Patent Application
20070282388
Reference will now be made to the drawings in which similar elements in different drawings bear the same reference numerals.
The present invention is an effective method of treatment for improving or ameliorating the symptoms of patients suffering from ALS. The method seeks to trigger the pineal gland via picotesla-flux-density AC-pulsed electromagnetic fields (EMFs) induced from an array of coils placed on the skull of the patient. The treatment method of the instant invention utilizes transcranial AC-pulsed applications of EMFs in substantially square waveforms constructed from multiple sinusoidal waves at different frequencies in the picotesla flux density, applied to the patient's brain via a transducer array containing a plurality of spiral coils, to successfully ameliorate (if not eliminate specific symptoms) the symptoms of ALS and slow the progression of the disease. It is theorized herein that the pineal gland is pivotal in the pathogenesis of ALS, and that EMF treatment, via transduction through the cranium aimed by a flexible coiled array at the pineal gland, affects 5-HT neurotransmission when picotesla levels at specific, signature waveforms, amplitudes, frequencies, and duty cycles are applied to ameliorate neurological conditions. In particular, the subject invention relates to, but is far and away an improvement over, the studies performed by the subject inventor, including those disclosed and claimed in his other patents including, without limitation, U.S. Pat. Nos. 5,470,846; 5,691,324; 5,691,325; 5,885,976, the contents of which are incorporated by reference herein.
The invention is a method whereby an ALS patient is pulsed with EMFs at picotesla flux density levels. Such EMFs are applied via a transcranial, flexible, skull plate having a plurality of serially connected circular coils in a transducer array. The method involves AC-pulsed application in substantially square waveforms at a frequency range which corresponds to the lower range of theta activity recorded from the skull on the electroencephalogram (EEG) applied to the patient's brain. The effect of the treatment is to ameliorate symptoms of ALS and thereby slow (if not cease) the progression of the disease.
Patients treated with AC pulsed EMFs have experienced dramatic improvements in, inter alia, fatigue, endurance, mood, appetite with weight gain, and sleep (with recurrence of dreams) as well as increased muscle strength and muscle bulk in the limbs resulting in improvement in mobility, manual dexterity, trunk and shoulder control, chewing, swallowing, and breathing. There were also improvements in autonomic functions including bladder and bowel control, sweating, blood pressure and heart rate, and skin temperature. In addition, this treatment appeared to slow the progression of the disease and in the majority of patients the course of the disease was stabilized and these patients showed continued improvement over several months of observation.
In accordance with a preferred treatment protocol, the substantially square waveform is symmetric, has a duty cycle of approximately 50%, and has a frequency of approximately 3.45 Hertz. Preferably the alternating current has an amplitude of 1.2 microamperes.
The substantially square waveforms produced by the waveform generator 2 are constructed from multiple sinusoidal waves at different frequencies. The waveform generator 2 comprises a current generator and an output resistor, by which the current generator is coupled to the coils. The waveform generator 2 also includes controls for selecting the frequency and duty cycle of the alternating current, the waveform of the current, and the amplitude of the current.
Referring to
The medical administrator performs a method for treating an ALS patient comprising the following steps: (a) placing the coil array in proximity to the head of a patient that has been diagnosed with ALS; and (b) activating the coil array to transmit electromagnetic radiation having a flux density of 100 picotesla or less into the brain of the patient, wherein the activating step comprises the step of supplying an alternating current with a substantially square waveform having a duty cycle of 40 to 60%, a rise time and a fall time of less than 20 microseconds, a frequency in a range of 2 to 5 Hertz. The alternating current has an amplitude in the range of 0.5 to 1.5 microamperes.
During application of AC-pulsed EMFs having a flux density in the range of 10 to 100 picotesla, patients experienced regularly intermittent sensations of itching, tingling, twitching, and sneezing and also a sense of pulsations in the affected muscle groups coupled with frequent episodes of yawning and stretching. In contrast to other neurological disorders treated with AC-pulsed EMFs (e.g. multiple sclerosis, Parkinson's disease, Alzheimer's disease), treatment using the instant method does not result in a decline in function between the treatment sessions and sensory phenomena such as itching, tingling, twitching, and sense of pulsations in various muscle groups continuing for hours and even days after the termination of EMF treatment. Also in contrast to other neurological disorders treated with AC-pulsed EMFs, treatment using the instant method, ALS patients responded to a specific EMF signal characteristic, irrespective of the presenting clinical symptoms, course of the disease, or duration of the disease.
The signal characteristics include the waveform, rise and fall times of the square wave, amplitude, frequency, and duty cycle of the EMF radiation. Even a small deviation from the patient's signal characteristics utilized in the instant treatment method can result in a lack of response or potentially rapid worsening of symptoms (e.g., weakness of the legs and hands, difficulties swallowing and breathing, etc.). The substantially square wave used in the instant treatment method is believed to be the critical and fundamental waveform for the treatment of ALS. A substantially square wave is mathematically equivalent to the sum of a sinusoidal wave at that same frequency, plus an infinite series of odd-multiple frequency sinusoidal waves at diminishing amplitudes. The substantially square wave has large harmonics at odd multiples of the fundamental frequency (e.g., odd integer harmonics). An ideal square wave is composed of an infinite number of odd harmonics. Before filtering, the sinusoidal waves are in phase. The effects of a substantially square wave on the symptoms and course of ALS are suspected to be related to a sum of multiple sinusoidal waves of various frequencies and phases interacting with the pineal gland and possibly also directly with cortical motoneurons. The duty cycle of the simulating signal ranges from 40% to 60%. The rise and fall times are equal in duration (<20 microseconds). The optimal frequency of the signal is 3.45 Hertz with a period of 0.29 second, which corresponds to the low theta (electroencephalogram) EEG activity (3-7 Hertz) recorded from the human skull with surface electrodes. The optimal amplitude (0.5 to 1.5 microamperes) of the current signal produces a magnetic field flux density of 10 to 100 picotesla, which is within the range of the magnetic field generated by neural activity in the human brain.
A 48-year-old left-handed male computer programmer developed weakness of the right hand in 2000 with difficulty holding objects and frequently dropping objects with his right hand. In 2001, he noticed his right hand was clumsy while manipulating a computer mouse. At the end of 2001, he developed difficulty writing with his left hand. In January of 2002, electromyography (EMG) was performed and showed acute and chronic denervations in the upper extremities, including cervical, thoracic and lumbar paraspinal muscles. In March 2002, he was diagnosed with amyotrophic lateral sclerosis (ALS) at Columbia-Presbyterian Medical Center.
In April 2002, he developed muscle cramps in his hands at rest as well as on exertion. EMG performed in May 2002, involving evaluation of selected muscles in the right leg and both upper extremities, revealed fibrillations and fasciculations, polyphasic, large-amplitude motor units and reduced recruitment on maximal effort. EMG examination of the tongue revealed fibrillations and full recruitment, indicating progression of the disease.
Over the following 3 years the patient developed increasing weakness of his arms, hands and fingers. Simultaneously, he also experienced progressive weakness of the legs resulting in bilateral foot drop. There was also weakness of the trunk musculature and he had difficulties sitting upright. He became wheelchair dependent in 2003 and required foot drop braces. He denied difficulties with speech or swallowing. About one year ago he experienced occasional shortness of breath with stress. He fatigued easily and yawned frequently during the day. He reported to sleep about 10 hours per night and recalled frequent dreaming (none in color). The fatigue was not relieved by sleep and was particularly severe in the morning until about 1 p.m. He was treated with modafinil for the past year with little improvement in fatigue. He denied cognitive difficulties but he experienced some slowing of thought processes. He weighed 165 pounds as compared to 190 pounds 3 years ago. His appetite was fair and he experienced daily episodes of nausea in the morning. He also experienced heat intolerance. He had increased daytime urinary frequency, voiding almost hourly with nocturia X1. He carried a urinal with him when traveling outside his home. He denied pain or visual problems. He had intermittent cramping in the legs. He denied experiencing spontaneous itching, tingling or pulsations in the extremities. His medications included riluzole 50 mg twice daily, modafinil 100 mg daily, and sertraline 50 mg daily.
On examination on Aug. 16, 2005 his blood pressure was 110/70 mmg, pulse was 78/min and regular, and p02 was 93% on pulse oximetry. He was alert and fully oriented without speech impairment. There was no pseudobulbar affect but he appeared depressed. Examination of the cranial nerves was unremarkable. Motor examination revealed profound weakness in both upper and lower limbs (upper extremities: biceps 2+/5 left, 2/5 right; triceps 2+/5 left, 2/5 right; wrist extension 2+/5 left, 2/5 right; finger abduction 1+/5 left, 1/5 right; lower extremities: hip flexion 2+/5 left, 1+/5 right; knee extension 3+/5 left, 2+/5 right; hip adduction 2+/5 left, 1+/5 right; foot inversion 2+/5 left, 1+/5 right). There was flexion of the middle digits of both hands. He was unable to hold objects in his hands or grasp small objects with his fingers due to limited range of movement of the thumbs and forefingers. There was marked atrophy of the muscles of the upper arms and shoulders (particularly the deltoids), forearms, and intrinsic hand muscles. There was moderate atrophy of the back musculature. There were diffuse fasciculations in the upper limbs, chest, back musculature, and lower limbs. Biceps and triceps tendon reflexes were 1+ bilaterally. Hoffmann's sign was negative bilaterally. Knee jerks and ankle reflexes were 2+ bilaterally. Plantar responses were flexor bilaterally. Muscle tone was increased in the legs, greater on the right. He wore braces on both ankles. He was unable to elevate his legs to walk. He had a broad-based waddling gait. He fatigued after walking about 10 feet and promptly requested to sit back in the wheelchair. There was no sensory loss or cerebellar signs.
Pulsed electromagnetic fields (EMFs) were administered transcranially over the patient's scalp for 9 months at a rate of 3 treatments per week. Each treatment was administered for 2 hours, usually between 1 and 3 p.m. The EMFs were applied via a transducer coil array in a dark room that was magnetically unshielded.
The frequency of the AC-pulsed EMF was 3.45 Hertz for 6 months and 4.75 Hertz for the past 3 months. The amplitude of the current supplied to the coil array was 1.20 microamperes. The waveform was square (rectangular) with a duty cycle of 50% and rise and fall times of less than 20 microseconds.
Within the first hour, the patient developed recurrent episodes of yawning (12 times during 60 minutes). There were itching sensations in the face (left side), forehead and nose. There was increased strength in the lower limbs (able to raise both legs higher, particularly left leg) and trunk (sitting more erect). There was increased range of finger movements including the thumbs. Fingers felt less stiff and he was able to open and close his hands with greater ease. Mentally, patient felt a surge in energy and mood elevation. During the second hour he continued to yawn frequently (13 times during 60 minutes). The itching sensations in the face, forehead and nose were more intense. He felt tingling sensations in the fingertips. Towards the end of treatment, he felt hungry and craved for sweets.
Two days later, the patient returned for treatment. He reported experiencing a constant urge to yawn. In addition, he experienced increased sweating and markedly reduced need to urinate (from hourly prior to treatment to now every 2-3 hours). Also, for two prior days he woke up 2 hours earlier in the morning and reported feeling more energetic. Functionally, he was able to rise from the chair without assistance. His legs and trunk felt stronger. Blood pressure was 110/70 mm Hg, pulse 85/min and p02 was 97% on pulse oximetry. His mood was optimistic and he was smiling. He walked a longer distance (20 feet) unassisted at a faster pace. Finger abduction was 2+/5 on the left and 2/5 on the right. Hip flexion was 3+/5 on the left and 2+/5 on the right.
He subsequently received his second electromagnetic treatment of 2 hours duration, during which time he yawned 45 times (deep and prolonged yawns). Yawning was often associated with stretching of the trunk and arms. During treatment, the patient experienced itching sensations in the face, eyes, forehead and nose, tingling sensations in the fingertips and thumbs, twitching sensations in the back and shoulders, and pulsations in the arms and legs. He felt warm and his nose felt slightly congested. The patient sneezed twice successively. These sensations did not occur spontaneously prior to initiation of electromagnetic treatment. Mentally, he felt more alert and noted increased strength in the lower limbs (he was able to raise both legs significantly higher, particularly his left leg). His left shoulder became more mobile and his abdominal musculature felt tighter.
During 9 months of electromagnetic treatment, the patient experienced a host of radical changes in his disease. He experienced a sense of well being, which, according to the patient, “I have not felt in many months.” His level of energy increased dramatically throughout the course of the day. He had no fatigue. He slept well throughout the night and recalled dreaming, frequently in color. He woke up spontaneously at about 7:30 a.m. without fatigue. The nausea and dizziness sensations abated. He experienced improved heat tolerance and was able to sit in the sun without experiencing nausea. Frequency of urination declined dramatically and he voided 3 times daily. He abandoned the use of a urinal. Appetite improved and he gained about 12 pounds in 9 months. He experienced a sense of mental clarity and his wife reported that he became more assertive in conversations. On several occasions he slept on his left side without experiencing any shoulder pain in the morning.
He became more functional in daily activities. He frequently arose from bed unassisted. He felt more stable on his feet. He stood significantly longer before experiencing weakness in his knees and legs. During meals, he brought food up to his mouth with his left arm instead of leaning down to reach for food. There was improvement in pincer movements of the left hand and increased control and range of movement of the thumbs. He was able to brush his hair with the left hand and dial the telephone due to improved hand strength. He crossed his legs with no effort. On one occasion he recalled visiting a book store and walking around for about 45 minutes, pushing his wheelchair in front of him. Unassisted, he walked about 50 feet before needing to rest.
On Apr. 16, 2006, the patient stated that he now functioned at the level of at least one year ago. Motor examination revealed increases in both upper and lower limbs (upper extremities: biceps 3/5 left, 2+/5 right; triceps 3/5 left, 2+/5 right; wrist extension 3/5 left, 2+/5 right; finger abduction 2+/5 left, 2/5 right; lower extremities: hip flexion 3+/5 left, 2+/5 right; knee extension 3+/5 left, 3/5 right; hip adduction 3+/5 left, 2+/5 right; foot inversion 3+/5 left, 2+/5 right).
While the invention has been described with reference to particular embodiments, it will be understood by those skilled in the art that various changes may be made and equivalents may be substituted for members thereof without departing from the scope of the invention. In addition, many modifications may be made to adapt a particular situation to the teachings of the invention without departing from the essential scope thereof. Therefore it is intended that the invention not be limited to the particular embodiment disclosed as the best mode contemplated for carrying out this invention, but that the invention will include all embodiments falling within the scope of the appended claims.
