Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:59 PM
Ignite Modification Date:
2025-12-24 @ 9:59 PM
NCT ID:
NCT00792532
Eligibility Criteria:
Parkinson's Disease
Inclusion Criteria:
1. Diagnosis of idiopathic PD with clinically significant motor fluctuations despite maximized anti-Parkinsonian therapy. This will be based on medical history, neurologic examination (the presence of at least 2 of the following: resting tremor, rigidity, or bradykinesia), and response to anti-Parkinsonian therapy.
2. Approximately 5 years' duration, relative to the date of surgery, since diagnosis of PD.
3. Age \>20 inclusive, on date of surgery.
4. The subject is ambulatory in their best on time (not wheelchair bound).
5. The subject is medically able to undergo the surgery as determined by clinical and laboratory evaluations and any other evaluations that are part of the standard practice at the institution in which the subject is to undergo surgery (e.g., subjects will have normal coagulation tests and normal platelet levels).
6. The subject is expected to be able to comply with and understand the required visit schedule and all required tests and procedures.
7. Signed IRB-approved informed consent is obtained before any study-specific procedure, including assessments required during the eligibility evaluation period.
Exclusion Criteria:
1. In the judgment of the investigator, a history of any clinically significant medical, psychiatric, or laboratory abnormality for which participation in the study would pose a safety risk to the subject.
2. History of treatment of PD by any procedure involving intracranial surgery or implantation of a device.
3. MRI of the brain within 12 months before the surgery which demonstrates an intracranial abnormality that would contraindicate surgery (e.g. stroke, tumor, vascular abnormality affecting the DBS target area).
4. Any disorder that precludes a surgical procedure (e.g., signs of sepsis or inadequately treated infection) or alters wound healing.
5. Receipt of antiplatelet agents for at least 10 days prior surgery.
6. Significant cognitive impairment based on investigator assessment during the eligibility evaluation period.
7. History of significant psychiatric illness, epilepsy, or Alzheimer's disease.
8. Active drug or alcohol abuse.
9. Pregnancy or lack of effective contraception in women of childbearing potential defined as one year post-menopausal or surgically sterile.
10. Treatment with non anti-Parkinsonian agents (e.g., atypical neuroleptics) that may affect symptoms of PD within 60 days before entering the study.
11. Any medical disability (e.g., severe degenerative arthritis, compromised nutritional state, severe peripheral neuropathy) that would interfere with the assessment of safety and efficacy in this trial.
12. Inability to follow-up with post-operative study visits
13. Inability to speak or read English
Dystonia Inclusion Criteria
1. Dystonia diagnosed by a movement disorders neurologist
2. Significant functional impairment despite optimal medical management, including failed botulinum toxin therapy if appropriate
3. Age \>20 years inclusive, on date of surgery.
4. The subject is medically able to undergo the surgery as determined by clinical and laboratory evaluations and any other evaluations that are part of the standard practice at the institution in which the subject is to undergo surgery (e.g., subjects will have normal coagulation tests and normal platelet levels).
5. The subject is able to comply with and understand the required visit schedule and all required tests and procedures.
6. Signed IRB-approved informed consent is obtained before any study-specific procedure, including assessments required during the eligibility evaluation period.
Exclusion Criteria
1. Any disorder that precludes a surgical procedure (e.g., signs of sepsis or inadequately treated infection) or alters wound healing.
2. Receipt of antiplatelet agents for at least 10 days prior surgery.
3. Significant cognitive impairment based on investigator assessment during the eligibility evaluation period.
4. History of significant psychiatric illness, epilepsy, or Alzheimer's disease.
5. Active drug or alcohol abuse.
6. Pregnancy or lack of effective contraception in women of childbearing potential defined as one year post-menopausal or surgically sterile.
7. Any medical disability (e.g., severe degenerative arthritis, compromised nutritional state, severe peripheral neuropathy) that would interfere with the assessment of safety and efficacy in this trial.
8. Inability to follow-up with post-operative study visits
9. Inability to speak or read English
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT00792532
Study Brief:
Protocol Section:
NCT00792532