Essential TremorNCT01940406
The Essential Tremor (ET) and Parkinson Disease (PD) Tremor Acute Stimulation Study
A study testing Stimulation procedure in people with Essential Tremor and Parkinson Disease, run by BlueWind Medical at 1 site in Israel.
Trial summary
The current study is designed to test the hypothesis that targeted electrical stimulation will result in upper limb tremor reduction in ET and PD patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Essential Tremor, Parkinson Disease
- What is being tested?
- Stimulation procedure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteIsrael
- Study dates
- Oct 2013to Dec 2013
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to Sign written informed consent in Hebrew.
- Patient agrees to attend all treatment procedures and follow-up evaluations and is willing and able to comply with all study requirements.
- Patient with a clinical diagnosis of idiopathic PD, or ET for more than 3 years.
- Significant tremor for at least one upper limb causing distress or disability.
- Patient should be stable on anti-Parkinson's disease or anti-tremor medication for at least one month prior to study enrollment.
Who cannot join
- Previous participation in another study with any investigational drug or device within the past 90 days.
- Any active implant (cardiac or other).
- Current pregnancy or attempting to get pregnant (female patient).
- Patient has any major illness or medical condition that in the opinion of the physician would interfere with participation in the study.
- Patient with other significant neurological or psychiatric disease other than Parkinson Disease or Essential Tremor.
- Patient has any other condition expect for PD and ET that induce tremor.
Show all 12Show fewer
- Patient is treated with drug that may induce tremor.
- Patient abuses drugs or alcohol.
- Any previous thalamotomy, pallidotomy or patient who has undergone a DBS procedure.
- Any anticipated need for surgery during the study.
- Any malignancy in the past 2 years.
- Patient has confirmation of diagnosis of a terminal illness associated with survival <12 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The ET and PD Tremor Study - Rainbow Medical Acute Stimulation Evaluation for Tremor Reduction
The current study is designed to test the hypothesis that targeted electrical stimulation will result in upper limb tremor reduction in ET and PD patients.
Read the detailed description
This study will evaluate the effect of Rainbow Medical's stimulation procedure methodology that will be applied temporarily to patients suffering of tremor.
This will be evaluated by assessment of reduction of tremor using accelerometer measurements, patient tremor evaluation diary, tremor rating scale, and the Unified Parkinson's Disease Rating Scale (UPRDS) part III.In addition,tasks for patient with tremor will be conducted before during and after the treatment. The above measurements will provide data on the stimulation procedure effect as compared to baseline.
- Conditions
- Essential Tremor, Parkinson Disease
- Being tested
- Stimulation procedure
- Keywords
- Essential Tremor, Parkinson Disease, Electrical Stimulation, Tremor
- Medical subject headings
- Essential Tremor, Parkinson Disease, Tremor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stimulation procedureProcedure or surgery
Device
| Study group | Role | What they receive |
|---|---|---|
| Stimulation procedure | Experimental | Stimulation procedure Receives: Procedure: Stimulation procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
The severe adverse events rate within the procedure
Measured: participants will be followed for the duration of hospital stay, an expected average of 3 weeks
Secondary outcomes (1)
Improvement in tremor symptoms during the procedure
Improvement after treatment in ET and PD tremor symptoms in comparison to baseline, as measured by change in:
- UPDRS part III scale
- Clinical Tremor Rating Scale
- Accelerometer values
- Patient tremor evaluation diary
Measured: participants will be followed for the duration of hospital stay, an expected average of 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2013 (estimated)
- Study startOct 2013
- Primary completionNov 2013 (estimated)
- Study completionDec 2013 (estimated)
Why it stopped: Internal desicions
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Essential TremorStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- BlueWind Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shirley Giorini Silfen, PhD, Study director, BlueWind Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01940406
- Sponsor's protocol ID
- CP-01-001
- Status last verified
- Feb 2018
- First submitted
- 16 Jul 2013
- Last updated
- 23 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The ET and PD Tremor Study - Rainbow Medical Acute Stimulation Evaluation for Tremor Reduction
- ClinicalTrials.gov ID
- NCT01940406
- Acronym / sponsor ID
- CP-01-001
- Conditions
- Essential Tremor, Parkinson Disease
- Keywords
- Essential Tremor, Parkinson Disease, Electrical Stimulation, Tremor
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Internal desicions
- Enrolment
- 0 participants (actual)
- Lead sponsor
- BlueWind MedicalIndustry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- Nov 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 12 Sep 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 current study is designed to test the hypothesis that targeted electrical stimulation will result in upper limb tremor reduction in ET and PD patients.
Detailed description
This study will evaluate the effect of Rainbow Medical's stimulation procedure methodology that will be applied temporarily to patients suffering of tremor.
This will be evaluated by assessment of reduction of tremor using accelerometer measurements, patient tremor evaluation diary, tremor rating scale, and the Unified Parkinson's Disease Rating Scale (UPRDS) part III.In addition,tasks for patient with tremor will be conducted before during and after the treatment. The above measurements will provide data on the stimulation procedure effect as compared to baseline.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stimulation procedure | Experimental | Procedure: Stimulation procedureStimulation procedure |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Able to Sign written informed consent in Hebrew.
- Patient agrees to attend all treatment procedures and follow-up evaluations and is willing and able to comply with all study requirements.
- Patient with a clinical diagnosis of idiopathic PD, or ET for more than 3 years.
- Significant tremor for at least one upper limb causing distress or disability.
- Patient should be stable on anti-Parkinson's disease or anti-tremor medication for at least one month prior to study enrollment.
Key exclusion criteria (12 listed)
- Previous participation in another study with any investigational drug or device within the past 90 days.
- Any active implant (cardiac or other).
- Current pregnancy or attempting to get pregnant (female patient).
- Patient has any major illness or medical condition that in the opinion of the physician would interfere with participation in the study.
- Patient with other significant neurological or psychiatric disease other than Parkinson Disease or Essential Tremor.
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 |
|---|---|---|
| Stimulation procedureDevice | Procedure or surgery | Stimulation procedure |
Primary outcome
The severe adverse events rate within the procedure
Time frame: participants will be followed for the duration of hospital stay, an expected average of 3 weeks
1 secondary outcome
Improvement in tremor symptoms during the procedure
Time frame: participants will be followed for the duration of hospital stay, an expected average of 3 weeks
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 23 Feb 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.
Shirley Giorini Silfen, PhD study director
BlueWind Medical
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stimulation procedure in people with Essential Tremor and Parkinson Disease, run by BlueWind Medical 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 5 inclusion and 12 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 23 Feb 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 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?
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?
The severe adverse events rate within the procedure (time frame: participants will be followed for the duration of hospital stay, an expected average of 3 weeks). 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 23 Feb 2018.