Functional Brain Network Changes in Patients Undergoing Deep Brain Stimulation for Essential Tremor
ConditionEssential Tremor
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age30-80
SponsorThe Cleveland Clinic
About this trial
The purpose of this study is to collect electrophysiological data related to functional brain network changes in patients undergoing deep brain stimulation for the treatment of essential tremor. Participants will either 1) have electroencephalography (EEG) scalp electrodes placed, or 2) remain seated with their head inside of a magnetoencephalography (MEG) recording system, as resting-state and task-related data are acquired. Spontaneous electrophysiological activity will be recorded in both the eyes open and eyes closed conditions with the participant seated comfortably. These recordings will be repeated in the DBS OFF and DBS ON states, with the ON state involving specific settings identified as optimal, sub-optimal, or ineffective at achieving tremor control. They will also be repeated following the optional administration non-DBS tremor mitigation techniques, which may include one or more of the following: 1) cooling the limb, 2) oral administration of alprazolam, 3) oral consumption of ethanol (alcohol), or 4) peripheral nerve stimulation.
Eligibility criteria
Qualifiers
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
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Alcohol
- Alprazolam
- Cold Therapy
- Peripheral Nerve Stimulation
Treatment groups
55 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov