Protocol Number: 03-N-0116

Title:

Transcranial Electrical Polarization for the Treatment of Bradykinesia and Rigidity in Patients with Parkinson's Disease.

Number:

03-N-0116

Summary:

This study will examine the effects of transcranial electrical polarization (TEP) on gait (walking) problems and rigidity in patients with Parkinson's disease. TEP is a method of brain stimulation that may be able to change the electrical activity of the nerves of the brain, possibly causing Parkinson's disease symptoms to improve.

Patients between 40 and 80 years of age with moderately severe Parkinson's disease whose main symptoms are problems with walking, including freezing, or rigidity, may be eligible for this study. Candidates must be taking Sinemet or another L-DOPA drug and not have too much tremor.

Participants will be assigned to receive either real or sham (placebo) TEP. Both groups will have eight treatments over 3-1/2 weeks. For the TEP, electrodes are placed on wet pads on the scalp. An electrical current passes through the electrodes, travels through the scalp and skull, and causes small electrical currents in the cortex-the outer part of the brain. Participants will have a neurological examination, including an evaluation of walking, just before and just after each TEP session. Patients' motor function will be re-evaluated at 1, 3, and 6 months after the last TEP treatment.

Sponsoring Institute:

National Institute of Neurological Disorders and Stroke (NINDS)

Recruitment Detail

Type: Active Accrual Of New Subjects

Gender: Male & Female

Referral Letter Required: Yes

Population Exclusion(s): Children

Eligibility Criteria:

INCLUSION CRITERIA:

Patients with PD corresponding to inclusion criteria will be recruited from the Human Motor Control Section Clinic (HMCS).

Subjects will be men and women aged 40-80 years with DOPA-responsive, akinetic-rigid PD.

Patients who have never participated in HMCS protocols for PD will be interviewed and examined by either the principal investigator or a physician from the Brain Stimulation Unit or HMCS in order to establish the diagnosis of PD and rule out any neurological condition. Only patients with a Hoehm and Yahr grade of 3 to 4 while "off" will be accepted.

Patients must be on a regimen including levodopa and have a total dose of levodopa equal to or more than 375 milligrams per day; they also can be taking other anti-parkinsonian medications including direct dopamine agonists.

Patients should have problems with walking, including freezing, so that their gait time for a 10-meter distance will be six seconds or more.

EXCLUSION CRITERIA:

Any significant medical or psychiatric illness (other than PD), pallidotomy, implanted electrodes and generator for deep brain stimulation, pregnancy, history of epilepsy, concurrent use of tricyclic antidepressants, neuroleptic agents, or any other licit or illicit drugs other than antiparkinsonian agents that could lower the seizure threshold.

Persons with surgical or traumatically implanted foreign bodies such as a pacemaker, implanted medical pump, implanted hearing aids, metal plate in the skull, or metal implant in the skull or eyes (other than dental appliances or fillings) that may pose a physical hazard during TEP will also be excluded.

Patients for whom participation in the study would, in the opinion of the investigators, cause undue risk or stress for reasons such as tendency to fall, excessive fatigue, general frailty, or excessive apprehensiveness will also be excluded.

Patients unable to walk a 10-meter distance will be excluded.

Mentally impaired patients having no capacity to provide their own consent will be excluded from the study.

Special Instructions: Currently Not Provided

Keywords:

Human Brain

Electrical Stimulation

Recruitment Keywords:

Parkinson Disease

PD

Conditions:

Parkinson Disease

Investigational Drug(s):

None

Investigational Device(s):

None

Contacts:

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citations:

Agnew WF, McCreery DB. Considerations for safety in the use of extracranial stimulation for motor evoked potentials. Neurosurgery. 1987 Jan;20(1):143-7. PMID: 3808255

Antal A, Nitsche MA, Paulus W. External modulation of visual perception in humans. Neuroreport. 2001 Nov 16;12(16):3553-5. PMID: 11733710

Braun BL. Treatment of an acute anterior disk displacement in the temporomandibular joint. A case report. Phys Ther. 1987 Aug;67(8):1234-6. PMID: 3615594

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