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

Parkinson's Disease Clinical Trial

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).

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02221544
• Other study ID #: TASMC-13-NG-599-CTIL
• Status: Not yet recruiting
• Phase: N/A
• First received: August 19, 2014
• Last updated: August 19, 2014
• Start date: September 2014
• Est. completion date: December 2016

Study information

• Verified date: August 2014
• Source: Tel-Aviv Sourasky Medical Center
• Contact: Nir Giladi, MD
• Phone: 972-3-6974790
• Email: nirg[@]tlvmc.gov.il
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: December 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 89 Years

Eligibility

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. -

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Device:
• Low-frequency repetitive Transcranial Magnetic Stimulation
Participants will receive treatment at a frequency of 3 sessions per week for 4 weeks (12 sessions). In each session patient will receive repetitive Transcranial Magnetic Stimulation using a stimulation frequency of 10 Hz for half an hour. The treatment is done by attaching an electromagnetic coil to the scalp using a special hat. Each patient has a personal hat which serves him throughout the entire process. The treatment is performed without anesthesia and patient fully conscious. During the treatment he sits comfortably on a chair, meanwhile the magnetic field passes through the skull into the brain.
• rTMS maintenance
Same treatment as in rTMS treatment intervention, but only once a week for a month
• Sham
Participants will receive sham treatment at a frequency of 3 sessions per week for 4 weeks (12 sessions total) for half an hour each session. The treatment is done by attaching an electromagnetic coil to the scalp but without turning on the magnetic field.
• Sham maintenance
The same as Sham stimuli intervention, but once a week for a month

Locations

Country	Name	City	State
Israel	Tel Aviv Sourasky Medical Center	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in frequency and severity of the freezing of gait phenomenon	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.	One week post intervention	No
Secondary	Community ambulation	Will be assessed using 1) the Habitual Physical Activity Questionnaire (HPAQ). It will quantify the type and amount of regular physical activity. 2) A body-worn small lightweight device that will be worn by the subject for 7 days to monitor stepping and physical activity.	One week post intervention	No
Secondary	Changes in endurance	This measure will be assessed using the 2 minute walk test. The distance walked during 2 minutes will be compared to baseline performance.	One week post intervention	No
Secondary	Balance	Balance and lower extremity function will be assessed using performance-based measures: (1) The Four Square Step Test (FSST), (2) The Short Physical Performance Battery (SPPB), and (3) The Mini- Balance Evaluation Systems Test (mini-BEST).	One week post intervention	No
Secondary	Immediate changes in blood pressure	Measuring blood pressure will monitor subjects' autonomic response to the treatment. Measures will be compared before and after receiving the treatment	Every session, immediately after receiving the treatment	Yes
Secondary	Immediate change in gait function	Gait speed and variability will be assessed under usual and dual task conditions and while negotiating physical obstacles, using a sensorized 7 meter carpet (PKMAS) and wearable body fixed sensors. These measures will be compared to baseline performance.	One week post intervention	No