Essential Tremor
Conditions
Brief summary
Programming Deep Brain Stimulation for the treatment of Essential Tremor can be a time intensive process. Using an atlas created using functional tremor responses in the operating room to determine the optimal settings would lead to a faster response for the patient and improved quality of life.
Interventions
DEVICEChange DBS programming
Patient will change their DBS settings to move from one DBS setting to the other, allowed one hour to adjust to the new setting prior to testing
Sponsors
Vanderbilt University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Seleced for DBS of the VIM nucleus at Vanderbilt Medical center Diagnosis of essential tremor
Exclusion criteria
Unable to use the patient handheld programmer
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fahn-Tolusa-Marsden Tremor Rating Scale | 1 month | Tremor quantification |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| DBS Programming, Standard of Care DBS settings determined from the standard Neurologist symptomatic response, first
Change DBS programming: Patient will change thier settings to move from one group to the other to trial the other DBS settings | 3 |
| DBS Progamming From Atlas DBS settings determined from the a functional atlas only,first
Change DBS programming: Patient will change thier settings to move from one group to the other to trial the other DBS settings | 1 |
| Total | 4 |
Baseline characteristics
| Characteristic | DBS Progamming From Atlas | Total | DBS Programming, Standard of Care |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 4 Participants | 3 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 1 participants | 4 participants | 3 participants |
| Sex: Female, Male Female | 0 Participants | 2 Participants | 2 Participants |
| Sex: Female, Male Male | 1 Participants | 2 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 3 | 0 / 1 |
| other Total, other adverse events | 0 / 3 | 0 / 1 |
| serious Total, serious adverse events | 0 / 3 | 0 / 1 |
Outcome results
Primary
Fahn-Tolusa-Marsden Tremor Rating Scale
Tremor quantification
Time frame: 1 month
Population: Data analysis was not completed because only one participant completed the DBS Programming from Atlas arm and disclosing data could violate privacy interests.