Next-Generation Pre-Operative Targeting for Thalamic DBS in the Treatment of Tremor

Essential Tremor Clinical Trial

Official title:

Transform the Practice: Next-Generation Pre-Operative Targeting for Thalamic DBS in the Treatment of Tremor

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03875404
• Other study ID #: 18-010340
• Status: Completed
• Phase: N/A
• Start date: March 20, 2019
• Est. completion date: February 12, 2021

Study information

• Verified date: September 2021
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Researchers are investigating improved methods of targeting deep brain stimulators for treatment of essential tremor relying on brain connectivity measures derived from MRI.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: February 12, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of refractory essential tremor scheduled for unilateral thalamic deep brain stimulator placement

• Age = 18 years

Exclusion Criteria:

• Prior deep brain stimulator, stereotactic radiosurgery, or focused ultrasound procedure for treatment of tremor

• Presence of concomitant movement disorder (e.g. Parkinson's disease, dystonia, etc.)

• Known pre-existing structural brain abnormality (e.g, infarction, tumor, prior brain surgery, etc.)

• Contraindication to 3 Tesla brain MRI (e.g. incompatible implanted device)

• Pregnant

Related Conditions & MeSH terms

• Essential Tremor
• Tremor

Intervention

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.

Locations

Country	Name	City	State
United States	Mayo Clinic in Florida	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in tremor rating score	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.	One year

External Links

•   Mayo Clinic Clinical Trials