the effects of aerobic exercise (AE) interventions on clinically depressed adult patients have not been clearly supported. The purpose of this meta-analysis was to examine the antidepressant effects of AE versus nonexercise comparators exclusively for depressed adults (18-65 years) recruited through mental health services with a referral or clinical diagnosis of major depression. Eleven e-databases and bibliographies of 19 systematic reviews were searched for relevant randomized controlled clinical trials. A random effects meta-analysis (Hedges' g criterion) was employed for pooling postintervention scores of depression. Heterogeneity and publication bias were examined. Studies were coded considering characteristics of participants and interventions, outcomes and comparisons made, and study design; accordingly, sensitivity and subgroup analyses were calculated. Across 11 eligible trials (13 comparisons) involving 455 patients, AE was delivered on average for 45 min, at moderate intensity, three times/week, for 9.2 weeks and showed a significantly large overall antidepressant effect (g = -0.79, 95% confidence interval = -1.01, -0.57, P < 0.00) with low and nonstatistically significant heterogeneity (I2 = 21%). No publication bias was found. Sensitivity analyses revealed large or moderate to large antidepressant effects for AE (I2 ≤ 30%) among trials with lower risk of bias, trials with short-term interventions (up to 4 weeks), and trials involving individual preferences for exercise. Subgroup analyses revealed comparable effects for AE across various settings and delivery formats, and in both outpatients and inpatients regardless symptom severity. Notwithstanding the small number of trials reviewed, AE emerged as an effective antidepressant intervention.
Repetitive transcranial magnetic stimulation (rTMS) for treatment-resistant major depression (TRMD) Veteran patients: study protocol for a randomized controlled trial. [2018]Evaluation of repetitive transcranial magnetic stimulation (rTMS) for treatment-resistant major depression (TRMD) in Veterans offers unique clinical trial challenges. Here we describe a randomized, double-blinded, intent-to-treat, two-arm, superiority parallel design, a multicenter study funded by the Cooperative Studies Program (CSP No. 556) of the US Department of Veterans Affairs.
Left prefrontal transcranial magnetic stimulation for treatment-resistant depression in adolescents: a double-blind, randomized, sham-controlled trial. [2022]Treatment-resistant depression (TRD) is prevalent and associated with a substantial psychosocial burden and mortality. There are few prior studies of interventions for TRD in adolescents. This was the largest study to date examining the feasibility, safety, and efficacy of 10-Hz transcranial magnetic stimulation (TMS) for adolescents with TRD. Adolescents with TRD (aged 12-21 years) were enrolled in a randomized, sham-controlled trial of TMS across 13 sites. Treatment resistance was defined as an antidepressant treatment record level of 1 to 4 in a current episode of depression. Intention-to-treat patients (n = 103) included those randomly assigned to active NeuroStar TMS monotherapy (n = 48) or sham TMS (n = 55) for 30 daily treatments over 6 weeks. The primary outcome measure was change in the Hamilton Depression Rating Scale (HAM-D-24) score. After 6 weeks of blinded treatment, improvement in the least-squares mean (SE) HAM-D-24 scores were similar between the active (-11.1 [2.03]) and sham groups (-10.6 [2.00]; P = 0.8; difference [95% CI], - 0.5 [-4.2 to 3.3]). Response rates were 41.7% in the active group and 36.4% in the sham group (P = 0.6). Remission rates were 29.2% in the active group and 29.0% in the sham group (P = 0.95). There were no new tolerability or safety signals in adolescents. Although TMS treatment produced a clinically meaningful change in depressive symptom severity, this did not differ from sham treatment. Future studies should focus on strategies to reduce the placebo response and examine the optimal dosing of TMS for adolescents with TRD.
An accelerated course of TMS using intermittent theta burst for veterans with major depressive disorder: A case series. [2023]Transcranial magnetic stimulation (TMS) is a neuro-modulation technique for treatment-resistant major depressive disorder (MDD). Standard TMS protocols for MDD involve once-daily treatment for 6 to 9 weeks. We report a case series of an accelerated TMS protocol for outpatient MDD treatment.
The effects of aerobic, resistance, and meditative movement exercise on sleep in individuals with depression: protocol for a systematic review and network meta-analysis. [2023]The main objective of this review is to assess the effects of aerobic, resistance, and meditative movement exercise on sleep quality in patients with unipolar depression. A secondary goal is to ascertain the effects on sleep duration, sleepiness, daytime functioning, use of hypnotics, and adverse events.
Clinical and neuroimaging correlates in a pilot randomized trial of aerobic exercise for major depression. [2023]Aerobic exercise (AE) combined with pharmacotherapy is known to reduce depressive symptoms; however, studies have not focused on long-term AE for volumetric changes of brain regions (amygdala, thalamus, and nucleus accumbens [NAcc]) linked to the control of affective responses and hopelessness in individuals with major depression (MD). In addition, AE with motor complexity (AEMC) would be more effective than AE in causing brain plasticity. We compared the effects of 24 weeks of AE and AEMC combined with pharmacotherapy on clinical and volumetric outcomes in individuals with MD.
Comparative Benefits and Harms of Complementary and Alternative Medicine Therapies for Initial Treatment of Major Depressive Disorder: Systematic Review and Meta-Analysis. [2022]To report the comparative benefits and harms of exercise and complementary and alternative medicine (CAM) treatments with second-generation antidepressants (SGA) for major depressive disorder (MDD).
Exercise as an add-on strategy for the treatment of major depressive disorder: a systematic review. [2022]Antidepressants are currently the treatment of choice for major depressive disorder (MDD). Nevertheless, a high percentage of patients do not respond to a first-line antidepressant drug, and combination treatments and augmentation strategies increase the risk of side effects. Moreover, a significant proportion of patients are treatment-resistant. In the last 30 years, a number of studies have sought to establish whether exercise could be regarded as an alternative to antidepressants, but so far no specific analysis has examined the efficacy of exercise as an adjunctive treatment in combination with antidepressants. We carried out a systematic review to evaluate the effectiveness of exercise as an adjunctive treatment with antidepressants on depression. A search of relevant papers was carried out in PubMed/Medline, Google Scholar, and Scopus with the following keywords: "exercise," "physical activity," "physical fitness," "depressive disorder," "depression," "depressive symptoms," "add-on," "augmentation," "adjunction," and "combined therapy." Twenty-two full-text articles were retrieved by the search. Among the 13 papers that fulfilled our inclusion criteria, we found methodological weaknesses in the majority. However, the included studies showed a strong effectiveness of exercise combined with antidepressants. Further analyses and higher quality studies are needed; nevertheless, as we have focused on a particular intervention (exercise in adjunction to antidepressants) that better reflects clinical practice, we can hypothesize that this strategy could be appropriately and safely translated into real-world practice.
Transcranial Magnetic Stimulation for Treatment-Resistant Depression: An Interactive Self-Learning Module. [2020]The use of transcranial magnetic stimulation (TMS) has become increasingly prevalent in psychiatry. A growing body of literature supports its use with treatment-resistant depression (TRD), and this indication has gained FDA approval. However, new psychiatry residents often have little exposure to or understanding of TMS.
Repetitive Transcranial Magnetic Stimulation for the Treatment of Resistant Depression: A Scoping Review. [2022]Treatment-resistant depression (TRD) is associated with significant disability, and due to its high prevalence, it results in a substantive socio-economic burden at a global level. TRD is the inability to accomplish and/or achieve remission after an adequate trial of antidepressant treatments. Studies comparing repetitive transcranial magnetic stimulation (rTMS) with electroconvulsive therapy (ECT) and pharmacotherapy have revealed evidence of the therapeutic efficacy of rTMS in TRD. These findings suggest a crucial role for rTMS in the management of TRD. This article aims to conduct a comprehensive scoping review of the current literature concerning the use of rTMS and its therapeutic efficacy as a treatment modality for TRD. PubMed, PsycINFO, Medline, Embase, and Cinahl were used to identify important articles on rTMS for TRD. The search strategy was limited to English articles within the last five years of data publication. Articles were included if they reported on a completed randomized controlled trial (RCT) of rTMS intervention for TRD. The exclusion criteria involved studies with rTMS for the treatment of conditions other than TRD, and study and experimental protocols of rTMS on TRD. In total, 17 studies were eligible for inclusion in this review. The search strategy spanned studies published in the last five years, to the date of the data search (14 February 2022). The regional breakdown of the extracted studies was North American (n = 9), European (n = 5), Asian (n = 2) and Australian (n = 1). The applied frequencies of rTMS ranged from 5 Hz to 50 Hz, with stimulation intensities ranging from 80% MT to 120% MT. Overall, 16 out of the 17 studies suggested that rTMS treatment was effective, safe and tolerated in TRD. For patients with TRD, rTMS appears to provide significant benefits through the reduction of depressive symptoms, and while there is progressive evidence in support of the same, more research is needed in order to define standardized protocols of rTMS application in terms of localization, frequency, intensity, and pulse parameters.