UPDRSNCT01016743
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 UPDRS, run by Sheba Medical Center.
Trial summary
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) and to establish its safety in this population. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- UPDRS
- What is being tested?
- repetitive transcranial stimulation (r-TMS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Nov 2009to Jul 2010
- 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 80 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 dementia or any 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).
About this study
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) and to establish its safety in this population. The investigators anticipate that reaching deeper brain layers and larger volume of activation with the novel H-coil may induce significantly better therapeutic effects in patients with PD and will pave the way for establishing a novel and effective treatment for this disorder.
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:
- They have concomitant epilepsy, a history of seizure or heat convulsion or history of epilepsy in first degree relative.
- Are on neuroleptics.
- Have dementia or any unstable medical disorder.
- Have a history or current unstable hypertension.
- Have a history of head injury or neurosurgical interventions.
- Have a history of any metal in the head (outside the mouth).
- Have a known history of any metallic particles in the eye, implanted cardiac pacemaker, implanted neurostimulators, surgical clips (above the shoulder line) or any medical pumps.
Patients will be randomized into two groups: The first group of patients will receive an active unilateral stimulation over the motor cortex contralateral to the more affected body side (1Hz stimulation 110% of the MT for 15 minutes). Patients in the second group will receive a similar rTMS stimulation pattern over the motor cortex and over the prefrontal cortex (10Hz stimulation 100% of the MT, 2 seconds each train, 20 seconds between trains, for 15 minutes).
The following outcome measures will be taken prior to the treatment (screening visit), and at day 1, 10, 30 and 60 Evaluation will be while subjects 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.
8.Have a history of migraine or frequent or severe headaches. 9.Have a history of hearing loss. 10.Has a of cochlear implants 11.Have a history of drug abuse or alcoholism. 12.Is pregnant or not using a reliable method of birth control. 13.Is participating in current clinical study or clinical study within 30 days prior to this study.
- Conditions
- UPDRS
- Being tested
- repetitive transcranial stimulation (r-TMS)
- Keywords
- parkinson, rTMS
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
Patients will be randomized into two groups: The first group of patients will receive an active unilateral stimulation over the motor cortex contralateral to the more affected body side (1Hz stimulation 110% of the MT for 15 minutes). Patients in the second group will receive a similar rTMS stimulation pattern over the motor cortex and over the prefrontal cortex (10Hz stimulation 100% of the MT, 2 seconds each train, 20 seconds between trains, for 15 minutes).
| Study group | Role | What they receive |
|---|---|---|
| Active repetitive transcranial Stimulation | Active comparator | Patients will be randomized into two groups: The first group of patients will receive an active unilateral stimulation over the motor cortex contralateral to the more affected body side (1Hz stimulation 110% of the MT for 15 minutes). Patients in the second group will receive a similar rTMS stimulation pattern over the motor cortex and over the prefrontal cortex (10Hz stimulation 100% of the MT, 2 seconds each train, 20 seconds between trains, for 15 minutes). Receives: Device: repetitive transcranial stimulation (r-TMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unified Parkinson's Disease Rating Scale (UPDRS )
Measured: 1 year
Secondary outcomes (2)
CGIS,Pegboard test.Tapping test,Up&Go test,AIMS,BDI,MMSE,Word fluencyFAB
Measured: 1 year
UPDRS
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 posted19 Nov 2009 (estimated)
- Study startNov 2009
- Primary completionJul 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UPDRSStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01016743
- Sponsor's protocol ID
- SHEBA-09-7279-OC-CTIL
- Status last verified
- Nov 2009
- First submitted
- 18 Nov 2009
- Last updated
- 19 Nov 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- NCT01016743
- Acronym / sponsor ID
- SHEBA-09-7279-OC-CTIL
- Conditions
- UPDRS
- Keywords
- parkinson, rTMS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Nov 2009
- Primary completion
- Jul 2010 (estimated)
- First posted
- 19 Nov 2009 (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.
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) and to establish its safety in this population. The investigators anticipate that reaching deeper brain layers and larger volume of activation with the novel H-coil may induce significantly better therapeutic effects in patients with PD and will pave the way for establishing a novel and effective treatment for this disorder.
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:
- They have concomitant epilepsy, a history of seizure or heat convulsion or history of epilepsy in first degree relative.
- Are on neuroleptics.
- Have dementia or any unstable medical disorder.
- Have a history or current unstable hypertension.
- Have a history of head injury or neurosurgical interventions.
- Have a history of any metal in the head (outside the mouth).
- Have a known history of any metallic particles in the eye, implanted cardiac pacemaker, implanted neurostimulators, surgical clips (above the shoulder line) or any medical pumps.
Patients will be randomized into two groups: The first group of patients will receive an active unilateral stimulation over the motor cortex contralateral to the more affected body side (1Hz stimulation 110% of the MT for 15 minutes). Patients in the second group will receive a similar rTMS stimulation pattern over the motor cortex and over the prefrontal cortex (10Hz stimulation 100% of the MT, 2 seconds each train, 20 seconds between trains, for 15 minutes).
The following outcome measures will be taken prior to the treatment (screening visit), and at day 1, 10, 30 and 60 Evaluation will be while subjects 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.
8.Have a history of migraine or frequent or severe headaches. 9.Have a history of hearing loss. 10.Has a of cochlear implants 11.Have a history of drug abuse or alcoholism. 12.Is pregnant or not using a reliable method of birth control. 13.Is participating in current clinical study or clinical study within 30 days prior to this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active repetitive transcranial Stimulation | Active comparator | Device: repetitive transcranial stimulation (r-TMS)Patients will be randomized into two groups: The first group of patients will receive an active unilateral stimulation over the motor cortex contralateral to the more affected body side (1Hz stimulation 110% of the MT for 15 minutes). Patients in the second group will receive a similar rTMS stimulation pattern over the motor cortex and over the prefrontal cortex (10Hz stimulation 100% of the MT, 2 seconds each train, 20 seconds between trains, for 15 minutes). |
Who may qualify
- Ages
- 40 to 80 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 (6 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 dementia or any 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)Patients will be randomized into two groups: The first group of patients will receive an active unilateral stimulation over the motor cortex contralateral to the more affected body side (1Hz stimulation 110% of the MT for 15 minutes). Patients in the second group will receive a similar rTMS stimulation pattern over the motor cortex and over the prefrontal cortex (10Hz stimulation 100% of the MT, 2 seconds each train, 20 seconds between trains, for 15 minutes). | Device | Active repetitive transcranial Stimulation |
Primary outcome
Unified Parkinson's Disease Rating Scale (UPDRS )
Time frame: 1 year
2 secondary outcomes
CGIS,Pegboard test.Tapping test,Up&Go test,AIMS,BDI,MMSE,Word fluencyFAB
Time frame: 1 year
UPDRS
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 19 Nov 2009.
Related trials for UPDRS
RecruitingPhase 1
A Phase I Study in Healthy Volunteers and Parkinson's Disease (PD) Patients.
Parkinson's Disease (PD), Mild to Moderate Parkinson's Disease
Not yet recruitingPhase 4
Metformin in Parkinson's Disease: Safety and Efficacy
Parkinsons Disease (PD)
RecruitingObservational study
A US Study That Observes How Parkinson's Disease Changes Over Time in Patients Who Still Have Movement Symptoms Despite Taking Parkinson's Medications
Parkinson's Disease
RecruitingObservational study
Artificial Intelligence-assisted MDS-UPDRS Assessment for Parkinson's Disease
Parkinson Disease
Enrolling by invitation
Cerebellar Transcranial Direct Current Stimulation in Parkinson's Disease
PARKINSON DISEASE (Disorder)
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.
Questions about this trial
What is this clinical trial studying?
A study testing repetitive transcranial stimulation (r-TMS) in people with UPDRS, run by Sheba Medical Center.
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 6 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 19 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Unified Parkinson's Disease Rating Scale (UPDRS ) (time frame: 1 year). 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 19 Nov 2009.