Next-Generation Pre-Operative Targeting for Thalamic DBS in the Treatment of Tremor
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03875404|
Recruitment Status : Completed
First Posted : March 14, 2019
Last Update Posted : March 11, 2021
|Condition or disease||Intervention/treatment||Phase|
|Essential Tremor||Diagnostic Test: Functional MRI||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Transform the Practice: Next-Generation Pre-Operative Targeting for Thalamic DBS in the Treatment of Tremor|
|Actual Study Start Date :||March 20, 2019|
|Actual Primary Completion Date :||December 31, 2020|
|Actual Study Completion Date :||February 12, 2021|
|Experimental: Deep Brain Stimulation subjects||
Diagnostic Test: Functional MRI
A special type of MRI measuring the metabolic changes that occur within the brain. It may be used to examine the brain's anatomy and determine which parts of the brain are handling critical functions. It helps identify important language and movement control areas in the brain.
- Change in tremor rating score [ Time Frame: One year ]
Fahn, Tolosa, Marin Tremor Rating Scale 1-9 Tremor (rate tremor)
0 = None
- = Slight.
- = Moderate amplitude.
- = Marked amplitude
- = Severe amplitude
0 = Normal
- = Mildly abnormal.
- = Moderately abnormal.
- = Marked abnormal.
- = Severely abnormal.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03875404
|United States, Florida|
|Mayo Clinic in Florida|
|Jacksonville, Florida, United States, 32224|
|Principal Investigator:||Erik H Middlebrooks||Mayo Clinic|