This study is an open-label study to determine the feasibility of Motor Cortex Stimulation
(MCS) in the treatment of patients with chronic pain of the face or upper extremity. MCS will
be delivered by use of an electrode and pulse generator, which are FDA approved for spinal
cord stimulation but are not approved for MCS. The study has as a single-arm design with the
subject at baseline serving as a control for the response to MCS.
1. Males and females who are greater than 18 years of age.
2. Subject has a diagnosis of chronic pain involving the face, upper extremity, or
throat, as determined by a review of medical records, history and physical
examination. The types of chronic pain eligible for the study are:
1. Facial pain, including trigeminal neuralgia Type 1, trigeminal neuralgia Type 2,
trigeminal neuropathic pain, trigeminal deafferentation pain, symptomatic
trigeminal neuralgia, and postherpetic neuralgia.
2. Complex Regional Pain Syndrome (Types I and II) involving the arm.
3. Both chronic and episodic forms of refractory Glossopharyngeal Neuralgia (GN).
4. Deafferentation of the cervical spine leading to pain of the upper extremity.
5. Central pain syndromes resulting from a prior cerebrovascular insult occurring at
least 5 years prior to the study.
3. Subject determined to be treatment-resistant for at least one year prior to the
Screening Visit as demonstrated by clinical evidence (determined by review of medical
records and discussion with referring pain specialist, anesthesiologist, or
neurologist treating chronic pain). The patient must not have responded to treatment
with three adequate regimens of medication including one in each of the following
categories: antiepileptic drugs, opioids, and antidepressant medications. The trial
period for each medication should be at least four weeks, and the two trials must be
within the previous 5 years.
4. Subject has at least a score of 6 on the Visual Analog Scale of Pain at all three
clinic visits prior to undergoing surgery.
5. Subject must be ambulatory.
6. Females who are postmenopausal, physically incapable of childbearing, or practicing an
acceptable method of birth control. Acceptable methods of birth control include
surgical sterilization, hormonal contraceptives, or double-barrier methods (condom or
diaphragm with a spermicidal agent or intrauterine device [IUD]). If practicing an
acceptable method of birth control, a negative urine pregnancy test result has been
obtained at baseline Visits 1 and 2.
7. Subject is assessed by psychologist with respect to i) the role of psychological
factors, including psychological comorbidities, in their chronic pain, ii) their
ability to rate pain and make decisions during the extraoperative stimulation trial,
and iii) to participate in decision-making capacity to provide informed consent.
8. Subject is able to read English, understand and cooperate with study procedures, and
has signed a written informed consent form prior to any study procedures.
1. Subject had major surgery within three months prior to Baseline Visit 1 or has other
surgery planned during the proposed study period.
2. Subject is determined by medical consultant to have medical contraindications to
3. Subject is pregnant or breast-feeding.
4. Subject has a history of alcohol or drug abuse within the past 6 months and dependence
within the past year.
5. Subject has a medical illness/condition, co-morbid psychiatric illness, and/or
abnormal diagnostic finding that would interfere with the completion of the study,
confound the results of the study, or pose risk to the patient.
6. Subject has a diagnosis of mental retardation.
7. Subject has a distinct neurological condition not included in the list of chronic pain
syndromes studied in this protocol, or a history of traumatic brain injury associated
with loss of consciousness of > 1 hour and/or intracranial/epidural/subdural bleeding.
8. Diagnosis of a somatoform pain disorder.