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OpenTrials
Completed

NCT Number: NCT03875404

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

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

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Key information

Conditions

Essential Tremor Central Nervous System Diseases Movement Disorders Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Functional MRI

Diagnostic Test

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.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Mar 14, 2019
Registry last updated
Sep 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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