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 @ 7:39 PM
Ignite Modification Date:
2025-12-24 @ 7:39 PM
NCT ID:
NCT04043403
Eligibility Criteria:
Inclusion Criteria:
* Clinically-established PD
* Meets criteria for STN DBS eligibility as part of patient's standard medical care or already implanted in the STN with Percept(TM) PC
* The presence of complications of medication such as wearing off signs, fluctuating responses and/or dyskinesias, and/or medication refractory tremor, and/or impairment in the quality of life on or off medication due to these factors.
* Ability and willingness to return for study visits, at the initial programming and after three, six and twelve months of DBS.
* Age \> 18
* Freezing of gait questionnaire (FOG-Q) score ≥ 1 and/or gait sub-score (Item 3.10) of MDS- UPDRS III ≥ 1
* Greater than or equal to 1.2 microVp between 8-35 Hz on either the LSTN or RSTN (Percept (TM) PC cohort only)
Exclusion Criteria:
* Dementia
* Untreated psychiatric disease
* Hoehn and Yahr stage 5 on or off medication (non-ambulatory)
* Age \> 80
* Major surgical morbidities such as severe hypertension, coagulopathy and certain metabolic conditions that might increase the risk of hemorrhage or other surgical complications
* Presence of a cardiac pacemaker/defibrillator
* Inability to understand/sign consent
* Requires rTMS, ECT, MRI (Summit(R) RC+S cohort only), or diathermy
* Are pregnant or lactating
* Has a cranial metallic implant
* History of seizures or epilepsy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT04043403
Study Brief:
Protocol Section:
NCT04043403