Parkinson's DiseaseNCT01884493
Electrophysiological Investigation and rTMS Intervention of Ambulatory Central Processing of Freezing of Gait in Parkinson's Disease
A study testing real iTBS in people with Parkinson's Disease and Parkinson's Disease With Freezing of Gait, run by China Medical University Hospital at 1 site in Taiwan.
Trial summary
The gait symptoms are usually refractory to the dopaminergic agents and some other resolutions, i.e. repetitive transcranial magnetic stimulation (rTMS) should be searched for in this regard. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Parkinson's Disease, Parkinson's Disease With Freezing of Gait
- What is being tested?
- real iTBS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2014to Jul 2014
- 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 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with PD will be diagnosed according to the Brain Bank criteria.
Who cannot join
- Patients had past history of epilepsy, intracranial operation or brain tumor.
- Hoehn \& Yahr Stage V.
Trial locations and contacts
1 site in 1 country.
About this study
The gait symptoms are usually refractory to the dopaminergic agents and some other resolutions, i.e. repetitive transcranial magnetic stimulation (rTMS) should be searched for in this regard. To study the impact of rTMS, investigators will adopt a domestically developed ambulatory recorder (PK-16CH EXG) for the concomitant recording of the electroencephalographic and electromyographic signals for PD patients when walking in the gait laboratory or when conducting leg dorsiflexion movement on sitting.
Read the detailed description
The Bereitschaftspotential (BP), event related synchronization (ERS) and event related dysynchronization (ERD) will be analyzed for the investigation of the possible differences of brain activities prior to leg voluntary movement between patients and controls. In addition, the synchronized recorded gait parameters for gait ignition,turning and termination will also be analyzed. The information gathered will allow us to further understand the pathophysiology of the gait freezing in PD. Investigators will deliver a course of rTMS with intermittent theta burst paradigm of the leg motor cortex to investigate whether the non-invasive brain stimulation can ameliorate the gait freezing in PD patients. The subjects will be assessed before and 4 times after rTMS during an 8-week period with clinical scoring batteries and electrophysiological recording as aforementioned. At the end of the 8th week, the test group and sham group will cross over and undergo the same procedures as aforementioned. The serial comprehensive investigations in this project will not only promote our understanding of the gait freezing pathophysiology but also may charge a novel trail for the management of long suffering symptom of the PD patients.
- Being tested
- real iTBS, sham iTBS
- Keywords
- Parkinson's Disease, Freezing of Gait, movement-related cortical potential, repetitive transcranial magnetic stimulation
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
real iTBSDevice
Theta-burst magnetic stimulation (TBS) is a repetitive transcranial magnetic stimulation (rTMS) technique that elicits long-lasting changes in the excitability of human primary motor cortex (M1).
sham iTBSDevice
The sham test will be done by transferring the double cone coil 90 degrees anteriorly and putting the lower edge of the coil of the vertex.
| Study group | Role | What they receive |
|---|---|---|
| real iTBS | Experimental | The paradigm will use a theta burst stimulation pattern (TBS) in which 3 pulses of stimulation will be given at 50Hz, repeated every 200 ms. In the iTBS, a 2-second train of TBS is repeated every 10 seconds for a total of 190 seconds (600 pulses). Subjects will be 8 courses of iTBS stimulation in 10 business days. Receives: Device: real iTBS; Device: sham iTBS |
| sham iTBS | Sham comparator | Subjects will be 8 courses of sham iTBS stimulation in 10 business days. Receives: Device: real iTBS; Device: sham iTBS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Laboratory gait analysis after 8 courses of iTBS
Variables in gait analysis:1.Gait initiation; 2.Level walking; 3.Turning; 4.Gait termination.
Measured: baseline to week 8
Secondary outcomes (7)
Change in Unified Parkinson's Disease Rating Scale (UPDRS) after 8 courses of iTBS
Measured: baseline to week 8
Change in The 39-item Parkinson's Disease Questionnaire (PDQ-39) after 8 courses of iTBS
Measured: baseline to week 8
Change in Fall assessment test after 8 courses
Measured: baseline to week 8
Change in Tinetti's Mobility Index after 8 courses of iTBS
Measured: baseline to week 8
Change in new freezing of gait questionnaire (FOG-Q) after 8 courses
Measured: baseline to week 8
Change in Patients' Global Impressions of Change (PGIC) Scale after 8 courses of iTBS
Measured: baseline to week 8
Change in Clinical Global Impressions (CGI) after 8 courses of iTBS
Measured: baseline to week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2013 (estimated)
- Study startJan 2014
- Primary completionJul 2014
- Study completionJul 2014
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.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Responsible party
- Principal investigator, Chon-Haw Tsai, China Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01884493
- Sponsor's protocol ID
- CMUH102-REC1-002
- Status last verified
- Jan 2014
- First submitted
- 19 Jun 2013
- Last updated
- 8 Aug 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrophysiological Investigation and rTMS Intervention of Ambulatory Central Processing of Freezing of Gait in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT01884493
- Acronym / sponsor ID
- CMUH102-REC1-002
- Keywords
- Parkinson's Disease, Freezing of Gait, movement-related cortical potential, repetitive transcranial magnetic stimulation
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Study start
- Jan 2014
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 24 Jun 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.
The gait symptoms are usually refractory to the dopaminergic agents and some other resolutions, i.e. repetitive transcranial magnetic stimulation (rTMS) should be searched for in this regard. To study the impact of rTMS, investigators will adopt a domestically developed ambulatory recorder (PK-16CH EXG) for the concomitant recording of the electroencephalographic and electromyographic signals for PD patients when walking in the gait laboratory or when conducting leg dorsiflexion movement on sitting.
Detailed description
The Bereitschaftspotential (BP), event related synchronization (ERS) and event related dysynchronization (ERD) will be analyzed for the investigation of the possible differences of brain activities prior to leg voluntary movement between patients and controls. In addition, the synchronized recorded gait parameters for gait ignition,turning and termination will also be analyzed. The information gathered will allow us to further understand the pathophysiology of the gait freezing in PD. Investigators will deliver a course of rTMS with intermittent theta burst paradigm of the leg motor cortex to investigate whether the non-invasive brain stimulation can ameliorate the gait freezing in PD patients. The subjects will be assessed before and 4 times after rTMS during an 8-week period with clinical scoring batteries and electrophysiological recording as aforementioned. At the end of the 8th week, the test group and sham group will cross over and undergo the same procedures as aforementioned. The serial comprehensive investigations in this project will not only promote our understanding of the gait freezing pathophysiology but also may charge a novel trail for the management of long suffering symptom of the PD patients.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| real iTBS | Experimental | Device: real iTBS, Device: sham iTBSThe paradigm will use a theta burst stimulation pattern (TBS) in which 3 pulses of stimulation will be given at 50Hz, repeated every 200 ms. In the iTBS, a 2-second train of TBS is repeated every 10 seconds for a total of 190 seconds (600 pulses). Subjects will be 8 courses of iTBS stimulation in 10 business days. |
| sham iTBS | Sham comparator | Device: real iTBS, Device: sham iTBSSubjects will be 8 courses of sham iTBS stimulation in 10 business days. |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with PD will be diagnosed according to the Brain Bank criteria.
Key exclusion criteria (2 listed)
- Patients had past history of epilepsy, intracranial operation or brain tumor.
- Hoehn \& Yahr Stage V.
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 |
|---|---|---|
| real iTBSTheta-burst magnetic stimulation (TBS) is a repetitive transcranial magnetic stimulation (rTMS) technique that elicits long-lasting changes in the excitability of human primary motor cortex (M1). | Device | real iTBS, sham iTBS |
| sham iTBSThe sham test will be done by transferring the double cone coil 90 degrees anteriorly and putting the lower edge of the coil of the vertex. | Device | real iTBS, sham iTBS |
Primary outcome
Change in Laboratory gait analysis after 8 courses of iTBS
Time frame: baseline to week 8
Variables in gait analysis:1.Gait initiation; 2.Level walking; 3.Turning; 4.Gait termination.
7 secondary outcomes
Change in Unified Parkinson's Disease Rating Scale (UPDRS) after 8 courses of iTBS
Time frame: baseline to week 8
Change in The 39-item Parkinson's Disease Questionnaire (PDQ-39) after 8 courses of iTBS
Time frame: baseline to week 8
Change in Fall assessment test after 8 courses
Time frame: baseline to week 8
Change in Tinetti's Mobility Index after 8 courses of iTBS
Time frame: baseline to week 8
Change in new freezing of gait questionnaire (FOG-Q) after 8 courses
Time frame: baseline to week 8
Change in Patients' Global Impressions of Change (PGIC) Scale after 8 courses of iTBS
Time frame: baseline to week 8
Change in Clinical Global Impressions (CGI) after 8 courses of iTBS
Time frame: baseline to week 8
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 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.
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 real iTBS in people with Parkinson's Disease and Parkinson's Disease With Freezing of Gait, run by China Medical University Hospital at 1 site in Taiwan.
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 1 inclusion and 2 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: withdrawn, as of the sponsor's last update on 8 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 Taiwan. 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. Some participants in this study may receive a placebo. 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 was withdrawn before enrolling participants, so there are no results.
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?
Change in Laboratory gait analysis after 8 courses of iTBS (time frame: baseline to week 8). 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 8 Aug 2014.