Phase 2 N=25 Randomized Double-blind Treatment

Transcranial Direct Current Stimulation to Treat Symptoms of Parkinson's Disease

Parkinson Disease

Bottom Line

View on ClinicalTrials.gov: NCT00082342 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2012

Primary outcome: Primary: Gait Speed Before and After Real and Sham tDCS. — 8.7; 8.6; 9.7; 9.5 Seconds

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Phoressor II (IOMED) (Device)
Age: Adult, Older Adult · 40+ yrs
Sex: All
Sponsor: National Institute of Neurological Disorders and Stroke (NINDS)
Primary completion: Feb 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Gait Speed Before and After Real and Sham tDCS.	8.7; 8.6; 9.7; 9.5; 7.2; 7.6	—
SECONDARY UPDRS Total Scores Before and After Real tDCS Course and After Sham tDCS Course.	42.5; 39.5; 58.4; 53.6; 36.9; 32.0	—
SECONDARY UPDRS Motor Scores Before and After Real tDCS Course and After Sham tDCS Course.	22.2; 17.5; 34.0; 26.5; 20.4; 15.6	—
SECONDARY Bradykinesia Measure Before and After Real and Sham tDCS.	12.3; 12.3; 14.5; 14.4; 8.5; 10.5	—

Summary

This study will examine the effects of transcranial direct current stimulation (tDCS) on gait (walking) problems and rigidity in patients with Parkinson's disease. tDCS 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) tDCS. Both groups will have eight treatments over 3-1/2 weeks. For the tDCS, 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 tDCS session. Patients' motor function will be re-evaluated at 1, 3, and 6 months after the last tDCS treatment. ...

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 2 to 4 while "off" will be accepted.

Patients must be on a regimen including levodopa. The total dose of levodopa and dopamine agonists (using dopamine equivalents) has to be equal to or more than 375 milligrams per day. Other anti-parkinsonian medications are also acceptable.

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

Exclusion criteria are any significant medical or psychiatric illnesses (except those symptoms often associated with PD or levodopa therapy, such as sundowning and benign hallucination), pallidotomy, implanted electrodes and generator for deep brain stimulation, pregnancy.

Persons with surgically 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. Most of these exclusions also come under the category of significant medical illness.

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00082342). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.