APNA 28th Annual Conference Session 1024: October 22, 2014

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1 Therapeutic Neuromodulation: Implications for Psychiatric Mental Health (PMH) Nurses Mary Rosedale PhD, PMHNP BC Donna Ecklesdafer, MSN, BSN, RN Dawn Miller, BSN, RN Julie Ann Mulder MS, BSN, BS, RN BC 1 Disclosures Mary Rosedale: Edith L. Fisch Award for Innovation in Neurostimulation, New York University, School of Medicine NYU College of Nursing Pless Center for Nursing Research CTSI Grant # 5UL1RR Supported in part by grant 1UL1RR from the National Center for Research Resources, National Institutes of Health No Conflict of Interest to disclose for the other presenters. Objectives Objective 1 Examine the neurobiology of brain stimulation Objective 2 Explore the safety and efficacy of Deep Brain Stimulation (DBS), Electroconvulsive Therapy (ECT), Transcranial Magnetic Stimulation (TMS), Deep TMS, Magnetic Seizure Therapy (MST), Vagus Nerve Stimulation (VNS) and Transcranial Direct Current Stimulation (tdcs) Objective 3 Explain the role of PMH nurses in practice, education and research in neuromodulation The Brain as an Electrical and Chemical Organ 100 billion neurons 100 trillion connections Interaction is a combination of electrical and chemical interaction An electrical impulse along an axon Excitatory or inhibitory Threshold= The level of stimulation needed to trigger an action potential 4 5 Brain Stimulation Techniques Electroconvulsive Therapy (ECT) Vagus Nerve Stimulation (VNS) Repetitive Transcranial Magnetic Stimulation (rtms) Deep Brain Stimulation (DBS) Epidural Cortical Stimulation (EpCS) Transcranial Direct Current Stimulation (tdcs) 6 Ecklesdafer, Rosedale, Miller, Mulder 1

2 Survey of the major neurotransmitters excitatory presynaptic neuron Inhibitory GABA presynaptic neuron Inhibitory neurotrans mission prevents excitation of the postsynaptic neuron Postsynaptic neuron inhibitory Mayberg, HS, 1999 Drevets, WC 2001 Ecklesdafer, Rosedale, Miller, Mulder 2

3 Depression Cerebral blood flow & Metabolism Hippocampal volume Serotonin Dopamine Neurogenesis & Neuroplasticity Neuroplasticity The ability of the neural pathways and synapses to adapt to stimuli by reorganizing structurally and functionally. 13 Neurogenesis The birth of new neurons mostly known to occur in the dentate gyrus of the hippocampal formation. 14 ECT Plasma prolactin levels Thyrotropin releasing hormone (TRH) TRH receptor function Brain derived neurotrophic factor (BDNF) TMS Cerebral blood flow in the prefrontal & paralimbic areas Dopamine Serotonin Thyroid stimulating hormone (TSH) Glutamate levels GABA Electroconvulsive Therapy (ECT) Donna Ecklesdafer, MSN, BSN, RN ECT Clinic Manager Pine Rest Christian Mental Health Services Ecklesdafer, Rosedale, Miller, Mulder 3

4 Diagnoses Diagnoses Major Depression (+/- psychosis) Other diagnoses Bipolar Depression and Mania Schizoaffective Catatonia 19 Neuroleptic Malignant Syndrome Dementia with underlying mood disorder Current research project Short-term Efficacy and Cognitive Side Effects of Acute Electroconvulsive Therapy for Agitation and Aggression in Dementia 20 Life Saving Treatment Actively Suicidal Rapid Response Needed Suicide (American Association of Suicidology) Completed suicide: 38,364 cases reported in Suicide (American Association of Suicidology) Average of 1 person every 13.7 minutes killed themselves Average of 1 elderly person every 1 hour and 28 minutes killed themselves Average of 1 young person every 1 hour and 54 minutes killed themselves Adding the 274 suicides below age 15, the rate would be 1 young person every 1 hour and 48 minutes 22 Suicide (American Association of Suicidology) Suicide is the 10 th ranking cause of death in U.S. Homicide ranks 16th Suicide is the 3 rd highest cause of death for young (ages 15 24) 1 st accidents: 12,951 2 nd homicide: 4,678 3 rd suicide: 4, Improvements in ECT Medications Anesthesia Muscle Relaxant Oxygenation Administration of oxygen Monitor oxygen saturation 24 Ecklesdafer, Rosedale, Miller, Mulder 4

5 Improvements in ECT Stimulus Electrode Placements Type of electricity brief pulse wave Seizure monitoring Stimulus dosing Bi-temporal Right Unilateral Bifrontal Ultra brief pulse Seizure Monitoring Seizure length seconds Tonic/Clonic (Peripheral seizure) ECT Treatments Acute Series 3 times each week Typically 6 12 treatments Improvements seen after 4 6 treatments Tachycardia Electroencephalogram (EEG) (Central seizure) 27 Maintenance Weekly to monthly Can prevent inpatient stays 80% of patients relapse after ECT with no follow up of medications or maintenance ECT 28 Seizure Threshold Seizure Threshold Medications that can change seizure threshold Other influences on seizure threshold Lithium Benzodiazepines Mood stabilizers Antipsychotics 29 Age Gender Electrode placement Hyperventilation Dehydration Sleep 30 Ecklesdafer, Rosedale, Miller, Mulder 5

6 Seizures Parasympathetic discharge Anesthesia Anesthetic Brevital or methohexital Sympathetic discharge Etomidate Muscle relaxant succinylcholine (anectine) Potential rebound parasympathetic discharge 31 Depolarizing muscle relaxant Most common cause of muscle soreness 32 Potential Mechanisms of Action Decreases frontal cortical connectivity Neurotransmitter theory Anticonvulsant theory Benefits of ECT Improved mood Increased pleasure More restful sleep Better appetite More positive attitude Less agitation Increased sexual interest More energy Clearer thinking More hope Potential Side Effects Contraindications Headache and muscle aches No absolute contraindications Nausea Unsteady on feet High risk Risk versus benefit Confusion Potential short term and/or long term memory loss 35 Mortality Less than for childbirth 36 Ecklesdafer, Rosedale, Miller, Mulder 6

7 Pre-ECT Workup ECT Procedure Psychiatric referral Basic Metabolic Profile Electrocardiogram History & Physical medical clearance Inpatient versus Outpatient Risk/Benefit Ratio Education Informed Consent 37 Patient and Family rating scale Assessment of patient Intravenous line placement Anesthesia and muscle relaxant Brief electrical stimulus Monitor seizure activity Post Anesthesia Care Unit Vitals stable discharge 38 Transcranial Magnetic Stimulation (TMS) Therapy Transcranial Magnetic Stimulation (TMS) Therapy TMS is a non invasive treatment for Major Depressive Disorder (MDD) in adult patients FDA approved in October 2008 for MDD with one failed antidepressant trial 39 FDA approved in April 2014 for MDD for those who have failed to benefit from any number of antidepressant trials Off label uses: treatment of anxiety disorders, Bipolar Disorder, Post Traumatic Stress Disorder, chronic pain, fibromyalgia, eating disorders, and Parkinson s Disease 40 TMS Therapy Stimulates cortical neurons by delivering magnetic pulses to a specific area of the brain Utilizes a magnetic field generated by a treatment coil applied to the head, usually tesla Neuronetics TMS NeuroStar machine generates 0.5 tesla For comparison, 3.0 T is the strength of magnetic field generated by most medical Magnetic Resonance Imaging (MRI) systems 41 How TMS Works TMS is based on two electromagnetic principles: 1. Ampere s Law: magnetic field generated using alternating an electrical current 2. Faraday s Law: electrical current generated using an alternating magnetic field Electricity passes through the metal coil which is placed directly against the head over the Dorsolateral Prefrontal Cortex (DLPFC) 42 Ecklesdafer, Rosedale, Miller, Mulder 7

8 How TMS Works Electric energy Results in within insulated coil depolarization of induces magnetic nerve cells causing fields release of Magnetic fields neurotransmitters penetrate the cranium cm below the device Magnetic fields induce electric current in the brain 43 Dorsolateral Prefrontal Cortex (DLPFC) TMS produces its effect through electrical stimulation of the DLPFC; this is the area of the brain believed to be responsible for regulating mood. 44 Early Transcranial Magnetic Stimulation 45 Identifying TMS Treatment Location Coil is applied to the Primary Motor Cortex to initiate a thumb twitch response; this is called the Motor Threshold (MT) MT determines the energy required to effectively treat depression and helps identify the location of the DLPFC Coil is placed 5.5 cm anterior to the location of the MT 46 Primary Motor Strip and Homunculus 47 TMS Administration TMS sessions: 1 per day for 4 6 weeks (typically Monday through Friday) Typical series is 30 treatments Treatments last approximately 40 minutes Patient positioning & Motor Threshold is determined Recommended Intensity: 120% of MT Frequency: pulses per second (10 Hz or 1 Hz) Treatment train: 4 seconds of stimulation with 26 seconds of no stimulus; 3000 total pulses per treatment 48 Ecklesdafer, Rosedale, Miller, Mulder 8

9 NeuroStar TMS Therapy System Treatment Coil Display Brainsway TMS System Deep TMS (dtms) Magnetic field penetrates cm Senstar Treatment Link Mobile Console Patient Selection for TMS Absolute Contraindications: Patients with MDD who have failed trials of antidepressant medications at or above minimally effective dose, for a minimal duration (at least 4 weeks) in the current episode of MDD Patients who have been carefully screened for any of the absolute contraindications to receiving TMS Patients who are willing and able to commit to treatments five days a week for 4 6 weeks 51 Seizure disorder or history of seizures (except those induced by ECT) Intracranial devices (cerebrospinal fluid shunts, aneurysm clips, cochlear implants, deep brain stimulation leads, etc.) Carotid or cerebral stents Space occupying brain lesions Evidence of increased intracranial pressure 52 Absolute Contraindications: Relative Contraindications Vagus nerve stimulator Ferromagnetically ocular implants Magnetically activated dental implants Facial tattoos or permanent makeup with metallic ink less than or equal to 30cm from the coil Pellets, bullets, or metallic fragments less than or equal to 30cm from coil 53 Dementia & other degenerative neurological conditions (i.e. Parkinson s, Multiple Sclerosis, etc.) Unstable medical conditions Chronic or acute psychotic disorders (i.e. Schizophrenia, Schizophreniform, Schizoaffective disorders, etc.) 54 Ecklesdafer, Rosedale, Miller, Mulder 9

10 Relative Contraindications Clinical Considerations Serious co morbid psychiatric conditions (i.e. psychotic depression, active substance abuse, etc.) History of cerebrovascular accident Implantable automatic defibrillator or cardiac pacemaker History of significant head injury resulting in loss of consciousness greater than 5 minutes and/or hospitalization 55 Performed as an outpatient or inpatient procedure Patient is awake, alert during treatment Treatment lasts about 40 minutes, patient resumes normal activity afterwards Many TMS patients continue to take psychotropic medications Several insurance companies provide TMS coverage, either as part of their policy or on a case by case basis 56 TMS Side Effect Profile TMS Side Effect Profile Common Side Effects Scalp discomfort, tenderness at coil placement site Headache, may be managed with an over the counter analgesic Facial pain, muscle twitching These side effects were graded as mild to moderate and dissipated rapidly with time. 57 Rare Side Effect Risk of generalized seizure: 1 in 30,000 treatments or 0.003% To mitigate this risk, patients are carefully screened for seizure history & any conditions/situations that have the potential to alter seizure threshold (i.e. tricyclic antidepressants, neuroleptics, secondary conditions that alter electrolyte imbalance or lower seizure threshold) % TMS Remission Rates: Neuronetics Trial and NIMH OPT TMS Study Response, Remission, Non Response Rates for TMS pts at WRNMMC Response 50% reduction in baseline mood scale score (PHQ 9, QIDS SR): 44.4% of those who responded 60 5% of 4 met criteria for full remission of MDD symptoms Remission Full resolution of depressive symptoms (PHQ 9 score < 5, QIDS SR < 6) Active Sham Neuronetics Active Sham OPT TMS Non Response rate at WRNMMC after 20+ TMS sessions: 44.4% Ecklesdafer, Rosedale, Miller, Mulder 10

11 TMS Roles TMS machine is a class II device prescribed by a psychiatrist (but each state regulates prescriptive authority which includes Nurse Practitioners) Attending psychiatrist oversees initial patient MT determinations, treatment parameter definitions, & overall TMS treatment course planning Ideally, treatment is administered by a RN who has the ability to manage seizures, monitor psychological status, & has proper training on the TMS device 61 Role of the PMH Nurse in TMS PMH nurse is present throughout treatment, allowing for close monitoring of day to day changes in the patient s condition Administering psychiatric scales to monitor progress Administers daily treatment within prescribed parameters; assures proper patient positioning & proper coil placement Continuously monitors for signs of impending seizure Coordinates care with outpatient providers Crisis intervention as needed (psychiatric and medical) 62 TMS Manufacturers TMS Manufacturers Brainsway (Israel), Neuronetics Inc., Currently the only FDA approved devices are manufactured by Brainsway and Neuronetics. 63 CR Tech (Seoul, South Korea) Magstim Company, Ltd. (Whitland, UK) ww.magstim.com MAG&MORE GmbH, (Munich, Germany) Mcube Technology Co., Ltd. (Seoul, South Korea) Medtronic Dantec NeuroMuscular (Skovlunde, Denmark) Neuralieve (California, USA) Nexstim (Finland) Schwarzer (München, Germany) 64 References 1. Baeken C, De Raedt R. Neurobiological mechanisms of repetitive transcranial magnetic stimulation on the underlying neurocircuitry in unipolar depression. Dialogues in Clinical Neuroscience 2011; 13(1): Barker AT, Jalinous R. Non invasive magnetic stimulation of human motor cortex. Lancet 1985 (May 11, 1985): Zangen, A., Roth, Y., Voller, B., Hallett, M Transcranial magnetic stimulation of deep brain regions: evidence for efficacy of H coil. Journal of Neurophysiology 2005; 116 (4): Dell Osso B, Camuri G, Castellano F, Vecchi V, Benedetti M, Bortolussi S, Altamura AC. Meta review of metanalytic studied with repetitive transcranial magnetic stimulation (rtms) for the treatment of major depression. Clinical Practice & Epidemiology in Mental Health 2011; 7: Epilepsy Foundation of America, Inc Managing seizures: Information for caregivers. 6. George MS, Belmaker RH (editors). Transcranial Magnetic Stimulation in Clinical Psychiatry. Arlington, VA: American Psychiatric Publishing, Higgins ES, George MS. Brain Stimulation Therapies for Clinicians. Washington, DC: American Psychiatric Publishing, Inc., Deep & Cortical Brain Stimulation 66 Medtronic NeuroPace Ecklesdafer, Rosedale, Miller, Mulder 11

12 Bilateral Epidural Prefrontal Cortical Stimulation for TRD Cognition, executive control and integration of emotion: 2 complimentary networks VN S 69 Overlapping Paradigm Shifts in Nursing and Brain Stimulation 50 years is needed to make a paradigm shift In the past 6 decades, Nursing has been transformed from an occupation where nurses do to and for patients, to a profession where nurses work with patients For more than 7 decades, nurses have provided specialized care for ECT patients Brain stimulation therapies are a new therapeutic class and Psychiatric Nursing field 70 Cyberonics, Inc., Houston, TX The Science is Moving at Accelerated Rate: Changing Practice and Knowledge Development tdcs for Depression (Rigonnati et al., 2008 & Fregni et al., 2006 Mayberg et al Ecklesdafer, Rosedale, Miller, Mulder 12

13 Transcranial Direct Current Stimulation in HIV-Infected, Depressed Persons Safety,Tolerability and Feasibility of tdcs for HIV+ Persons Racial and Ethnic Minorities with MDD tdcs was an Safe, effective and tolerable treatment in 7 HIV patients with co morbid major depression and associated with significant (P <.05) decreases in HAMD 24 and MADRAS scores (Rosedale & Knotkova, in review) 73 sessiopfc Phoressor II 850 PM using 2 electrodes (36cm 2 ) placed over F3 position of EEG system and the contralateral supraorbital region. Recruit racial/ethnic minorities HamD 24 and MADRAS Cytokine assays Analyze characteristics of completers/ non-completers Conduct qualitative interviews to incorporate subject input in future patient-centered treatment protocols Open label, 2 week block of tdcs (Baker, Rorden, & Fridriksson, 2010; Stroke) 74 A Treatment Wish List There is a very specific kind of pain to depression and it became less vicious. It was not that pain changed: the perception of pain changed (Rosedale, Lisanby & Malaspina, 2009) An evidence-based treatment for depression and pain Focus and dose that can be personalized Faster onset than medications Acceptable to those who cannot tolerate medications due to side effects, med interactions and comorbidities Adjuvant treatment for those reporting partial relief from other treatments (safely combined/optimizing response) Feasible for patients with low performance status (minimal patient effort or attention) Clinically tested in racial and ethnic minorities Well tolerated, brief, safe, easy to administer and inexpensive Key Issues: Reclassification of ECT by FDA and APNA s Position Statement ECT as evidence-based practice Unparalleled efficacy of ECT and dangers of limiting access Evolution of ECT and Brain Stimulation Misinformation and stigma of psychiatric conditions and treatments Key Issues at FDA hearings APNA s Vital Leadership Role and Position How History of Brain Stimulation Shapes Psychiatric Nursing s Future Advancing Evidence-based practice Combining Psychotherapeutic Treatments Combining Qualitative and Qualitative Approaches Treating new populations Advocating for Our Patients Influencing Public Policy Ecklesdafer, Rosedale, Miller, Mulder 13

14 APA ECT Task Force: APNA Consultation on Nurse s Role Second edition (2001) Third edition (2013) Evidence-based Nursing Practice and APN roles Accurately representing the wealth of psychiatric nursing expertise and the contributions of nursing profession 79 Life Long Neurogenesis: Olfactory System Olfactory Epithelium Culture Olfactory Neurons Gene Expression Studies Potential for Stem cells Hippocampal Dentate Gyrus Coronal and sagital 7T 100 micron cell layer Hippocampus 80 Translational Neuroscience Research Clinical Research Epidemiology Psychiatric Nursing and Brain Stimulation: Back to the Future Basic Science Animal Models Ecklesdafer, Rosedale, Miller, Mulder 14

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