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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03875404
Enrollment
9
Registered
2019-03-14
Start date
2019-03-20
Completion date
2021-02-12
Last updated
2021-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Essential Tremor

Keywords

Deep Brain Stimulation

Brief summary

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

Interventions

DIAGNOSTIC_TESTFunctional 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.

Sponsors

Mayo Clinic
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in tremor rating scoreOne yearFahn, Tolosa, Marin Tremor Rating Scale 1-9 Tremor (rate tremor) 0 = None 1. = Slight. 2. = Moderate amplitude. 3. = Marked amplitude 4. = Severe amplitude 0 = Normal 1. = Mildly abnormal. 2. = Moderately abnormal. 3. = Marked abnormal. 4. = Severely abnormal.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026