Directional Versus Nondirectional DBS for ET
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Essential Tremor
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Crossover AssignmentIntervention Model Description: Double-blinded crossover designMasking: Triple (Participant, Investigator, Outcomes Assessor)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 80 years
- Gender
- Both males and females
Description
Specific Aims: To compare the therapeutic window (TW) of directional versus nondirectional deep brain stimulation for treatment of tremor. Hypothesis: directional DBS will result in a wider TW than nondirectional DBS. To compare the effects of directional versus nondirectional DBS on speech Hypothes...
Specific Aims: To compare the therapeutic window (TW) of directional versus nondirectional deep brain stimulation for treatment of tremor. Hypothesis: directional DBS will result in a wider TW than nondirectional DBS. To compare the effects of directional versus nondirectional DBS on speech Hypothesis: Objective and subjective speech impairment will occur to a greater extent in nondirectional DBS versus directional DBS optimized for tremor control. To compare the effects of directional versus nondirectional DBS on balance and gait Hypothesis: Objective and subjective balance and gait impairment will occur to a greater extent in nondirectional DBS versus directional DBS optimized for tremor control. To assess efficacy for tremor of nondirectional and directional DBS in an optimized programming configuration Hypothesis: both directional and nondirectional DBS will significantly improve tremor compared to baseline.
Tracking Information
- NCT #
- NCT04828798
- Collaborators
- Not Provided
- Investigators
- Not Provided
Get Well Soon