Parkinson's Disease With Freezing of GaitNCT03127475
Neurophysiological Dissection and Intervention of Freezing of Gait in Parkinson's Disease
A study testing Transcranial direct current stimulation in people with Parkinson's Disease With Freezing of Gait, run by China Medical University Hospital at 1 site in Taiwan.
Trial summary
Different conditions of gait ignition freezing, spontaneous freezing during walking and turning freezing on encountering obstacle will be investigated in fMRI study to examine whether different regions of brain will be involved under different conditions of freezing. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Parkinson's Disease With Freezing of Gait
- What is being tested?
- Transcranial direct current stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2016to 31 Oct 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The diagnosis of freezing of gait will be made by the following criteria:
- Without video:Is there any feeling that your feet are transiently glued to the floor while trying to initiate walking, making a turn or when walking through narrow spaces or in crowded places? (Sometimes it can be accompanied with trembling of the legs and small shuffling steps.)
- Additional instructions with video:We will watch a short video together to see the many ways in which freezing can occur. Also, look carefully for how long these episodes last, as you can expect some questions on this later.
- Patient is diagnosed to have freezing of gait if "I have experienced such a feeling or episode over the past month" was answered.
Who cannot join
- Impairment of cognition that leads unable to fully cooperate with the oral commands during examinations.
- Moderate to severe medical disorders such as functional III or above congestive heart failure, or cancer with distant metastasis etc.
- Hoehn and Yahr stage 5.
Trial locations and contacts
1 site in 1 country.
About this study
Different conditions of gait ignition freezing, spontaneous freezing during walking and turning freezing on encountering obstacle will be investigated in fMRI study to examine whether different regions of brain will be involved under different conditions of freezing. We hypothesize that anterior cortical regions will engage in gait ignition failure, deep locomotion regions will be responsible for spontaneous freezing and schema regions will be involved in the generation of turning freezing on seeing the barrier. In the third part of the project, we will deliver a 5-day session of transcranial direct current stimulation (tDCS) to the motor cortex of the FOG patients to examine whether the intervention will benefit the patients. Based on the signal source findings, we will investigate whether the possible tDCS beneficial effect will be different or similar in patients with different electric sources. In addition, how long the possible beneficial effect of tDCS can be consolidated after the 5-day course of stimulation is crucial and requires to be elucidated under the research project. We aim to peep the myth of FOG in PD by the multi-modality approach and hope the study will benefit the long suffering patients.
- Being tested
- Transcranial direct current stimulation
- Keywords
- Parkinson's disease, freezing of gait, electrophysiology, magnetic resonance image, direct current 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.
Transcranial direct current stimulationDevice
A consecutive 5-days course of tDCS will be delivered. In treatment group, true stimulation will be administrated and sham stimulation will be delivered in control group.
| Study group | Role | What they receive |
|---|---|---|
| real tDCS | Experimental | Device: Transcranial direct current stimulation In tDCS,the anodal pad was tapped over the primary motor cortex and the cathode pad was adhered of the contralateral frontal region. A constant current of 2.0 mA will be apply for up to 20 min, with a linear fade in /fade out of 10 s in anodal and cathodal conditions resulting in a current density of 0.8A/M2 which is 177 times below the lesion effect of tDCS in the rats study(142.9A/m2) Receives: Device: Transcranial direct current stimulation |
| sham tDCS | Sham comparator | Device: Sham tDCS Sham stimulation will be 30s stimulation with ramp up and ramp off for 10s at 2.0 mA. Receives: Device: Transcranial direct current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in laboratory gait analysis after the tDCS session
Variables in gait analysis:1.Gait initiation, 2.Level walking, 3.Turning, 4.Gait termination
Measured: baseline to week 4
Secondary outcomes (1)
Change in Unified Parkinson's Disease Rating Scale (UPDRS) after the tDCS session
Measured: baseline to week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2017
- Study start1 Aug 2016
- Primary completion31 Jul 2017
- Study completion31 Oct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's Disease With Freezing of GaitStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Science and Technology, Taiwan
- Responsible party
- Principal investigator, Chon-Haw Tsai, China Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03127475
- Sponsor's protocol ID
- CMUH105-REC1-004
- Status last verified
- Sep 2018
- First submitted
- 18 Apr 2017
- Last updated
- 18 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurophysiological Dissection and Intervention of Freezing of Gait in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT03127475
- Acronym / sponsor ID
- CMUH105-REC1-004
- Keywords
- Parkinson's disease, freezing of gait, electrophysiology, magnetic resonance image, direct current stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Collaborators
- Ministry of Science and Technology, Taiwan
- Study start
- 1 Aug 2016 (actual)
- Primary completion
- 31 Jul 2017 (actual)
- Study completion
- 31 Oct 2018 (estimated)
- First posted
- 25 Apr 2017 (actual)
- 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.
Different conditions of gait ignition freezing, spontaneous freezing during walking and turning freezing on encountering obstacle will be investigated in fMRI study to examine whether different regions of brain will be involved under different conditions of freezing. We hypothesize that anterior cortical regions will engage in gait ignition failure, deep locomotion regions will be responsible for spontaneous freezing and schema regions will be involved in the generation of turning freezing on seeing the barrier. In the third part of the project, we will deliver a 5-day session of transcranial direct current stimulation (tDCS) to the motor cortex of the FOG patients to examine whether the intervention will benefit the patients. Based on the signal source findings, we will investigate whether the possible tDCS beneficial effect will be different or similar in patients with different electric sources. In addition, how long the possible beneficial effect of tDCS can be consolidated after the 5-day course of stimulation is crucial and requires to be elucidated under the research project. We aim to peep the myth of FOG in PD by the multi-modality approach and hope the study will benefit the long suffering patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| real tDCS | Experimental | Device: Transcranial direct current stimulationDevice: Transcranial direct current stimulation In tDCS,the anodal pad was tapped over the primary motor cortex and the cathode pad was adhered of the contralateral frontal region. A constant current of 2.0 mA will be apply for up to 20 min, with a linear fade in /fade out of 10 s in anodal and cathodal conditions resulting in a current density of 0.8A/M2 which is 177 times below the lesion effect of tDCS in the rats study(142.9A/m2) |
| sham tDCS | Sham comparator | Device: Transcranial direct current stimulationDevice: Sham tDCS Sham stimulation will be 30s stimulation with ramp up and ramp off for 10s at 2.0 mA. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Without video:Is there any feeling that your feet are transiently glued to the floor while trying to initiate walking, making a turn or when walking through narrow spaces or in crowded places? (Sometimes it can be accompanied with trembling of the legs and small shuffling steps.)
- Additional instructions with video:We will watch a short video together to see the many ways in which freezing can occur. Also, look carefully for how long these episodes last, as you can expect some questions on this later.
- Patient is diagnosed to have freezing of gait if "I have experienced such a feeling or episode over the past month" was answered.
Key exclusion criteria (3 listed)
- Impairment of cognition that leads unable to fully cooperate with the oral commands during examinations.
- Moderate to severe medical disorders such as functional III or above congestive heart failure, or cancer with distant metastasis etc.
- Hoehn and Yahr stage 5.
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 |
|---|---|---|
| Transcranial direct current stimulationA consecutive 5-days course of tDCS will be delivered. In treatment group, true stimulation will be administrated and sham stimulation will be delivered in control group. | Device | real tDCS, sham tDCS |
Primary outcome
Change in laboratory gait analysis after the tDCS session
Time frame: baseline to week 4
Variables in gait analysis:1.Gait initiation, 2.Level walking, 3.Turning, 4.Gait termination
1 secondary outcome
Change in Unified Parkinson's Disease Rating Scale (UPDRS) after the tDCS session
Time frame: baseline to week 4
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2018.
- Individual participant dataSharing planned: Undecided
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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 Transcranial direct current stimulation in people with 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 4 inclusion and 3 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 18 Sep 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 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?
Results are not available in the source record.
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 the tDCS session (time frame: baseline to week 4). 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 18 Sep 2018.