Methylphenidate for the Treatment of Gait Impairment in Parkinson's Disease

• Status: Completed
• Trial end date: 2009-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this research study is to examine whether Methylphenidate (MPD) can result in improvement of gait (walking) in a population of Parkinson's Disease (PD) patients whose main disability is freezing of gait. MPD (Ritalin®) is a drug which can excite or stimulate certain systems of the body that control motor function. This drug is FDA approved for the treatment of attention hyperactivity disorder, a condition unrelated to PD.

The researchers hypothesize that daily treatment with a tolerable daily oral dose of MPD will improve gait velocity, stride length, cadence, and decrease freezing of gait, 3 months from treatment initiation in patients with moderately advanced PD, whose gait impairment is an important source of disability despite optimized antiparkinsonian treatment.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Cincinnati
• Collaborator: Michael J. Fox Foundation for Parkinson's Research
• Treatments: Methylphenidate

Criteria

Inclusion Criteria:

• Patients with a definite diagnosis of Parkinson's disease for at least 5 years.

• Patients with mild to severe gait disturbance.

• Patients on a stable dose of anti-parkinsonian medications that will not be expected to require medication adjustments.

• Mini-Mental State Examination (MMSE) score of 25 or greater.

Exclusion Criteria:

• Patients with musculoskeletal disorders such as severe arthritis, post knee surgery, hip surgery, or any other condition that the investigators determine may impair assessment of gait.

• Previous treatment with DBS (deep brain stimulation).

• Those with history of stroke.

• Those with cerebellar, vestibular, or sensory ataxia.

• Concurrent use of, or within two weeks from discontinuing, MAO inhibitor drugs (selegiline, rasagiline).

• Women of childbearing potential.