Optimizing Rehabilitation Effect with Electrical Stimulation Therapy Rehab

Overview

About this study

The purpose of this study is to evaluate the safety and effectiveness of deep brain stimulation (DBS) of the dentate nucleus area for improving functional status in patients with moderate to severe residual upper-extremity motor impairment due to stroke.

 

 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Supratentorial ischemic stroke, with an initial incident occurring between 12 months to 6 years before implant, resulting in residual upper extremity hemiparesis. (Enrollment for screening may occur as early as 6 months; see §5.4.1 Enrollment).
  • Fugl-Myer Assessment, Upper Extremity subscale (FMA-UE) ≤ 44.
  • Active extension of the wrist and two other digits plus active thumb abduction/extension, repeatable three times (3x).
  • Age ≥ 22 years.
  • Capacity to provide written informed consent (no surrogate or proxy).
  • Able to adequately communicate and complete questionnaires provided in English.
  • Able to use a mobile rehabilitation therapy application (e.g., tablet or iPad telehealth platform).

Exclusion Criteria:

  • Previous or subsequent cerebrovascular events resulting in residual upper extremity impairment. Cerebrovascular events occurring within 30 days after the initial event are allowed unless located in a notably different territory than the initial event.
  • Brain lesions with significant involvement of the brainstem, cerebellum, or thalamus.
  • Clinically significant bilateral brain lesions.
  • Botox (or any anti-spasticity injection) in affected arm ≤ 3 months.
  • Modified Ashworth Spasticity scale (MAS) ≥ 4 for shoulder internal rotation and adduction, elbow flexion, wrist flexion, finger flexion, or pronation.
  • Pain that will prevent the completion of a 120-minute rehabilitation therapy session.
  • Contracture in the affected upper extremity preventing an adequate passive range of motion (ROM) for rehabilitation therapy tasks.
  • Star Cancellation Test (SCT) < 44 (i.e., unilateral spatial neglect).
  • Contraindication to MRI or a condition requiring MRI or diathermy while the device is implanted.
  • Medical contraindications to surgery, including but not limited to: chronic uncontrolled high blood pressure, history of severe cardiovascular disease, and cardiac arrhythmias with hemodynamic instability.
  • Inability to perioperatively discontinue drugs that affect clotting, including antiplatelet or anticoagulant.
  • Diagnosis of epilepsy, not including seizures occurring within 30 days after the initial event of the stroke.
  • Diagnosis of a progressive neurological disease such as multiple sclerosis (MS) or Alzheimer’s.
  • Untreated substance use disorder in the past 12 months.
  • Severe anxiety defined as Beck Anxiety Inventory (BAI) > 36.
  • Severe depression defined as Beck Depression Inventory-II (BDI-II) ≥ 29.
  • Mild to severe dementia defined as Mini-Mental State Exam (MMSE) < 24.
  • Diagnosis or untreated severe psychiatric disorder.
  • Modified Rankin Scale score (mRS) ≥ 4 (i.e., inability to selfcare).
  • Apraxia swallowing, dysphagia, or aspiration.
  • Life expectancy less than 12 months, for example, chronic kidney disease ≥ stage IV, or cancer with poor prognosis (e.g., CLL, CML, etc.).
  • Participating in another investigational drug, investigational device, or physical intervention that may influence or interfere with the data collected for this study.
  • Other active implantable devices, such as pacemakers, cardioverter defibrillators, or medication delivery pumps that may interfere with the operation of the study device.
  • Women of child-bearing potential who are not using adequate birth control, are pregnant, or intend to become pregnant during the study.
  • A significant condition that, in the opinion of the investigator, significantly reduces study safety or interferes with study outcomes or compliance (incl. unresolved issues of secondary gain).

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 1/31/24. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Rushna Ali, M.D.

Open for enrollment

Contact information:

Adam Loudermilk

(507) 422-0718

Loudermilk.Adam@mayo.edu

More information

Publications

Publications are currently not available