Microelectrode-based brain stimulation for Parkinson’s and essential tremor

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This first-in-human study explores high definition brain stimulation (HDBS) to better target neural tissue with fewer side effects. Researchers map responsive brain areas using stimulation depths and contacts, then compare with later assessments after permanent DBS leads are in place. The goal is to identify sites that provide strong therapeutic effects with minimal adverse effects and to estimate the likelihood of success across patients. The study continually analyzes data from multiple patients to refine which stimulation configurations may work best. Locations involved include Lund University and Skane University Hospital in Sweden.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* The target population for the clinical device to be investigated are adult patients with Parkinson's disease or essential tremor that are already scheduled for permanent implantation of devices for deep brain stimulation. This implies that these patients are an already selected group of patients deemed to be appropriate patients for DBS.
* Patients that are fully capable of understanding the patient information.
* Patients that accept to be awake during the investigation
* Patients that accept to be video-filmed during the investigation.

Exclusion Criteria:

* Patients that do not accept to be awake during the stimulation procedure.
* Patients for which the intended extension of surgery time (up to 2,5 hours) is considered by the neurosurgeon to be an unacceptable risk.
* Patients with a known history of blood clotting disorder.
* Patients with a known history of bleeding disorder.
* Patients under age 18.
* Pregnant women and women that are breast feeding.

Where it's running

• Skane University Hospital
  Lund, Skåne County, Sweden Recruiting

Study contacts

• Study coordinator: Jens Schouenborg, PhD
• Email: jens.schouenborg@med.lu.se
• Phone: +46702924572

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.