Intraoperative Investigation of a Directional Lead and Local Field Potentials for the Optimization of Stimulation Efficacy
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 2/7/2019 |
| Start Date: | July 12, 2018 |
| End Date: | December 31, 2019 |
| Contact: | Filippo Agnesi |
| Email: | filippo.agnesi@abbott.com |
| Phone: | 972-526-4860 |
The current study aims to explore the functional use of LFPs recorded intraoperatively for
the optimization of a directional DBS lead programming
Aim-1: To determine whether intraoperative LFPs recorded from the segmented DBS electrode can
predict the optimal stimulation parameters.
Aim-2: Compare the therapeutic window for stimulation delivered through directional and
conventional leads and determine if the spatiospectral LFP patterns correlate with the
presence of stimulation side effects.
the optimization of a directional DBS lead programming
Aim-1: To determine whether intraoperative LFPs recorded from the segmented DBS electrode can
predict the optimal stimulation parameters.
Aim-2: Compare the therapeutic window for stimulation delivered through directional and
conventional leads and determine if the spatiospectral LFP patterns correlate with the
presence of stimulation side effects.
This is a feasibility study designed to evaluate the usefulness of intraoperative LFP
recordings obtained from the implanted DBS lead to predict ideal stimulation parameters.
Additionally this study will compare the therapeutic window for stimulation delivered through
directional and conventional leads and determine if the spatiospectral LFP patterns correlate
with the presence of stimulation side effects.
Approximately 8 subjects will be enrolled in this clinical investigation. The clinical
investigation will be conducted at 2 centers in the USA.
Subjects participating in this clinical investigation will monitored during DBS implant
procedure and programming. The expected duration of enrollment is 8 months. The total
duration of the clinical investigation is expected to be 1 year.
recordings obtained from the implanted DBS lead to predict ideal stimulation parameters.
Additionally this study will compare the therapeutic window for stimulation delivered through
directional and conventional leads and determine if the spatiospectral LFP patterns correlate
with the presence of stimulation side effects.
Approximately 8 subjects will be enrolled in this clinical investigation. The clinical
investigation will be conducted at 2 centers in the USA.
Subjects participating in this clinical investigation will monitored during DBS implant
procedure and programming. The expected duration of enrollment is 8 months. The total
duration of the clinical investigation is expected to be 1 year.
Inclusion Criteria:
- Patient currently enrolled in the PROGRESS study
- Age 18-70 years
- Ability to provide informed consent
- Diagnosis of idiopathic Parkinson's disease, and DBS consensus team review supporting
the placement of STN DBS.
Exclusion Criteria:
- Subject is not a surgical candidate;
- In the Investigator's opinion the subject unable to tolerate multiple programming
sessions within a single setting;
- Subject unable to comply with the follow-up schedule
We found this trial at
1
site
Houston, Texas 77030
Phone: 713-798-8259
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