Clinical trial NCT02221544: The Effect of Low-frequency rTMS on Motor Function in PD Patients With Freezing of Gait
Official title: The Effect of Low-frequency Repetitive Transcranial Magnetic Stimulation on Motor Function in Patients With Parkinson's Disease (PD) With Freezing of Gait (FOG).
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson's Disease
Keywords: Parkinson's disease, rTMS, Freezing of Gait
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2014-08-20
Enrollment: 20
Sex: ALL
Minimum age (years): 50
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Idiopathic Parkinson's disease (PD), as diagnosed by a neurologist.
2. The mini-mental state examination questionnaire score above 24 points.
3. Suffer from a disabling phenomenon called Freezing of Gait (FoG) (Freezing Of Gait questionnaire score\> = 10)
4. Negative responses to the Preliminary Safety Magnetic Stimulation Treatment questionnaire.

Exclusion Criteria:

1. Other neurological or psychiatric disorders.
2. Severe personality disorder.
3. High Blood Pressure.
4. History of epilepsy, seizures or convulsions.
5. History of epilepsy or convulsions in first-degree relatives.
6. History of head injury or stroke.
7. Metal remains of the skull or inside the brain (outside the oral cavity).
8. Surgeries including metallic implants or known history of metal particles in the eye, pacemakers, hearing devices transplantation, or medical pumps.
9. Current history of migraines for the last six months.
10. A history of drug or alcohol abuse
11. Other medical research in the time to experiment or three months ahead. -

Primary outcomes:
measure: Changes in frequency and severity of the freezing of gait phenomenon
timeFrame: One week post intervention
Secondary outcomes:
measure: Community ambulation
timeFrame: One week post intervention
measure: Changes in endurance
timeFrame: One week post intervention
measure: Balance
timeFrame: One week post intervention
measure: Immediate changes in blood pressure
timeFrame: Every session, immediately after receiving the treatment
measure: Immediate change in gait function
timeFrame: One week post intervention
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
Study officials:
affiliation: Tel-Aviv Sourasky Medical Center
name: Nir Giladi, MD
role: PRINCIPAL_INVESTIGATOR
References: