Best results are achieved when the patient and caregiver are fully informed about the therapy risks and probable benefits, surgical procedures, follow-up requirements, and self-care responsibilities.

Deep brain stimulation may be considered when a patient with chronic, primary dystonia* cannot successfully manage symptoms with medication.

Deep brain stimulation may be appropriate if the patient:

  • Has chronic, primary dystonia, including generalized and segmental dystonia, hemidystonia, and cervical dystonia (torticollis)
  • Cannot successfully manage symptoms with medication
  • Is 7 years of age or older
  • Is a suitable candidate for stereotactic neurosurgery

Use extreme care with lead implantation in patients with a heightened risk of intracranial hemorrhage. Physicians should consider underlying factors, such as previous neurological injury or prescribed medications (anticoagulants), that may predispose a patient to the risk of bleeding.

Physicians should be aware that the risks associated with initial surgery may increase with clinical conditions such as:

  • Stroke or neurological disorders
  • Cardiovascular disease
  • Renal or hepatic failure
  • Diabetes mellitus

To help ensure maximum benefits from the neurostimulation system, long-term, post-surgical management of patients is recommended.

Stimulation parameters should be adjusted such that maximal symptom suppression is achieved with minimal side effects. High parameter values may indicate a system problem or less than optimal lead placement. Patients should be informed of the risks of higher parameters, which may result in possible excessive change density, as noted in the appropriate information for prescribers booklet.