Parkinson's DiseaseNCT01037686
The Effect of Electrode Implantation for Deep Brain Stimulation (DBS) on Brain Function Using Single Photon Emission Computed Tomography (SPECT) With Technetium-99m-ethyl Cysteinatedimer (Tc-ECD)
A study testing Injection of 15mCi of Tc-ECD and scanning by SPECT camera, Semantic verbal fluency task performance and Turning off the stimulator in people with Parkinson's Disease and Deep Brain Stimulation, run by Sheba Medical Center at 1 site in Israel.
Trial summary
The goal of this study is to explore the effect of subthalamic nucleus (STN)-DBS surgery and stimulation in PD (Parkinson's disease) patients on regional cerebral blood (CBF) flow during cognitive task performance or at rest. Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson's Disease, Deep Brain Stimulation
- What is being tested?
- Injection of 15mCi of Tc-ECD and scanning by SPECT camera, Semantic verbal fluency task performance and Turning off the stimulator
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteIsrael
- Study dates
- Feb 2006to Oct 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Progressive idiopathic PD
- For control group - age-matched to study groups
Who cannot join
- Progressive dementia or other psychiatric disorders
- Other neurological conditions
- Other physical disease
- Intolerance of "off stimulation" state
- Involuntary head motions
- Hearing deficits
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Movement Disorders Clinic, Sheba Medical Center
Ramat Gan, 52621
Sharon Hassin, MD, 97235305791, sharon.hassin@sheba.health.gov.il
Yafit Kuttner, B.Sc, 97235304753, yafitkuttner@yahoo.com
About this study
Official title: Exploring the Effect of Electrode Implantation for DBS on Brain Function During Rest and During Semantic Verbal Fluency Task Using SPECT With Tc-ECD
The goal of this study is to explore the effect of subthalamic nucleus (STN)-DBS surgery and stimulation in PD (Parkinson's disease) patients on regional cerebral blood (CBF) flow during cognitive task performance or at rest.
Read the detailed description
In this study subjects undergo SPECT scans for CBF mapping. PD patients before the surgery and healthy controls undergo two scans. PD patients after the surgery undergo four scans. PD patients who undergo two scans before the surgery, undergo only two scans after the surgery.
Uptake of Tc-ECD, a CBF radiotracer, is done in the following conditions:
- For PD patients before the surgery - during the performance of the semantic verbal fluency task or at rest (total of 2 scans).
- For PD patients after the surgery- during the performance of the semantic verbal fluency task or at rest, either at on-stimulation or off-stimulation condition (total of 4 scans). The stimulator is turned off by the neurologist for 10 min.
- PD patients before and after the surgery- during performance of the semantic verbal fluency task or at rest before the surgery and during performance of the semantic verbal fluency task or at rest after the surgery only at off-stimulation condition (Total of 4 scans).
- Healthy controls - during the performance of the semantic verbal fluency task or at rest (total of 2 scans).
Following the Tc-ECD injection, the subjects are scanned by Irix SPECT camera for 15min.
Scans are analyzed and the regional CBF is measured using imaging software. Statistical analysis is done to discover the effect of the surgery, stimulation and the disease on blood flow at rest and during task performance. In addition, differences between groups in number of words produced during the task are also statistically analyzed.
- Conditions
- Parkinson's Disease, Deep Brain Stimulation
- Being tested
- Injection of 15mCi of Tc-ECD and scanning by SPECT camera, Semantic verbal fluency task performance, Turning off the stimulator
- Keywords
- PD, DBS
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Injection of 15mCi of Tc-ECD and scanning by SPECT cameraRadiation
All subjects (PD patients with or without DBS and healthy controls) will be injected with 15mCi of Tc-ECD and afterwards will be scanned by an Irix SPECT camera.
Semantic verbal fluency task performanceBehavioural
All Subjects (PD patients with or without DBS and healthy controls) before one of the two scans will perform the semantic verbal fluency task during the Tc-ECD uptake for 9 minutes. Before the other scan subjects will be at rest.
Turning off the stimulatorDevice
For PD patients treated with DBS, the neurologist will turn off the stimulator after the injection of Tc-ECD for ten minutes and then turn it back on.
| Study group | Role | What they receive |
|---|---|---|
| PD, DBS, healthy controls | Other | Patients with idiopathic PD before or after DBS surgery (during on or off-stimulation) and healthy controls. Receives: Radiation: Injection of 15mCi of Tc-ECD and scanning by SPECT camera; Behavioral: Semantic verbal fluency task performance; Device: Turning off the stimulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
CBF values in different brain regions
Measured: 3 months to 2 years post-surgery
Secondary outcomes (1)
Number of words produced in the semantic fluency task
Measured: 3 months to 2 years post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2009 (estimated)
- Study startFeb 2006
- Primary completionApr 2010 (estimated)
- Study completionOct 2010 (estimated)
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 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01037686
- Sponsor's protocol ID
- SHEBA-05-3972-SH-CTIL
- Status last verified
- Dec 2009
- First submitted
- 29 Sep 2009
- Last updated
- 23 Dec 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Effect of Electrode Implantation for DBS on Brain Function During Rest and During Semantic Verbal Fluency Task Using SPECT With Tc-ECD
- ClinicalTrials.gov ID
- NCT01037686
- Acronym / sponsor ID
- SHEBA-05-3972-SH-CTIL
- Conditions
- Parkinson's Disease, Deep Brain Stimulation
- Keywords
- PD, DBS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Feb 2006
- Primary completion
- Apr 2010 (estimated)
- Study completion
- Oct 2010 (estimated)
- First posted
- 23 Dec 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.
The goal of this study is to explore the effect of subthalamic nucleus (STN)-DBS surgery and stimulation in PD (Parkinson's disease) patients on regional cerebral blood (CBF) flow during cognitive task performance or at rest.
Detailed description
In this study subjects undergo SPECT scans for CBF mapping. PD patients before the surgery and healthy controls undergo two scans. PD patients after the surgery undergo four scans. PD patients who undergo two scans before the surgery, undergo only two scans after the surgery.
Uptake of Tc-ECD, a CBF radiotracer, is done in the following conditions:
- For PD patients before the surgery - during the performance of the semantic verbal fluency task or at rest (total of 2 scans).
- For PD patients after the surgery- during the performance of the semantic verbal fluency task or at rest, either at on-stimulation or off-stimulation condition (total of 4 scans). The stimulator is turned off by the neurologist for 10 min.
- PD patients before and after the surgery- during performance of the semantic verbal fluency task or at rest before the surgery and during performance of the semantic verbal fluency task or at rest after the surgery only at off-stimulation condition (Total of 4 scans).
- Healthy controls - during the performance of the semantic verbal fluency task or at rest (total of 2 scans).
Following the Tc-ECD injection, the subjects are scanned by Irix SPECT camera for 15min.
Scans are analyzed and the regional CBF is measured using imaging software. Statistical analysis is done to discover the effect of the surgery, stimulation and the disease on blood flow at rest and during task performance. In addition, differences between groups in number of words produced during the task are also statistically analyzed.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PD, DBS, healthy controls | Other | Radiation: Injection of 15mCi of Tc-ECD and scanning by SPECT camera, Behavioral: Semantic verbal fluency task performance, Device: Turning off the stimulatorPatients with idiopathic PD before or after DBS surgery (during on or off-stimulation) and healthy controls. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Progressive idiopathic PD
- For control group - age-matched to study groups
Key exclusion criteria (6 listed)
- Progressive dementia or other psychiatric disorders
- Other neurological conditions
- Other physical disease
- Intolerance of "off stimulation" state
- Involuntary head motions
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 |
|---|---|---|
| Injection of 15mCi of Tc-ECD and scanning by SPECT cameraAll subjects (PD patients with or without DBS and healthy controls) will be injected with 15mCi of Tc-ECD and afterwards will be scanned by an Irix SPECT camera. | Radiation | PD, DBS, healthy controls |
| Semantic verbal fluency task performanceAll Subjects (PD patients with or without DBS and healthy controls) before one of the two scans will perform the semantic verbal fluency task during the Tc-ECD uptake for 9 minutes. Before the other scan subjects will be at rest. | Behavioural | PD, DBS, healthy controls |
| Turning off the stimulatorFor PD patients treated with DBS, the neurologist will turn off the stimulator after the injection of Tc-ECD for ten minutes and then turn it back on. | Device | PD, DBS, healthy controls |
Primary outcome
CBF values in different brain regions
Time frame: 3 months to 2 years post-surgery
1 secondary outcome
Number of words produced in the semantic fluency task
Time frame: 3 months to 2 years post-surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2009.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Injection of 15mCi of Tc-ECD and scanning by SPECT camera, Semantic verbal fluency task performance and Turning off the stimulator in people with Parkinson's Disease and Deep Brain Stimulation, 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 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 23 Dec 2009. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sharon Hassin, MD (97235305791, sharon.hassin@sheba.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CBF values in different brain regions (time frame: 3 months to 2 years post-surgery). 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 Dec 2009.