Parkinsonian DisordersNCT01853150
Repetitive Transcranial Magnetic Stimulation for Freezing of Gait
A study testing rTMS Motor cortex and rTMS Supplementary motor area in people with Parkinsonian Disorders, run by Dongtan Sacred Heart Hospital at 1 site in South Korea.
Trial summary
Freezing of gait (FOG) means that patients cannot walk without any known causes, other than parkinsonism, which is very disabling symptom. Patients descirbe their feeling of the feet suddenly being glued to the floor. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Parkinsonian Disorders
- What is being tested?
- rTMS Motor cortex and rTMS Supplementary motor area
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2013to Jul 2018
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Parkinson's disease or Primary progressive freezing of gait
- age 18 and older
- Freezing of gait
Who cannot join
- pregnant or any, other medical, surgical, neurological or psychiatric conditions
- other restrictions which prevent you from undergoing TMS recording, such as; surgically or traumatically implanted foreign bodies such as a pacemaker, an implanted medication pump, a metal plate in the skull, or metal inside the skull or eyes (other than dental appliances or fillings), and/ or heart/cardiac lines
- any past or current history of seizure disorder or epilepsy
- unable to give informed consent
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Dongtan Sacred Heart Hospital
Hwaseong-si, Gyeonggi-do, 445-170
About this study
Freezing of gait (FOG) means that patients cannot walk without any known causes, other than parkinsonism, which is very disabling symptom. Patients descirbe their feeling of the feet suddenly being glued to the floor. Transcranial magnetic stiumation is a noninvasive procedure using electromagnetic induction to stimulate brain. Transcranial magnetic stiumation (rTMS) can selectively change brain activity to enhance desired effects. The aim of this study is to the therapeutic effect of rTMS for the FOG.
- Conditions
- Parkinsonian Disorders
- Being tested
- rTMS Motor cortex, rTMS Supplementary motor area
- Medical subject headings
- Parkinsonian Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rTMS Motor cortexDevice
rTMS Supplementary motor areaDevice
| Study group | Role | What they receive |
|---|---|---|
| rTMS Motor cortex | Experimental | rTMS will be applied over the motor cortex Receives: Device: rTMS Motor cortex |
| rTMS Supplementary motor area | Active comparator | rTMS will be applied over the supplementary motor area Receives: Device: rTMS Supplementary motor area |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of steps
The number of steps during the stand-walk-sit (SWS) test
Measured: 2 days
Secondary outcomes (3)
The completion time during the SWS test
Measured: 2 days
Freezing episodes of gait trajectory
Measured: 2 days
Patient and Clinical Global Impression Scale
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2013 (estimated)
- Study startApr 2013
- Primary completionJul 2018
- Study completionJul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinsonian DisordersStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dongtan Sacred Heart Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suk Yun Kang, Dongtan Sacred Heart Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01853150
- Sponsor's protocol ID
- 2013-022
- Status last verified
- Jul 2018
- First submitted
- 10 May 2013
- Last updated
- 24 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repetitive Transcranial Magnetic Stimulation for Freezing of Gait
- ClinicalTrials.gov ID
- NCT01853150
- Acronym / sponsor ID
- 2013-022
- Conditions
- Parkinsonian Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Dongtan Sacred Heart HospitalUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Jul 2018 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 14 May 2013 (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.
Freezing of gait (FOG) means that patients cannot walk without any known causes, other than parkinsonism, which is very disabling symptom. Patients descirbe their feeling of the feet suddenly being glued to the floor. Transcranial magnetic stiumation is a noninvasive procedure using electromagnetic induction to stimulate brain. Transcranial magnetic stiumation (rTMS) can selectively change brain activity to enhance desired effects. The aim of this study is to the therapeutic effect of rTMS for the FOG.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rTMS Motor cortex | Experimental | Device: rTMS Motor cortexrTMS will be applied over the motor cortex |
| rTMS Supplementary motor area | Active comparator | Device: rTMS Supplementary motor arearTMS will be applied over the supplementary motor area |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Parkinson's disease or Primary progressive freezing of gait
- age 18 and older
- Freezing of gait
Key exclusion criteria (4 listed)
- pregnant or any, other medical, surgical, neurological or psychiatric conditions
- other restrictions which prevent you from undergoing TMS recording, such as; surgically or traumatically implanted foreign bodies such as a pacemaker, an implanted medication pump, a metal plate in the skull, or metal inside the skull or eyes (other than dental appliances or fillings), and/ or heart/cardiac lines
- any past or current history of seizure disorder or epilepsy
- unable to give informed consent
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 |
|---|---|---|
| rTMS Motor cortex | Device | rTMS Motor cortex |
| rTMS Supplementary motor area | Device | rTMS Supplementary motor area |
Primary outcome
The number of steps
Time frame: 2 days
The number of steps during the stand-walk-sit (SWS) test
3 secondary outcomes
The completion time during the SWS test
Time frame: 2 days
Freezing episodes of gait trajectory
Time frame: 2 days
Patient and Clinical Global Impression Scale
Time frame: 2 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rTMS Motor cortex and rTMS Supplementary motor area in people with Parkinsonian Disorders, run by Dongtan Sacred Heart Hospital at 1 site in South Korea.
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 3 inclusion and 4 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: finished, as of the sponsor's last update on 24 Jul 2018. 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 South Korea. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of steps (time frame: 2 days). 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 24 Jul 2018.