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Author Archives: Robert Pollack

Robert Pollack

About Robert Pollack

Board Certified Psychiatrist in practice over 42 years. Currently focused on Genomic Assessments as part of our treatment assessments and Transcranial Magnetic Stimulation (TMS) therapy along with general adult psychiatry. Currently serve on adjunct faculties of UCF, FSU, USF and Uof F. We currently accept most Insurances.

New therapies like TBS bring better results.

Melissa Banks says she struggled with depression “on and off, but mostly on” since the age of ten. She traces the cause to early life experiences, and while she doesn’t have a personal recollection of the details, her mother has helped fill the gaps in her memory.“My twin brothers were born when I was not quite two,” Melissa shares. “My life until that point had been great. I was part of a young family, was the first daughter and everything was wonderful. Then, when my brothers were born, my mom suffered from postpartum depression. She now had three kids under two. One had food allergies, which they didn’t know anything about in 1974.
“My physical needs got met, but attention and affection were pretty much withdrawn at that age,” Melissa continues. “And then my parents split up when I was nine and divorced when I was ten.”
Melissa’s mother was busy with a full-time job 30 miles from home, and then with her pursuit of a Master’s degree at a college 120 miles away. Melissa took care of her brothers and kept house.
“I was a stay-at-home mom when I got home from school,” she remarks. “I never really felt like a kid. If I needed something, I was adding to the problem. The only way I got positive feedback was to fix other people’s problems.” When she was 14, her mother remarried – and Melissa’s life became more challenging.
“My stepfather was extremely emotionally abusive to me and very jealous of my relationship with my mom,” Melissa discloses. “I was suddenly displaced from their family.” They later moved to a town where Melissa knew no one, leaving her even more isolated. She wanted to live with her father, but he declined.
“The way I dealt with it was by excelling academically,” she remembers, “and I skipped a year of school so I could get out of that house.”
When Melissa left for Spain as an exchange student at 17, her mother and stepfather basically told her, “You don’t have a home to come back to. Have a good life alone.”
In Melissa’s absence, however, her mother saw the family dynamics from a new perspective.
“She realized I wasn’t making all that stuff up about my stepfather because he picked new people to abuse,” Melissa reports.
She and her mother eventually repaired their relationship, and Melissa has learned to coexist with her stepfather.
While that emotional burden has been lifted, physical misery still plagues her. Melissa has fibromyalgia, characterized by chronic muscle pain, fatigue and issues with sleep, memory and mood.
“I’m on a lot of medications to treat it,” she informs. “It’s hard to tell how severe it is because I don’t know what it’s like anymore to feel anything else. Everything hurts all the time.”
As if that wasn’t enough, Melissa’s shoulder ached from a torn ligament and rotator cuff, bursitis and a bone spur, which ended up requiring surgery.
Her struggle with depression also continued, although Melissa didn’t recognize the symptoms because they coincided with her physical ailments, and antidepressants hadn’t helped much in the past.
“There were days I couldn’t get out of bed,” Melissa acknowledges. “I thought about suicide. I didn’t think about it like maybe I should do it, but it was in the back of my mind. What stopped those thoughts from becoming more real was, Who would take care of my two cats?
Her mother lives four hours away, and the rest of the family is up north. Melissa does have close friends but didn’t share her feelings of hopelessness with them.
“How do you express something so overwhelming – that there’s no point in me being alive anymore?” she asks. “That’s not a story you tell someone because there is nothing they can do to fix it.”
Then Melissa’s mother stayed with her after her shoulder surgery, witnessed her behavior and informed her it wasn’t healthy.

21st Century Treatments

In August 2016, the two women came across an article written by Robert Pollack, MD, whose Fort Myers-based practice, Psychiatric Associates of Southwest Florida, embraces emerging therapies for treating depression based on pioneering discoveries about the brain.
“I called them that night, he called me back and we set up an appointment,” Melissa says. “Dr. Pollack got me in that week to do an evaluation.”
He decided her best option for getting well was six infusions of ketamine, an anesthesia drug introduced in the 1960s that acts more quickly than many antidepressants.
While the results aren’t always predictable, Dr. Pollack has found that 72 to 75 percent of his patients with treatment-resistant depression, PTSD, obsessive-compulsive disorder, and bipolar and postpartum depression have a positive response to ketamine.
Unfortunately, a disappointed Melissa wasn’t among them.
Dr. Pollack then suggested theta-burst stimulation (TBS), which uses magnetic pulses to mimic the natural rhythms of activity in the neurons of the brain. He not only hoped to alleviate Melissa’s depression but also to relieve her discomfort from fibromyalgia, which he sees as a related disorder.
“Absolutely there’s a direct connection between the degree of depression and pain perception,” he asserts, “so we really do need to go after both aspects.”
The prescribed TBS regimen was five straight days for two weeks. But after Melissa’s third treatment, Hurricane Irma interrupted that schedule and forced her to evacuate when she lost power at her Naples home. She finally resumed therapy after about three weeks.

No “Magic Bullet”

Despite that gap in her treatment, Melissa reports that her depression is virtually in remission and she no longer feels hopeless or thinks about ending her life.
Her results from a recent PHQ-9 screening questionnaire support her assessment. The PHQ-9rates the frequency of various symptoms in order to measure the level of a patient’s depression, from minimal (zero to four) to severe (20 to 27). Melissa’s test score was a one,
Dr. Pollack confirms.
“Melissa came to us at a point where she couldn’t get out of bed, couldn’t go to work, couldn’t function,” he notes. “Now, she’s going to work and has a significant degree of relief. We were able to get her off a lot of antidepressants.”
While Melissa is enjoying dramatic results from her therapy, Dr. Pollack cautions that treatment of depression and other mental health issues is not an exact science and that there are no “magic bullet” solutions.
“We don’t have all the answers yet,” he expounds. “Eventually, we’re looking at a different direction in the treatment of depression. It’s based more on knowing the patient’s genetics and neurochemistry. We’re going to see gene sequencing approaches to these illnesses very, very soon. What we did two years ago won’t be recognizable two years from now.”
That means mental health professionals must keep up with the ever-changing science by tapping into information available online and from peers.
“This age of psychiatry is truly a collaborative science,” Dr. Pollack emphasizes. “What we all want is to make patients better.”
Melissa is proof that life-changing outcomes are possible for patients and practitioners willing to try innovative therapies until they find what works best.
“Let’s use the tools that we have,” she concludes. “I’m all about being focused on the results.”

February 5, 2018
Robert Pollack

About Robert Pollack

Board Certified Psychiatrist in practice over 42 years. Currently focused on Genomic Assessments as part of our treatment assessments and Transcranial Magnetic Stimulation (TMS) therapy along with general adult psychiatry. Currently serve on adjunct faculties of UCF, FSU, USF and Uof F. We currently accept most Insurances.

Transcranial Magnetic Stimulation vs. Traditional Pharmacotherapy for Major Depressive Disorder

Repetitive transcranial magnetic stimulation (rTMS) is a novel, non-invasive method of activating neural signals through the use of strong, time-varying electromagnetic fields. rTMS is primarily used for patients with treatment-resistant depression. As its reputation has grown, so has its demand. But in the world of health economics and Return on Investment (ROI) ratios, is rTMS a viable option for the millions of people suffering from depression? To date, no such analysis has examined the cost-effectiveness of rTMS as a first line or at least an earlier treatment option over a patient’s lifetime.

To investigate this question, Voight and Leuchter (2017) used Markov simulation modeling to analyze direct costs and quality adjusted life years (QALYs) of rTMS versus medication therapy in patients with newly diagnosed Major Depressive Disorder (MDD) who were age 20-59 and had not improved after a single pharmacotherapy trial. Response and remission rates, quality of life outcomes and life expectancy were culled from the scientific literature. The baseline for treatment costs was derived from federal Medicare reimbursement data. Additional baseline data included QALYs, assessment of superiority, analysis of instrument sensitivity, and lastly, a discount rate of 3% was applied.

The results of this complicated health/economic analysis revealed the superiority of rTMS over currently available pharmacotherapy across the lifespan of adults with MDD, assuming the current costs of treatment remain stable.

Why Does This Matter?

The mortality rate for untreated or undertreated depression is between 15 and 20 percent and growing as addictive disease and chronic pain are increasing, and are bi-directionally associated with MDD.

During a recent visit to China, I heard the simple but inescapable logic of TMS therapy as a first line treatment for depression. Simply stated, the Chinese doctors assert, “Why treat every cell in the body when only the brain causes depression?” So, not only is TMS/rTMS safe and effective and approved by the FDA for refractory depression, but it is also life-saving and life giving. TMS has a very high success rate, and these economic data reveal important cost benefits over other less effective treatments. It is really a no brainer.

Reference:
Voigt J, Carpenter L, Leuchter A. Cost effectiveness analysis comparing repetitive transcranial magnetic stimulation to antidepressant medications after a first treatment failure for major depressive disorder in newly diagnosed patients – A lifetime analysis. PloS one. 2017;12(10): e0186950.

January 26, 2018
Robert Pollack

About Robert Pollack

Board Certified Psychiatrist in practice over 42 years. Currently focused on Genomic Assessments as part of our treatment assessments and Transcranial Magnetic Stimulation (TMS) therapy along with general adult psychiatry. Currently serve on adjunct faculties of UCF, FSU, USF and Uof F. We currently accept most Insurances.

Tolerability and Safety of Theta-Burst TMS in Patients with Major Depression

Abstract

The aim of this open study was to evaluate the safety and tolerability of theta-burst transcranial magnetic stimulation (TBS) and to assess preliminarily its therapeutic efficacy in patients with major depression. A total of 33 patients were assigned to receive one of four TBS protocols for 10 consecutive work days. TBS consisted of triple-pulse 50-Hz bursts given at a rate of 5 Hz to the left or right dorsolateral prefrontal cortex at different stimulation parameters. Severity of depression was assessed by the Hamilton Depression Rating Scale. Our results indicate that TBS as applied in this study is safe and well tolerated in depressed patients and seems to have antidepressant properties. Increase of stimulation parameters is not associated with more side-effects and adds to its therapeutic effect.

Introduction

In the last two decades, repetitive transcranial magnetic stimulation (rTMS) has been studied as a therapeutic tool in several neuropsychiatric disorders, primarily for the treatment of major depression (MD) where it has shown a consistent and reproducible therapeutic effect (Feinsod et al.1998; George et al.19971999; Pascual-Leone et al.1996). Previous studies have demonstrated that left high-frequency (⩾5 Hz) (George et al.2000) and right low-frequency (⩽1 Hz) (Klein et al.1999) rTMS to the prefrontal cortex (PFC) is effective in the treatment of MD. The antidepressant effects of rTMS might be related to its capacity to modulate neuronal plasticity which has been suggested to be altered in depression (Castren, 2005; Normann et al.2007). Results of our previous work (Chistyakov et al.2005a) demonstrated that a positive rTMS treatment response is associated with enhancement of left hemisphere excitability. Furthermore, similar changes in cortical excitability following electroconvulsive therapy (ECT) and pharmacological treatment are correlated with clinical improvement in MD (Chistyakov et al.2005b). The mechanisms of such excitability shifts are unclear, but might be related to long-term potentiation (LTP) and long-term depression (LTD), as shown in animal studies (Hess & Donoghue, 1996). Human studies with rTMS have demonstrated changes in plasticity and cortical function extending beyond the immediate stimulation period. In general, high-frequency rTMS transiently facilitates cortical responses (Pascual-Leone et al.1994) while low-frequency rTMS inhibits cortical excitability (Chen et al.1997). However, these effects have typically been short lasting (10–20 min), of moderate size and variable. Furthermore, the magnitude of the therapeutic effect of rTMS is modest with a small to moderate effect size. This calls for the design of more effective rTMS paradigms that will achieve a more robust antidepressant effect.

Theta-burst electrical stimulation (TBS) has long been known as a highly effective method to induce LTP and LTD in animals. Recently, Huang & Rothwell (2004) and Huang et al. (2005) reported safe application of TBS without noticeable adverse effects in humans, using rTMS techniques. Three magnetic pulses with an inter-stimulus interval of 20 ms (50 Hz) were applied repeatedly every 200 ms representing the theta rhythm of 5 Hz. This stimulation method produced more robust and enduring changes in cortical excitability (Huang et al.200720082009; Ishikawa et al.2007; Katayama & Rothwell, 2007). The application of this paradigm to humans allows induction of long-lasting excitatory and inhibitory changes in cortical excitability, simply by varying the stimulus sequence. When applied continuously for 40 s over the motor cortex, referred as continuous theta-burst stimulation (cTBS), theta-burst rTMS causes a suppression of motor-evoked potentials lasting up to several hours. In contrast, the interruption of this sequence every 2 s for 8 s results in a long-lasting facilitation and this stimulation paradigm was termed intermittent TBS (iTBS) (Huang et al.2005). These changes were shown to be consistent and robust across subjects. Thus theta-burst TMS seems to offer an advantage to some of the shortcomings of conventional rTMS and might be more effective than currently used rTMS treatments.

The aim of the present study was 2-fold: (1) to evaluate the safety and tolerability of TBS of different type, intensity and duration; (2) to assess preliminarily therapeutic efficacy of TBS in patients with MD.

Materials and methods

Subjects

A total of 33 patients were recruited from the population of MD patients hospitalized for treatment of their depression. All provided written informed consent to participate in the study, which was approved by Rambam Medical Center Ethics Committee. Patients aged 20–75 yr were included in the trial if they met DSM-IV criteria for MD and were capable of providing informed consent and cooperate sufficiently in the clinical and neurophysiological assessment. Exclusion criteria were: (1) suicidal risk, (2) evidence of a disease that might affect central and peripheral nerve conduction, (3) seizure disorder, (4) history of head trauma in the last year, (5) systemic uncontrolled disease, (6) implanted electronic devices (e.g. pacemaker, cochlear implant, deep brain stimulator) or metallic implants and (7) drug or alcohol abuse in the last 6 months.

All patients received at least one medication trial as outpatients and were hospitalized due to lack of response or deterioration of their clinical condition. Patients were invited to participate in the study soon after their admission and were maintained on their previous medications throughout the course of TBS treatment. Out of 33 patients, 12 were receiving antidepressants, mostly SSRIs or SNRIs, and 20 were on a combination of antidepressants and mood stabilizers. One patient received only mood stabilizers.

Initially, 13 patients were randomized to receive one of the two treatment conditions: (1) iTBS (hereafter iTBS1200) to the left dorsolateral prefrontal cortex (DLPFC) (n=7); (2) continuous TBS (hereafter cTBS1200) to the right DLPFC (n=6). The intensity of stimulation was 90% of the active motor threshold (aMT). Each treatment session consisted of 600 stimuli repeated twice daily (1200 stimuli per day) for 10 consecutive work days. This protocol was termed ‘short TBS’. As evident from these 13 patients, right-sided cTBS appeared to have a more prominent antidepressant action. Thus, right-sided stimulation was further amended in six patients who received 900 stimuli per session at 100% aMT intensity applied twice daily (a total of 1800 stimuli per day, hereafter cTBS1800), and in 14 additional patients who received 1800 stimuli per session delivered in two consecutive trains of 900 stimuli each separated by a 30-min interval and repeated twice daily (a total of 3600 stimuli per day, hereafter cTBS3600). These protocols were termed ‘amended TBS’.

TBS treatment

TBS was applied through a 70-mm figure-of-eight coil (peak magnetic field 2.2 T) connected to a Magstim Super Rapid2 (Magstim Company Ltd, UK) magnetic stimulator with four booster modules as well as an integrated two-channel EMG amplifier and system acquisition software. The system enables recording of motor-evoked potentials for threshold determination as well as programming of different modes of stimulation including TBS protocols. The coil was placed tangentially to the scalp with the handle pointed backwards, 5 cm anterior to the site optimal for producing the motor response in the contralateral abductor pollicis brevis (APB) muscle. As originally described by Huang et al. (2005), TBS consisted of triple-pulse 50-Hz bursts given at a rate of 5 Hz (i.e. 200 ms between each burst). For iTBS, a 2-s TBS train was repeated every 10 s. cTBS was applied as a single uninterrupted TBS train. As previously mentioned, the stimulus intensity was 90% aMT in patients who received 1200 stimuli per day (short TBS protocol) and 100% aMT in patients who received 1800 and 3600 stimuli per day (amended TBS protocol). However, due to limitations of the stimulator the maximal TBS intensity which could be applied in the amended TBS protocol was 51% of the maximal stimulator output. For this reason, in seven patients (two who received cTBS1800 and five who received cTBS3600) whose aMT was higher than 51% of the maximal stimulator output, the actual stimulus intensity was 92.3±2.5% aMT.

Patients were seated in an armchair and earplugs were used during the treatment session.

Assessment of motor thresholds

The resting motor threshold (rMT) was defined as the lowest stimulus intensity capable of eliciting in the relaxed APB muscle at least five motor responses with amplitude of at least 50 µV in a series of 10 consecutive trials of single-pulse TMS. aMT was measured during a voluntary isometric contraction of the contralateral APB with the force level of about 20% of maximal EMG. It was defined as the minimum stimulus intensity required to produce motor responses >100 µV in five consecutive single-pulse TMS trials.

Clinical assessment

Severity of depression was assessed by the HAMD and the Clinical Global Impression (CGI) scale. Ratings were performed by a trained psychiatrist at baseline and weekly thereafter. Marked clinical improvement was defined as a reduction of ⩾50% in HAMD.

Statistical procedures

The effects of TBS on depression scores were analysed using repeated-measures ANOVA with group (iTBS1200, cTBS1200, cTBS1800, cTBS3600) as the between-subject factor, and time (baseline, after 1 wk, after 2 wk) as the inter-subject term. Between-group comparisons of the frequencies of categorical variables were carried out by the χ2 test. The results were considered significant if p<0.05.

Results

[To Read the Full Study Please Click Here] or [Download the PDF HERE]

January 11, 2018
Robert Pollack

About Robert Pollack

Board Certified Psychiatrist in practice over 42 years. Currently focused on Genomic Assessments as part of our treatment assessments and Transcranial Magnetic Stimulation (TMS) therapy along with general adult psychiatry. Currently serve on adjunct faculties of UCF, FSU, USF and Uof F. We currently accept most Insurances.