Current Clinical Trials

Assessment of Safety & Efficacy of Treatment of Essential Tremor by Noninvasive Nerve Stimulation Using Allevx™ Device
  1. John Legge, MD
    John Legge, MD
  2. for people 22 to None (full criteria)
  3. Rancho Mirage, CA
  4. study started October 2023
  5. John Legge, MD
  6. Accepting new patients

Description

Summary

The primary objective of this single-center, double-blind, and sham-controlled, study is to assess the safety & efficacy of the Allevx™ device (Allevion Therapeutics, Irvine, CA) for temporary relief of essential tremor.

Official Title

Assessment of Safety & Efficacy of Treatment of Essential Tremor by Noninvasive Nerve Stimulation Using the Allevx™ Device

Detailed Description

Inclusion criteria 1. Essential tremor or Essential Tremor plus (includes soft signs such as impaired memory, tandem gait, subtle body dystonic posturing) diagnosis according to MDS consensus criteria 2. Men and women ≥ 22 years old 3. TETRAS score dominant hand ≥ 2 4. Stable dose of tremor medication for 30 days prior to baseline 5. Stable dose of anti-depressant medication for 30 days prior to baseline 6. No tremor medication for 6 hours prior to stimulation session 7. Significant... more
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Inclusion criteria
1. Essential tremor or Essential Tremor plus (includes soft signs such as impaired memory, tandem gait, subtle body dystonic posturing) diagnosis according to MDS consensus criteria
2. Men and women ≥ 22 years old
3. TETRAS score dominant hand ≥ 2
4. Stable dose of tremor medication for 30 days prior to baseline
5. Stable dose of anti-depressant medication for 30 days prior to baseline
6. No tremor medication for 6 hours prior to stimulation session
7. Significant disability due to tremor (Bain & Findley score of ≥ 3 on any hand item)
Exclusion criteria
1. Moderate to severe alcohol dependence (DSM-V score > 4)
2. Implanted active electrical medical device of any kind
3. Previous ablative CNS surgery (e.g., thalamotomy)
4. Skin lesions at stimulation site that might interfere with electrodes or be significantly exacerbated by treatment
5. Clinically significant peripheral neuropathy (stage 3 or higher)
6. Tremor due to other etiologies, including neurodegenerative disease
7. Botulinum toxin injection for hand tremor within 6 months prior to baseline
8. Unable to understand or provide written consent
9. Pregnant and/or breastfeeding women
10. Suspected or diagnosed epilepsy or other seizure disorder
11. Possible causes of tremor other than essential tremor
12. Neurological examination inconsistent with essential tremor

Keywords

Essential Tremor (ET)

Eligibility

for people 22 to None
The study will include up to 50 men and women aged 22 and older with a diagnosis of essential tremor involving the hands confirmed by movement disorders neurologists. ... more
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The study will include up to 50 men and women aged 22 and older with a diagnosis of essential tremor involving the hands confirmed by movement disorders neurologists.

Lead Scientist at Eisenhower Health

John Legge, MD
John Legge, MD is a board-certified Neurologist with fellowship-training in Movement Disorders. He is located in Palm Springs at the Eisenhower Health Center at South Palm Canyon.After attending medical school at The University of Tennessee Health Science Center in Memphis, Tennessee, Dr. Legge served as Chief Resident at VCU in Richmond, Virginia. He is a graduate of the Palatucci Leaderhip Forum, which is a physicians’ grassroots advocacy training program hosted by the American Academy o... more
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John Legge, MD is a board-certified Neurologist with fellowship-training in Movement Disorders. He is located in Palm Springs at the Eisenhower Health Center at South Palm Canyon.

After attending medical school at The University of Tennessee Health Science Center in Memphis, Tennessee, Dr. Legge served as Chief Resident at VCU in Richmond, Virginia. He is a graduate of the Palatucci Leaderhip Forum, which is a physicians’ grassroots advocacy training program hosted by the American Academy of Neurology. He  completed a subspecialty fellowship program in Movement Disorders at the University of California San Diego.

Dr. Legge was always interested in sciences and was influenced to attend medical school watching his family care for his grandmother who was afflicted with dementia. Her geriatrician had a large influence on his decision to become a physician. “I was originally going to be a family practice geriatrician,” states Dr. Legge. “But during my neurology rotation in medical school became fascinated with the brain, and I never looked back!”

Dr. Legge emphasizes communication with his patients. “I listen to my patients tell their story. From that I find out what is important to them which provides me the understanding on how best to guide their treatment plan,” reflects Dr. Legge. “We need to be on the same page and develop a strategy together – one that the patient will buy-in to.”

Clinical care is a primary emphasis in Dr. Legge’s work, although he is also involved in quality improvement and clinical education. Outside of work, Dr. Legge enjoys traveling with his husband, visiting wineries and breweries, trying new restaurants and attempting his hand at amateur astronomy. He is an avid dog-lover and is technologically savvy as he enjoys tinkering around with computers and playing video games. He is passionate about providing quality and comprehensive care for the community of movement disorders patients.

Clinical Study Details

  1. Accepting new patients
  2. study started October 2023
  3. March 29, 2024