Parkinson's DiseaseNCT02221544
The Effect of Low-frequency rTMS on Motor Function in PD Patients With Freezing of Gait
A study testing Low-frequency repetitive Transcranial Magnetic Stimulation and rTMS maintenance in people with Parkinson's Disease, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
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… Read more about this study
- Who is it for?
- Ages 50 to 89 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Low-frequency repetitive Transcranial Magnetic Stimulation and rTMS maintenance
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2014to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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. -
Trial locations and contacts
1 site in 1 country.
Israel1 site
Tel Aviv Sourasky Medical Center
Tel Aviv, 64239
Nir Giladi, MD, 972-3-6974790, nirg@tlvmc.gov.il
Anat Mirelman, PhD, 972-3-6974958, anatmi@tlvmc.gov.il
About this study
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).
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.
Read the 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.
- Conditions
- Parkinson's Disease
- Being tested
- Low-frequency repetitive Transcranial Magnetic Stimulation, rTMS maintenance, Sham, Sham maintenance
- Keywords
- Parkinson's disease, rTMS, Freezing of Gait
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-frequency repetitive Transcranial Magnetic StimulationDevice
Also called rTMS treatment
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 maintenanceDevice
Same treatment as in rTMS treatment intervention, but only once a week for a month
ShamDevice
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 maintenanceDevice
The same as Sham stimuli intervention, but once a week for a month
| Study group | Role | What they receive |
|---|---|---|
| rTMS treatment followed by Sham | Experimental | 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 Receives: Device: Low-frequency repetitive Transcranial Magnetic Stimulation; Device: rTMS maintenance; Device: Sham; Device: Sham maintenance |
| Sham treatment followed by rTMS | Experimental | 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 Receives: Device: Low-frequency repetitive Transcranial Magnetic Stimulation; Device: rTMS maintenance; Device: Sham; Device: Sham maintenance |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One week post intervention
Secondary outcomes (5)
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.
Measured: One week post intervention
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.
Measured: One week post intervention
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).
Measured: One week post intervention
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
Measured: Every session, immediately after receiving the treatment
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.
Measured: One week post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2014 (estimated)
- Study startSep 2014
- Primary completionDec 2015 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, michal roll, Tel-Aviv Sourasky Medical Center
- Investigators
- Nir Giladi, MD, Principal investigator, Tel-Aviv Sourasky Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02221544
- Sponsor's protocol ID
- TASMC-13-NG-599-CTIL
- Status last verified
- Aug 2014
- First submitted
- 19 Aug 2014
- Last updated
- 20 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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).
- ClinicalTrials.gov ID
- NCT02221544
- Acronym / sponsor ID
- TASMC-13-NG-599-CTIL
- Conditions
- Parkinson's Disease
- Keywords
- Parkinson's disease, rTMS, Freezing of Gait
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Sep 2014
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 20 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rTMS treatment followed by Sham | Experimental | Device: Low-frequency repetitive Transcranial Magnetic Stimulation, Device: rTMS maintenance, Device: Sham, Device: Sham maintenanceA 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 |
| Sham treatment followed by rTMS | Experimental | Device: Low-frequency repetitive Transcranial Magnetic Stimulation, Device: rTMS maintenance, Device: Sham, Device: Sham maintenanceA 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 |
Who may qualify
- Ages
- 50 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-frequency repetitive Transcranial Magnetic StimulationAlso: rTMS treatmentParticipants 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. | Device | Sham treatment followed by rTMS, rTMS treatment followed by Sham |
| rTMS maintenanceSame treatment as in rTMS treatment intervention, but only once a week for a month | Device | Sham treatment followed by rTMS, rTMS treatment followed by Sham |
| ShamParticipants 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. | Device | Sham treatment followed by rTMS, rTMS treatment followed by Sham |
| Sham maintenanceThe same as Sham stimuli intervention, but once a week for a month | Device | Sham treatment followed by rTMS, rTMS treatment followed by Sham |
Primary outcome
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.
5 secondary outcomes
Community ambulation
Time frame: One week post intervention
Changes in endurance
Time frame: One week post intervention
Balance
Time frame: One week post intervention
Immediate changes in blood pressure
Time frame: Every session, immediately after receiving the treatment
Immediate change in gait function
Time frame: One week post intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nir Giladi, MD principal investigator
Tel-Aviv Sourasky Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-frequency repetitive Transcranial Magnetic Stimulation and rTMS maintenance in people with Parkinson's Disease, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nir Giladi, MD (972-3-6974790, nirg@tlvmc.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in frequency and severity of the freezing of gait phenomenon (time frame: One week post intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2014.