Lund University Registers a Human Trial of Microelectrode Brain Stimulation
Lund University Registers a Human Trial of Microelectrode Brain Stimulation
On September 15, entry NCT07820189 appeared in the ClinicalTrials.gov registry: Lund University plans to enroll up to 12 adults with Parkinson's disease or essential tremor who have already been scheduled for deep brain stimulation. The study status is "not yet recruiting."
Deep brain stimulation (DBS) is a method in which a surgeon implants a permanent electrode into a deep brain structure and connects it to a pulse generator. The sites where stimulation relieves symptoms or causes adverse effects can vary from patient to patient.
HDBS is a temporary cluster of thin, flexible microelectrodes. It is inserted into the brain of an awake patient along the same trajectory that will later be used to place the permanent DBS electrode. Assessment of a single patient will take up to 2.5 hours.
At four preselected depths, the physician will test groups of microelectrodes and gradually increase the current until a therapeutic effect or an adverse reaction appears. Each test will be linked to the site, depth, current amplitude, and the patient's response: changes in tremor, rigidity, speech, gestures, or facial expression. The primary objective is to determine whether the selected group of microelectrodes produces meaningful symptom relief with minimal adverse effects.
After the measurements, the temporary cluster is removed and the permanent electrode is implanted. Three to eight weeks later, the team will evaluate how stimulation through different contacts on that electrode affects the same patient and compare the results with the map obtained during surgery. In this way, the study will test whether the intraoperative map predicts the effect of chronic DBS.