Functional Brain Network Changes in Patients Undergoing Deep Brain Stimulation for Essential Tremor

Launched by THE CLEVELAND CLINIC · Feb 27, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how deep brain stimulation (DBS) affects brain activity in patients with essential tremor, a condition that causes uncontrollable shaking. The researchers want to understand the changes in brain networks when patients are in different states: when the DBS device is turned on and off, and after trying other methods to reduce tremors, like cooling the limb or taking medication. Participants will sit comfortably in a machine that measures brain activity while they focus or relax, and this will help the researchers learn more about how DBS works in controlling tremors.

To participate in this trial, you need to be between 40 and 80 years old and have a diagnosis of essential tremor for at least three years. You should be able to understand the study and give your consent. People with certain medical conditions, such as other neurological diseases or significant cognitive impairment, won’t be eligible. Throughout the study, participants can expect to engage in simple tasks while their brain activity is monitored, which will help improve the understanding of essential tremor treatment.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Between 30 and 80 years of age;
• • Ability to provide informed consent;
• • Clinical diagnosis of ET by a movement disorders neurologist with a disease duration of at least 3 years and being treated with a DBS; OR
• • Clinical diagnosis of ET by a movement disorders neurologist with a disease duration of at least 3 years and not being treated with a DBS; OR
• • No known neurological disease or disorder.
• Exclusion Criteria:
• • The individual has a condition that, in the opinion of the investigator, would significantly increase the risk for interference with study compliance, safety, or outcome;
• • Presence of active psychiatric symptoms meeting Diagnostic and Statistical Manual of Mental Disorders-4th Edition (DSM-IV) criteria for Axis-I disorder on formal psychiatric evaluation other than depression or anxiety;
• • History of cognitive impairment meeting Diagnostic and Statistical Manual of Mental Disorders-4th Edition (DSM-IV) criteria for dementia on formal neuropsychological evaluation, as documented in chart;
• • Lack of English-language fluency which would interfere with the ability to understand the study consenting process and potential study risks;
• • Hearing or visual impairment precluding testing;
• • Motor impairment impacting test responses (i.e., orthopedic injury or disease);
• • Anyone currently taking medications with Antabuse-like effects (e.g. Flagyl, Bactrim, Tindamax) will be excluded from any alcohol administration.