Research Studies
Posted on April 12, 2021

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Apr. 12, 2021– Sage Therapeutics, Inc. (Nasdaq: SAGE) and Biogen Inc. (Nasdaq: BIIB) today reported topline results from the Phase 2 KINETIC Study evaluating SAGE-324 in the treatment of people with essential tremor (ET).

Research Studies

The University of Texas Health Science Center at Houston is recruiting patients for a study to help boost the understanding of deep brain stimulation (DBS) for essential tremor. Led by Dr. Albert Fenoy, associate professor of neurosurgery at McGovern Medical School at UTHealth, the study is being funded by a $2.1 million grant from the National Institutes of Health (NIH).

With DBS, electrical stimulation is delivered to the brain through an electrode implanted deep into the VIM nucleus of the thalamus. The implanted electrode is connected to a neurostimulator which provides the appropriate amount of electrical stimulation to control tremor. However, over time its effectiveness can decrease due to ET progression. So the volume can be adjusted to compensate but can lead to side effects such as worsening of balance, or ataxia in up to 20 percent of patients. This study will seek to discover if the stimulation is modulating something in the cerebellum which is causing this.

A total of 72 patients are being recruited for the study. Each will undergo DBS for essential tremor and will be followed for two years.

Eligibility criteria includes:

Age:  18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:  All

Inclusion Criteria:

  • the diagnosis of essential tremor, made by a movement disorder neurologist, where tremor is not secondary to any disease process or traumatic insult
  • distal appendicular tremor, with minimal proximal component
  • tremor refractory to multiple medication regimens and/or where the medications cause intolerable side effects
  • tremor judged to be severely impacting their quality of life.

Exclusion Criteria:

  • significant neurological disorder
  • significant dementia or neurocognitive limitations as assessed by neuropsychiatry (when necessary)
  • severe psychiatric illness with suicidal ideations
  • previous surgery to destroy the target region of the brain
  • surgical contraindications to DBS
  • current major medical problems that affect brain anatomy,neurochemistry, or function, e.g., liver insufficiency, kidney insufficiency, cardiovascular problems, systemic infections, cancer, hypothyroidism, auto-immune diseases, and any current of history of brain disorder (seizure disorder, stroke, dementia, meningitis, encephalitis, degenerative neurologic diseases and head injury with loss of consciousness for any period of time)
  • family history of hereditary neurologic disorder, besides essential tremors ET
  • floating metallic objects in the body
  • pregnancy
  • alcohol or substance abuse/dependence in the past 6 months.

To learn more or to see if you qualify to take part in the study, email albert.j.fenoy@uth.tmc.edu or susan.m.pouliot@uth.tmc.edu, or call (713) 486-7780 or (713) 486-8000. Learn more on the clinicaltrials.gov website here.

Research Studies

The purpose of this study is to see if the MR-guided focused ultrasound (MRgFUS) thalamotomy procedure can be performed on both sides of the brain safely and effectively to reduce bilateral tremor.

Ages Eligible for Study:  22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:  All
Accepts Healthy Volunteers:  No

Criteria

Inclusion Criteria:

  1. Men and women age 22 years or older
  2. Diagnosis of medication-refractory Essential Tremor
  3. Has previously underwent an Exablate index procedure in a clinical trial or in a commercial setting at least 9 months prior to enrolling in this trial
  4. Able to communicate sensations during the Exablate thalamotomy procedure

Exclusion Criteria:

  1. Has experienced any non-transient neurological event or worsening following the Exablate index procedure
  2. Presence of unknown or MR unsafe devices anywhere in the body
  3. Non-transient hemiparesis as determined by physical examination
  4. Clinically significant abnormal speech function as determined by a speech pathologist
  5. Pregnant or breastfeeding
  6. Unstable cardiac status
  7. Behavior(s) consistent with ethanol or substance abuse
  8. History of bleeding disorder
  9. Has received anticoagulants within one month of Exablate procedure
  10. Cerebrovascular disease
  11. Intracranial tumor
  12. Active or suspected acute or chronic uncontrolled infection
  13. Has previously had deep brain stimulation or a prior stereotactic ablation of the basal ganglia or thalamus
  14. Implanted objects in the skull or the brain
  15. Currently in a clinical trial involving an investigational product or non-approved use of a drug or device or in any other type of medical research
  16. Unable to communicate with the investigator and staff

Locations:

University of Maryland, Baltimore
Contact: Charlene Aldrich, 410-328-5332, cladrich@som.umaryland.edu   

Weill Cornell Medicine, New York, NY
Contact: Marissa Michael, 212-746-7373, mam4001@med.cornell.edu OR
Contact: Sophie O’Bryan, 212-746-1788, soo4001@med.cornell.edu.

University of Pennsylvania, Philadelphia
Contact: Keren Somers, 215-829-6720, keren.somers@pennmedicine.upenn.edu OR
Marie Kerr, 215-829-6720, kerrm@uphs.upenn.edu

University of Virginia, Charlottesville
Contact: Matthew Patterson, 434-243-7336, mwp5f@virginia.edu

Also, watch for clinical trial sites opening at The Ohio State University and Stanford.

To see more information on this clinical trial, click here.

Research Studies
Posted on August 3, 2020

Queensland Brain Institute at The University of Queensland, Australia, offers the public the opportunity to become involved in research through volunteering for clinical trials. Several are ongoing and are listed on their website.

Research Studies
Posted on July 14, 2020

Dr. Elan Louis and his colleagues at UT Southwestern Medical Center are conducting a groundbreaking, national research initiative in the study of essential tremor.

This research is being conducted in an entirely REMOTE and VIRTUAL format, which ensures the health and safety of our study subjects while also maintaining pioneering research operations. Study activities can be completed using ONLINE platforms such as Zoom or Skype, or simply by telephone. You will have the opportunity to contribute to meaningful ET research from the comfort and safety of your own home.

The study of cognition in essential tremor (COGNET) is the first of its kind to track cognitive changes of an exclusive cohort of individuals with ET. We are excited to announce that COGNET has received funding to extend its innovative work. So far, 230 individuals have participated in this unique longitudinal study; we are now calling on the ET community to help us expand our selective cohort to 295 individuals. We hope that you will help us complete this pioneering, NIH-funded research in essential tremor!

Interested candidates must meet the following criteria:

  1. You have been diagnosed by a doctor as having ET (rather than dystonia or Parkinson’s Disease, for example).
  2. You are at least 80 years old.
  3. You did NOT have brain surgery for the treatment of ET (e.g. DBS, FUS).
  4. *You are willing to have three interviews with us at your home (now, 18 months, 36 months).  Each interview will consist of questions about your tremor, various questionnaires and puzzles, and a videotaped neurological exam. The first interview will also include a blood draw (1 tube). Researchers will travel to meet with qualified participants; visits will take place over two days, with a 2.5-hour interview scheduled for each day. 
  5. You are willing to become a brain donor in the future. We would discuss this further with you.

If you are interested, please send an email to: cognet@utsouthwestern.edu or call 214-648-9888, 214-648-3431, or 203-554-7854.

*Virtual interviews are being conducted during COVID-19.

Research Studies
Posted on July 14, 2020

Dr. Elan Louis, chair of the Department of Neurology and Neurotherapeutics and his colleagues at UT Southwestern Medical Center are conducting a groundbreaking, local research initiative in the study of essential tremor. Risk factors underlying essential tremor (RULET) is a research study that tracks the environmental causes associated with movement disorders such as Essential Tremor (ET) and Parkinson’s disease (PD). This NIH funded study is excited to begin recruitment in the Dallas-Fort Worth area. We hope that you will help us complete this unique research.

Interested candidate should meet the following criteria:

  1. You are at least 50 years old.
  2. You live near UTSW (maximum of 3hrs away by car)
  3. You have been diagnosed with Essential Tremor
  4. You do not have a medical history of Parkinson’s disease (PD) or Dystonia

If you decide to enroll, you will take part in a phone screening and an in-person interview that lasts approximately three hours. A research assistant will travel to your home at no cost to you. The interview includes a blood draw, a neurological videotaped evaluation and the completion of several questionnaires.  You will be compensated for your time ($40)

If you are interested or have any questions, please call 214-648-9884, 214-648-3485, 214-645-6239 or e-mail us at: rulet@utsouthwestern.edu

Research Studies
Posted on July 14, 2020

Dr. Elan Louis, chair of the Department of Neurology and Neurotherapeutics, and his colleagues at UT Southwestern Medical Center are conducting a groundbreaking, local research initiative in the study of essential tremor. Risk factors underlying essential tremor (RULET) is a research study that tracks the environmental causes associated with movement disorders such as Essential Tremor (ET) and Parkinson’s disease (PD). This NIH funded study is excited to begin recruitment in the Dallas-Fort Worth area. We hope that you will help us complete this unique research.

Interested candidate should meet the following criteria:

  1. You are at least 50 years old.
  2. You live near UTSW (maximum of 3hrs away by car)
  3. You have been diagnosed with Essential Tremor
  4. You have a medical history Parkinson’s disease (PD)

If you decide to enroll, you will take part in a phone screening and an in-person interview that lasts approximately three hours. A research assistant will travel to your home at no cost to you. The interview includes a blood draw, a neurological videotaped evaluation and the completion of several questionnaires.  You will be compensated for your time (40$)

If you are interested or have any questions, please call 214-648-9884, 214-648-3485, 214-645-6239 or e-mail us at: rulet@utsouthwestern.edu

Research Studies

Yale University – New Haven, Connecticut

What causes essential tremor is currently a question with no known answer. Brain donations (also called postmortem examination or autopsy) are the only way to find the answers to this question. With these answers, better treatments can be developed and a cure can be found.

Medical researchers at Yale University, with the help of the IETF, maintain a centralized brain bank to serve the ET community. This will enable doctors to begin to actively study what happens in the brains of people with ET. Unfortunately, there is a severe shortage of brain tissue donations from people who had ET during life.

Eligible donors will have been diagnosed with essential tremor by a physician, they would not have any other neurological diagnoses (eg. Dystonia, torticollis, Parkinson’s disease), would be ages 70 and older, and had not had Deep Brain Stimulation surgery or any other surgical intervention to treat their tremor.

If you are interested in helping find the causes of ET and want to leave a medical legacy for future generations, please call 203.785.5301 or email tremor@yale.edu, and you will be sent an information packet on brain donation. Or for more information, visit www.essentialtremor.us.

Brain Donor Project

The Brain Donor Project is a non-profit that supports the brain banks of the National Institutes of Health (NIH), the NeuroBioBank, to increase the supply of donated brain tissue for scientific research. There is no cost to the family to donate a brain to a NeuroBioBank site, nor to receive a copy of the donor’s neuropathology report if requested. No age restrictions and very few limitations on eligibility are in place, but it is highly recommended to register in advance. Learn more.

The Brain Observatory – San Diego, California

The Brain Observatory’s brain bank in San Diego, California is now accepting brain donations from patients who have been diagnosed with Essential Tremor (ET). The effort is part of the institute’s Digital Brain Library project, a web-accessible digital archive of neurological data that will be open to worldwide collaboration. Potential brain donors may also participate in active ET research. By combining modern neuroimaging techniques and detailed behavioral testing with the eventual examination of the brain, researchers aim at obtaining a new and more comprehensive picture of ET.

Note: The program is currently enrolling only residents of San Diego county; however, potential participants from other areas will be signed into a registry that may be the basis for future larger studies.

Please contact Mrs. Ruth Klaming for more information about brain donation or research participation. For more details on the Digital Brain Library, visit their website.

Research Studies

Mount Sinai School of Medicine is conducting an essential tremor research trail. This study is only open to those living in the New York City area. This research trial will study persons who:

  • have essential tremor
  • have troublesome hand tremor
  • have tremor in both hands
  • do not have liver insufficiency

The purpose of this research study is to find out whether perampanel, a medication marketed for the treatment of seizures, reduces hand tremor in persons with essential tremor. Participants will have tremor observed and video-taped and answer questionnaires so that investigators can find out whether perampanel reduces tremor. During the study, perampanel is taken for 14 weeks, and a placebo for 14 weeks. Total participation will last up to 40 weeks. There are a total of 6 visits, and participants will be compensated for each visit.

To learn more about “A Double-Blind, Cross-Over, Placebo-Controlled Efficacy and Tolerability Study of Perampanel for Essential Tremor” contact the Principal Investigator:

Mindy Lopez
The Robert and John M. Benheim Parkinson’s and Movement Disorders Center
New York, NY
212-241-9038
mindy.lopez1@mssm.edu

Winona Tse, MD
Department of Neurology
Icahn School of Medicine at Mount Sinai
5 East 98th St., New York
212-241-5607
winona.tse@mssm.edu

Joan Bratton
212-241-0279 or joan.bratton@mssm.edu

Research Studies

The essential tremor research team at Columbia University, headed by Dr. Sheng-Han Kuo, is looking for people in the New York City area with essential tremor, to study their brain activity using an electroencephalogram (EEG).

EEG is a routine clinical procedure to study brain activity and could be used to study essential tremor. One of the most important questions for essential tremor is: from which region of the brain does the tremor originate? To try and answer this question, researchers will place EEG leads on the scalp of study participants, to study their brain activity. Researchers will study activity across the whole brain with the hope of identifying the source of the abnormal brain activity that causes tremor. This study aims to help researchers better understand the area of the brain responsible for essential tremor, which will, in turn, help researchers find more effective ways to treat it.

Study Details

  • EEG is a non-invasive procedure.
  • You will need to travel to Columbia University Medical Center for this study, but reimbursement will be provided for travel expenses.
  • The study will last for approximately 2 hours.
  • There is no blood draw involved.

Inclusion Criteria
In this study, researchers are looking for people who have had a diagnosis of essential tremor for more than 3 years.

Contact Information
If you are interested in this study or have questions, please contact Dr. Shi-Bing Wong or call 212-342-3753.