Not provided
Not provided
Not provided
Not provided
Not provided
Unable to fully enroll no data analysis planned
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DBS programming, standard of care | Active Comparator | DBS settings determined from the standard Neurologist symptomatic response first then change to settings from Atlas |
|
| DBS progamming from Atlas | Experimental | DBS settings determined from the a functional atlas first then change to settings determined by standard of care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Change DBS programming | Device | 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fahn-Tolusa-Marsden Tremor Rating Scale | Tremor quantification | 1 month |
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University | Nashville | Tennessee | 37232 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | DBS Progamming From Atlas |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Fahn-Tolusa-Marsden Tremor Rating Scale | Tremor quantification | Data analysis was not completed because only one participant completed the DBS Programming from Atlas arm and disclosing data could violate privacy interests. | Posted | 1 month |
|
1 month
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
Not provided
Not provided
Unable to fully recruit for the study
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Fenna Phibbs | VUMC | 614-936-0060 | fenna.phibbs@vumc.org |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 17, 2012 | Jan 13, 2023 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D020329 | Essential Tremor |
| ID | Term |
|---|---|
| D009069 | Movement Disorders |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| 0 |
| 3 |
| 0 |
| 3 |
| 0 |
| 3 |
| EG001 | 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 | 0 | 1 | 0 | 1 | 0 | 1 |
Not provided
Not provided