The Effect of Low-frequency rTMS on Motor Function in PD Patients With Freezing of Gait

Tel Aviv Sourasky Medical Center

Status: Unknown

Conditions: Parkinson's Disease

Treatments: Device: Low-frequency repetitive Transcranial Magnetic Stimulation; Device: Sham maintenance; Device: Sham; Device: rTMS maintenance

Study type: Interventional

Funder types: Other

Identifiers

NCT02221544

TASMC-13-NG-599-CTIL

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 50 to 89 years old

Volunteers: No Healthy Volunteers

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. -

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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20 participants in 2 patient groups

rTMS treatment followed by Sham

Experimental group

Description:

A course of low-frequency repetitive transcranial magnetic stimulation (rTMS) delivered over the supplementary motor area (SMA) followed by rTMS maintenance period (1 month) and followed by sham treatment in order to show the efficacy of treatment

Treatment:

Device: rTMS maintenance

Device: Sham

Device: Sham maintenance

Device: Low-frequency repetitive Transcranial Magnetic Stimulation

Sham treatment followed by rTMS

Experimental group

Description:

A course of sham followed by followed by sham maintenance period (1 month) and than followed by low-frequency repetitive transcranial magnetic stimulation (rTMS) delivered over the supplementary motor area (SMA) in order to show the effectiveness of rTMS

Treatment:

Device: rTMS maintenance

Device: Sham

Device: Sham maintenance

Device: Low-frequency repetitive Transcranial Magnetic Stimulation