The Effect of Low-frequency Repetitive Transcranial Magnetic Stimulation on Motor Function in Patients With Parkinson's Disease (PD) With Freezing of Gait (FOG).
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 20
- Locations
- 2
- Primary Endpoint
- Changes in frequency and severity of the freezing of gait phenomenon
Study Overview
Brief Summary
This study is a double blind comparative study examining the effectiveness of the rTMS treatment on Freezing of Gait (FOG) phenomenon in patients with Parkinson's disease. We hypothesize that treatment using rTMS stimulation on frontal lobe areas will improve gait quality and decrease the frequency of FOG in patients with Parkinson's disease.
Detailed Description
A course of low-frequency repetitive transcranial magnetic stimulation (rTMS) delivered over the supplementary motor area (SMA) improves motor symptoms in patients with Parkinson's disease (PD).
The present study is a comparative study that examines the effectiveness of rTMS treatment technique Freezing of Gait (FOG) phenomenon in Parkinson's disease patients. We hypothesize that treatment using rTMS stimulation on frontal areas will decreasing frequency of FOGs in patients with Parkinson's disease and improve gait quality and quality of life.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Eligibility Criteria
- Ages
- 50 Years to 89 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Idiopathic Parkinson's disease (PD), as diagnosed by a neurologist.
- •The mini-mental state examination questionnaire score above 24 points.
- •Suffer from a disabling phenomenon called Freezing of Gait (FoG) (Freezing Of Gait questionnaire score> = 10)
- •Negative responses to the Preliminary Safety Magnetic Stimulation Treatment questionnaire.
Exclusion Criteria
- •Other neurological or psychiatric disorders.
- •Severe personality disorder.
- •High Blood Pressure.
- •History of epilepsy, seizures or convulsions.
- •History of epilepsy or convulsions in first-degree relatives.
- •History of head injury or stroke.
- •Metal remains of the skull or inside the brain (outside the oral cavity).
- •Surgeries including metallic implants or known history of metal particles in the eye, pacemakers, hearing devices transplantation, or medical pumps.
- •Current history of migraines for the last six months.
- •A history of drug or alcohol abuse
- •Other medical research in the time to experiment or three months ahead. -
Outcomes
Primary Outcomes
Changes in frequency and severity of the freezing of gait phenomenon
Time Frame: One week post intervention
The new version of the Freezing of Gait questionnaire will be used to quantify the frequency and severity of this symptom. The score will be compared to baseline.
Secondary Outcomes
- Immediate changes in blood pressure(Every session, immediately after receiving the treatment)
- Community ambulation(One week post intervention)
- Changes in endurance(One week post intervention)
- Balance(One week post intervention)
- Immediate change in gait function(One week post intervention)
Investigators
michal roll
Director of the R&D division in the Tel Aviv Sourasky Medical Center (TASMC)
Tel-Aviv Sourasky Medical Center