The aim of this petition
Nov 6, 2019 —
This petition is designed to prioritize of patient safety by demanding international standardized operating procedures in administration technique methods to reduce likelihood of patient injury (immediate or delayed) by addressing the following:
- Update Electroconvulsive Therapy informed consent paperwork to include all risks outlined in manufacturer user manuals, regulatory updates and instruction guides.
- Establish patient's baseline brain activity and cognitive functioning. Track neurological and neuropsych changes every 6-18 months for the duration of the patients' life as they would for any other procedure with a risk of delayed progressive sequalae.
- Manufacturers must submit Pre-Market Approval Applications based on neuropathology studies and Product Develop Protocols based on PMA to update ECT standards of care and ensure results can be replicated to a larger population, reducing outcome dichotomy. Universal standardized operating procedures for ECT's administration technique which reduce the liklihood of cognitive and neurological damage.
- Provide appropriate comprehensive assessments to identify which ECT recipients experience severe effects acknowledged by manufacturers and the APA, listed as risks. Provide every person with a history of ECT comprehensive assessments to identify appropriate rehabilitative support as necessary, improving quality of life.
- Update Core Competencies of ECT providers (and others working with people who live with mental illness considering or previously exposed to electroconvulsive therapy) to include the neuropathology of repetitive high field-strength electricity to the head, ensuring patients receiving ECT will have appropriate care after treatment.
Update Electroconvulsive Therapy informed consent paperwork to include the following:
- 1:1,000 patients die during ECT treatment. 29% of ECT deaths are Cardiac related. 1:50 ECT patients experience Major Adverse Cardiac Events (MACE). 1:250-500 treatments result in MACE. (MACE is defined as “myocardial infarction, arrhythmia, pulmonary edema, pulmonary embolism, acute heart failure, and cardiac arrest.”) (Duma, A., Maleczek, M., Panjikaran, B., Herkner, H., Karrison, T., & Nagele, P. (2019). Major Adverse Cardiac Events and Mortality Associated with Electroconvulsive Therapy: A Systematic Review and Meta-Analysis. Anesthesiology, 130(1), 83–91. https://doi.org/10.1097/ALN.0000000000002488
- "The whole point of ECT is to trigger a convulsion and there is simply no way around the brain’s threshold: 100 joules of energy, a typical “dose,” ... equals the energy it takes to light up a 100 watt bulb for one second or drop a 73 pound (30kg) weight one foot (33cm) [onto the head]. And it’s the energy that does the damage." -Dr. John Friedberg, Berkeley Neurologist and Yale Scholar
- "Dr. Harold Sackeim published a study in JAMA showing a "relapse rate" of 84% within six months of stopping ECT. According to Berkeley Neurologist and Yale Scholar Dr. John Friedberg, "it is no coincidence that improvement ceases just as the concussive effects are finally waning."
- Information on Riera v Somatics, LLC federal case against manufacturer for permanent brain damage and permanent memory loss.
- Information on delayed low-voltage diffuse electrical injury including the risk of "delayed spinal cord damage and a clinical picture such as a lower motor neuron syndrome, amyotrophic lateral sclerosis, or transverse myelitis – days or decades following the electrical injury."
Information on neuropathology of electrical injury including microhemorrhaging of brain tissue, gliosis, axonal changes, myelin sheath injury, etc.
- Information on delayed electrical injury including historically recognized connection to Amyotrophic lateral sclerosis (ALS), parkinsonism, early-onset dementia, dystonia and dystharia.
- How changes in electrode placement change pathology of electrical injury;
- Remove the word “safe” from all printed literature provided to patients. “Safe” indicates an absence of danger or risk—Neuropathology of exposing the human body to electrical injury is not safe—even when administered by a doctor. Natural laws of electricity do not bend based on intent.
- "Effective" must be removed from printed literature provided to patients, family members and media. Reanalysis by Dr. Irving Kirsch (Associate Director of Harvard's Placebo Studies), Dr. John Read and Dr. Laura McGrath's meta-analyses of all ECT's randomized control trials failed to meet criteria to ensure RTC integrity concluded: "The quality of most SECT–ECT studies is so poor that the meta-analyses were wrong to conclude anything about efficacy, either during or beyond the treatment period. There is no evidence that ECT is effective for its target demographic—older women, or its target diagnostic group—severely depressed people, or for suicidal people, people who have unsuccessfully tried other treatments first, involuntary patients, or children and adolescents. Given the high risk of permanent memory loss and the small mortality risk, this longstanding failure to determine whether or not ECT works means that its use should be immediately suspended until a series of well designed, randomized, placebo- controlled studies have investigated whether there really are any significant benefits against which the proven significant risks can be weighed." (Read, J., Kirsch, I., & McGrath, L. (2019). Electroconvulsive Therapy for Depression: A Review of the Quality of ECT versus Sham ECT Trials and Meta-Analyses. Ethical Human Psychology and Psychiatry, 21(2), 64–103. https://doi.org/10.1891/EHPP-D-19-00014
Prior to ECT, providers will establish patient's cognitive functioning baseline and then track neurological and neuropsychiatric changes yearly for the duration of the patients' life as they would for any other procedure known to cause delayed progressive sequalae.
Establish baseline brain function and cognition to allow doctors, patients and family members to quickly identify possible brain injury and (if necessary) track development of Dementia Pugilistica/Chronic Traumatic Encephalopathy caused by repetitive head injury using the following quantitative assessments. Provide appropriate assessments for repetitive head Injury for every person with a history of ECT to improve quality of life by immediately doing the following assessments:
- Multi-modal QEEG with evoked potential testing to establish baseline brain activity before treatment, during treatment and every 18 months thereafter.
- Videonystagmography (to assess vestibular function, central motor function, CNS injury, retinal impairment, and vertigo.)
- 3T MRI SWI before ECT to identify whether patient has contraindications for treatment (brain bleeds)
- Positron-Emission Tomography (PET) scan (flortaucipir or florbetapir) to identify possible "pattern of tau deposition with minimal amyloid-beta deposition that differs from other disorders" and/or future PET scans developed to identify and track progress of repetitive head injury. PET scan must be provided to patients before and after “index course” of treatment. PET scans must be used to assess for brain injury after 8-12 treatments. PET scans must be repeated every 6 scans after the initial “index course” of treatment and yearly thereafter to track changes.
Functional MRI (fMRI) to track Brain activity and functioning before, during and after treatment. fMRI scans must be used to assess for brain injury after 8-12 treatments. fMRI scans must be repeated every 6 treatments after the initial “index course” and yearly thereafter to track changes.
- S100B protein serum blood testing (before each treatment, after final treatment and yearly thereafter)
- Hyperacusis/Tinnitus hearing assessment
Clinical Test of Sensory Integration and Balance (CTSIB)
Trail Making test
Box and Block Test
Purdue Pegboard Test
Halstead Category Test
Wisconsin Card Sorting Test
Test of Visual Perceptual Skills (non-motor)-Upper Level (TVPS-UL),
Developmental Eye Movement Test (DEM)
Wechsler Adult Intelligence Scale (WAIS),
Delis-Kaplan Executive Functioning System (D-KEFS),
Autobiographical memory Interview (AMI).
Janis Autobiographical assessment
Verbal Learning subtest of the Williams battery
Bender-Gestalt and the Benton Visual Retention Test (with the The Pascal and Suttell method of scoring for deviations on the Bender- Gestalt designs).
- Swallow study every 36 months after ECT
Using neuropathology data from Pre-Market Approval Applications, Manufacturers must develop Product Development Protocols to establish safe limits on ECT administration techniques which minimize cognitive deficits:
- electrode placement
- Pulse type
- Set exact parameters on electrical dosage relative to seizure threshold to the exact seizure threshold (not 1.5 - 6 times seizure threshold discussed in research);
- Treatments must be spaced at least 36.8 days apart to avoid the "cumulative effect" on cognition. (Just like we wouldn't send an athlete back into the field after a direct head hit without complete evaluation and rest before verifying they're not injured);
- Limit the number of treatments to a maximum of 12 treatments in a lifetime (unless PET, fMRI, 3T MRI-SWI indicate patient is not injured after a standard index course (8-12 treatments). Repeat assessments every 12 treatments.
- Use recognized safe-tapering practices to carefully suspend the use of psychotropic medications for at least two weeks prior to ECT;
- Do not use barbiturate anesthetic agents.
- Immediately retire Sine machines and ban further use.
If patients develop symptoms of delayed electrical injury, providing appropriate repetitive head Injury rehabilitation for every person with a history of ECT to improve quality of life.
- Occupational therapy
- Speech therapy
- physical therapy
- Functional Neurology rehabilitation
- Neuro-Optometric Rehabilitation
Updating Core Competencies of neurologists, ECT providers, nurses, social workers, and counselors working with people who live with mental illness considering or previously exposed to electroconvulsive therapy to include the following:
- Neuropathology of ECT using modern clinical parameters.
- Appropriate comprehensive assessments to recognize adverse events listed in ECT device user manuals
- Lab work examining neuropathology slides comparing brains exposed to electricity equivalent dose as administered during an “index course” of ECT with unexposed controls.
- Rehabilitation for persons with repetitive brain injury
- Compensatory strategies for executive functioning deficits, autobiographical memory loss, unemployment and progressive neurological sequalae of motor neuron dysfunction.
- Informed consent updates using all manufacturer recognized risks
- Updated user manual outlining risks associated with permanent brain damage and permanent memory loss.
- Legal case Riera v Somatics, LLC (ECT device manufacturer) & other subsequent cases involving patient injury.
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