Asymmetric Parkinson's DiseaseNCT01367782
A Double Blind Sham-controled Study to Evaluate the Influence of Low Frequency Repetitive Transcranial Stimulation (r-TMS) on Motor and Cognitive Measurements in Patients With Asymmetric Parkinson's Disease
A study testing repetitive transcranial stimulation (r-TMS) in people with Asymmetric Parkinson's Disease, run by Sheba Medical Center at 1 site in Israel.
Trial summary
The purpose of this study is to test the effects of low frequency deep rTMS using the novel H-coil on the motor, affective and cognitive deficits in patients with asymmetric Parkinson's disease (PD), to establish its safety in this population and to test effects of maintenance treatments. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Asymmetric Parkinson's Disease
- What is being tested?
- repetitive transcranial stimulation (r-TMS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 1 siteIsrael
- Study dates
- May 2011to Dec 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 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- PD patients with asymmetric disease aged 40 years or older, diagnosed as idiopathic PD according to the UK Brain Bank criteria, with Hoehn \& Yahr stages II - IV while "off".
- Participants on antidepressants should be at least 2 months on stable therapy.
Who cannot join
- Patients who have concomitant epilepsy, a history of seizure or heat convulsion or history of epilepsy in first degree relative.
- Patients on neuroleptics.
- Patients with unstable medical disorder.
- History or current unstable hypertension.
- History of head injury or neurosurgical interventions.
- History of any metal in the head (outside the mouth).
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- Known history of any metallic particles in the eye, implanted cardiac pacemaker, implanted neurostimulators, surgical clips (above the shoulder line) or any medical pumps.
- History of migraine or frequent or severe headaches.
- Current hearing loss.
- The presence of cochlear implants
- Current drug abuse or alcoholism.
- Pregnancy or not using a reliable method of birth control.
- Participation in current clinical study or clinical study within 30 days prior to this study.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Sheba Medical Center
Tel HaShomer, 52621
Oren Cohen, MD, Oren.Cohen@sheba.health.gov.il
About this study
The purpose of this study is to test the effects of low frequency deep rTMS using the novel H-coil on the motor, affective and cognitive deficits in patients with asymmetric Parkinson's disease (PD), to establish its safety in this population and to test effects of maintenance treatments.
Read the detailed description
PD patients with asymmetric disease aged 40 years or older, diagnosed as idiopathic PD according to the UK Brain Bank criteria, with Hoehn \& Yahr stages II - IV while "off" will be recruited. Participants on antidepressants should be at least 2 months on stable therapy.
Patient will be excluded if:
- Patients who have concomitant epilepsy, a history of seizure or heat convulsion or history of epilepsy in first degree relative.
- Patients on neuroleptics.
- Patients with unstable medical disorder.
- History or current unstable hypertension.
- History of head injury or neurosurgical interventions.
- History of any metal in the head (outside the mouth).
- Known history of any metallic particles in the eye, implanted cardiac pacemaker, implanted neurostimulators, surgical clips (above the shoulder line) or any medical pumps.
- History of migraine or frequent or severe headaches.
- Current hearing loss.
- The presence of cochlear implants
- Current drug abuse or alcoholism.
- Pregnancy or not using a reliable method of birth control.
- Participation in current clinical study or clinical study within 30 days prior to this study.
Patients will be to randomized to an active rTMS arm or to a sham stimulation arm. Each patient will be given 12 stimulation sessions, over a period of 4 weeks, and then a maintenance phase consisting of 8 stimulation sessions for the first 4 weeks and additional 4 stimulation sessions during the following 4 weeks.
Active treatment with the H-coil will include stimulation over the motor cortex (1 Hz stimulation 110% of the motor threshold for 15 minutes) and over the prefrontal cortex (10Hz stimulation 100% of the motor threshold, 2 seconds each train, 20 seconds between trains, for 15 minutes). The control arm group will receive sham stimulations in identical treatment and maintenance schedules. Patients from the sham group who will complete the study will be given the opportunity to receive 12 sessions of real r-TMS treatment over 4 weeks as the treatment group.
The following outcome measures will be taken prior to the treatment (screening visit), and at day 1, 10, 30, 60 and 90. Evaluation will be while subjects are both at "on" and "off".
Motor:
- Unified Parkinson's Disease Rating Scale (UPDRS )
- Clinical Global Impression of Severity (CGIS)
- Pegboard test.
- Tapping test
- Up \& Go test
- Abnormal Involuntary Movement Scale (AIMS) Mood and affect
- Beck Depression Inventory (BDI) Cognition
- Mini mental State examination (MMSE)
- Digit forward and backward tests.
- Word fluency.
- Frontal Assessment Battery (FAB)
Side effects will be closely monitored by the researchers and will be promptly reported to the IRB.
- Conditions
- Asymmetric Parkinson's Disease
- Being tested
- repetitive transcranial stimulation (r-TMS)
- Keywords
- UPDRS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
repetitive transcranial stimulation (r-TMS)Device
Active treatment with the H-coil will include stimulation over the motor cortex (1 Hz stimulation 110% of the motor threshold for 15 minutes) and over the prefrontal cortex (10Hz stimulation 100% of the motor threshold, 2 seconds each train, 20 seconds between trains, for 15 minutes).
repetitive transcranial stimulation (r-TMS)Device
Sham treatment with the H-coil will include sham stimulation over the motor cortex and over the prefrontal cortex.
| Study group | Role | What they receive |
|---|---|---|
| Active repetitive Transcranial Stimulation | Active comparator | Each patient will be given 12 stimulation sessions, over a period of 4 weeks, and then a maintenance phase consisting of 8 stimulation sessions for the first 4 weeks and additional 4 stimulation sessions during the following 4 weeks. Receives: Device: repetitive transcranial stimulation (r-TMS) |
| Sham Stimulation | Sham comparator | The control arm group will receive sham stimulations in identical treatment and maintenance schedules. Receives: Device: repetitive transcranial stimulation (r-TMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease in Unified Parkinson's Disease Rating Scale (UPDRS) score
A decrease in the total UPDRS score in general and in the Motor UPDRS (part 3) score.
Measured: 3 months
Secondary outcomes (7)
CGIS
Rater and patient's opinion on the change in thier PD due to the TMS treatment
Measured: 3 months
Decrease in time in Pegboard test
Measured: 3 months
Increase in Tapping test
Measured: 3 months
Decrease in Time Up&Go test
Patient has to get up from a chair, walk 3 meters, turn around and return to sit on the chair.
Measured: 3 months
Increase in Word fluency
Number of words the patient can think of that start with a certian letter or belong to a certian catagory, in one minute.
Measured: 3 months
Increase in Digits Forward & Backwards test
Measured: 3 months
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2011 (estimated)
- Study startMay 2011
- Primary completionDec 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asymmetric Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 51 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Collaborators
- Brainsway
- Responsible party
- Principal investigator, Dr. Oren Cohen, Sheba Medical Center
- Investigators
- Oren Cohen, MD, Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01367782
- Sponsor's protocol ID
- SHEBA-11-8470-OC-CTIL
- Status last verified
- Sep 2014
- First submitted
- 30 May 2011
- Last updated
- 11 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind Sham-controled Study to Evaluate the Influence of Low Frequency Repetitive Transcranial Stimulation (r-TMS) on Motor and Cognitive Measurements in Patients With Asymmetric Parkinson's Disease
- ClinicalTrials.gov ID
- NCT01367782
- Acronym / sponsor ID
- SHEBA-11-8470-OC-CTIL
- Conditions
- Asymmetric Parkinson's Disease
- Keywords
- UPDRS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Collaborators
- Brainsway
- Study start
- May 2011
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 7 Jun 2011 (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 purpose of this study is to test the effects of low frequency deep rTMS using the novel H-coil on the motor, affective and cognitive deficits in patients with asymmetric Parkinson's disease (PD), to establish its safety in this population and to test effects of maintenance treatments.
Detailed description
PD patients with asymmetric disease aged 40 years or older, diagnosed as idiopathic PD according to the UK Brain Bank criteria, with Hoehn \& Yahr stages II - IV while "off" will be recruited. Participants on antidepressants should be at least 2 months on stable therapy.
Patient will be excluded if:
- Patients who have concomitant epilepsy, a history of seizure or heat convulsion or history of epilepsy in first degree relative.
- Patients on neuroleptics.
- Patients with unstable medical disorder.
- History or current unstable hypertension.
- History of head injury or neurosurgical interventions.
- History of any metal in the head (outside the mouth).
- Known history of any metallic particles in the eye, implanted cardiac pacemaker, implanted neurostimulators, surgical clips (above the shoulder line) or any medical pumps.
- History of migraine or frequent or severe headaches.
- Current hearing loss.
- The presence of cochlear implants
- Current drug abuse or alcoholism.
- Pregnancy or not using a reliable method of birth control.
- Participation in current clinical study or clinical study within 30 days prior to this study.
Patients will be to randomized to an active rTMS arm or to a sham stimulation arm. Each patient will be given 12 stimulation sessions, over a period of 4 weeks, and then a maintenance phase consisting of 8 stimulation sessions for the first 4 weeks and additional 4 stimulation sessions during the following 4 weeks.
Active treatment with the H-coil will include stimulation over the motor cortex (1 Hz stimulation 110% of the motor threshold for 15 minutes) and over the prefrontal cortex (10Hz stimulation 100% of the motor threshold, 2 seconds each train, 20 seconds between trains, for 15 minutes). The control arm group will receive sham stimulations in identical treatment and maintenance schedules. Patients from the sham group who will complete the study will be given the opportunity to receive 12 sessions of real r-TMS treatment over 4 weeks as the treatment group.
The following outcome measures will be taken prior to the treatment (screening visit), and at day 1, 10, 30, 60 and 90. Evaluation will be while subjects are both at "on" and "off".
Motor:
- Unified Parkinson's Disease Rating Scale (UPDRS )
- Clinical Global Impression of Severity (CGIS)
- Pegboard test.
- Tapping test
- Up \& Go test
- Abnormal Involuntary Movement Scale (AIMS) Mood and affect
- Beck Depression Inventory (BDI) Cognition
- Mini mental State examination (MMSE)
- Digit forward and backward tests.
- Word fluency.
- Frontal Assessment Battery (FAB)
Side effects will be closely monitored by the researchers and will be promptly reported to the IRB.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active repetitive Transcranial Stimulation | Active comparator | Device: repetitive transcranial stimulation (r-TMS)Each patient will be given 12 stimulation sessions, over a period of 4 weeks, and then a maintenance phase consisting of 8 stimulation sessions for the first 4 weeks and additional 4 stimulation sessions during the following 4 weeks. |
| Sham Stimulation | Sham comparator | Device: repetitive transcranial stimulation (r-TMS)The control arm group will receive sham stimulations in identical treatment and maintenance schedules. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- PD patients with asymmetric disease aged 40 years or older, diagnosed as idiopathic PD according to the UK Brain Bank criteria, with Hoehn \& Yahr stages II - IV while "off".
- Participants on antidepressants should be at least 2 months on stable therapy.
Key exclusion criteria (13 listed)
- Patients who have concomitant epilepsy, a history of seizure or heat convulsion or history of epilepsy in first degree relative.
- Patients on neuroleptics.
- Patients with unstable medical disorder.
- History or current unstable hypertension.
- History of head injury or neurosurgical interventions.
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 |
|---|---|---|
| repetitive transcranial stimulation (r-TMS)Active treatment with the H-coil will include stimulation over the motor cortex (1 Hz stimulation 110% of the motor threshold for 15 minutes) and over the prefrontal cortex (10Hz stimulation 100% of the motor threshold, 2 seconds each train, 20 seconds between trains, for 15 minutes). | Device | Active repetitive Transcranial Stimulation |
| repetitive transcranial stimulation (r-TMS)Sham treatment with the H-coil will include sham stimulation over the motor cortex and over the prefrontal cortex. | Device | Sham Stimulation |
Primary outcome
Decrease in Unified Parkinson's Disease Rating Scale (UPDRS) score
Time frame: 3 months
A decrease in the total UPDRS score in general and in the Motor UPDRS (part 3) score.
7 secondary outcomes
CGIS
Time frame: 3 months
Decrease in time in Pegboard test
Time frame: 3 months
Increase in Tapping test
Time frame: 3 months
Decrease in Time Up&Go test
Time frame: 3 months
Increase in Word fluency
Time frame: 3 months
Increase in Digits Forward & Backwards test
Time frame: 3 months
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2014.
Related trials for Asymmetric Parkinson's Disease
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Parkinson Disease
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.
Oren Cohen, MD principal investigator
Sheba 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 repetitive transcranial stimulation (r-TMS) in people with Asymmetric Parkinson's Disease, run by Sheba 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 2 inclusion and 13 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 11 Sep 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. 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?
Contact Oren Cohen, MD (+972-3-5305296, Oren.Cohen@sheba.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decrease in Unified Parkinson's Disease Rating Scale (UPDRS) score (time frame: 3 months). 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 11 Sep 2014.