DystoniaPhase 4NCT02263417
A Randomized Controlled Trail Comparing Subthalamic and Pallidal Deep Brain Stimulation for Dystonia
A Phase 4 study testing Deep Brain Stimulation (DBS) of Gpi and Deep Brain Stimulation (DBS) of STN in people with Dystonia, run by Beijing Pins Medical Co., Ltd at 1 site in China.
Trial summary
The purpose of this study was to compare the subthalamic nucleus(STN) with the globus pallidus internus(GPi) as a stimulation target for deep brian stimulation(DBS) for medically refractory dystonia. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Dystonia
- What is being tested?
- Deep Brain Stimulation (DBS) of Gpi and Deep Brain Stimulation (DBS) of STN
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- Jul 2015to Jun 2020
- Phase
- Phase 4
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is aged 18 to 75 years old, male or female.
- Diagnosed with cervical dystonia by a movement disorders neurologist.
- Has cervical dystonia alone, not generalized or multifocal.
- Has had adequate trials of medical therapy.
Who cannot join
- Cognitive impairment.
- Abnormalities on pre-operative magnetic resonance imaging (MRI).
- Medical conditions precluding general anaesthetic or surgery.
- Unstable psychiatric disease.
- Previous brain lesions to treat cervical dystonia.
- Attended some other trials within three month.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking union medical college hospital
Beijing, Beijing Municipality, 100032
About this study
Official title: The Safety and Efficacy of Long-term Treatment of PINS Stimulator System for Patients With Dystonia
The purpose of this study was to compare the subthalamic nucleus(STN) with the globus pallidus internus(GPi) as a stimulation target for deep brian stimulation(DBS) for medically refractory dystonia.
Read the detailed description
In this prospective randomized controlled study,elecrodes were bilaterally implanted in STN and Gpi of 40 patients with dystonia.
- Conditions
- Dystonia
- Being tested
- Deep Brain Stimulation (DBS) of Gpi, Deep Brain Stimulation (DBS) of STN
- Medical subject headings
- Dystonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep Brain Stimulation (DBS) of GpiDevice
Also called Rechargeable Neurostimulator
Deep Brain Stimulation (DBS) of STNDevice
Also called Rechargeable Neurostimulator
| Study group | Role | What they receive |
|---|---|---|
| Deep Brain Stimulation | Active comparator | Stimulation is on Receives: Device: Deep Brain Stimulation (DBS) of Gpi; Device: Deep Brain Stimulation (DBS) of STN |
| Placebo | Sham comparator | Stimulation is off Receives: Device: Deep Brain Stimulation (DBS) of Gpi; Device: Deep Brain Stimulation (DBS) of STN |
What is being measured
The primary outcome is the main question the study is designed to answer.
Burke-Fahn-Marsden Scale (BFM)
Measured: Change from baseline in BMF at 1, 3 months and 6 months
Secondary outcomes (2)
Quality of life (SF-36)
Measured: Change from baseline in SF-36 at 1, 3 months and 6 months
Psychiatric assessment (HADS-D and PANSS)
Measured: Change from baseline in HADS-D and PANSS at 1, 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2014 (estimated)
- Study startJul 2015
- Primary completionDec 2019
- Study completionJun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DystoniaStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Pins Medical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Peking Union Medical College Hospital
- Responsible party
- Sponsor
- Investigators
- Li Luming, PhD, Study chair, Tsinghua University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02263417
- Sponsor's protocol ID
- PINS-005
- Status last verified
- Feb 2023
- First submitted
- 27 Sep 2014
- Last updated
- 1 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Efficacy of Long-term Treatment of PINS Stimulator System for Patients With Dystonia
- ClinicalTrials.gov ID
- NCT02263417
- Acronym / sponsor ID
- PINS-005
- Conditions
- Dystonia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Beijing Pins Medical Co., LtdIndustry (pharma, biotech, devices)
- Collaborators
- Peking Union Medical College Hospital
- Study start
- Jul 2015
- Primary completion
- Dec 2019 (actual)
- Study completion
- Jun 2020 (actual)
- First posted
- 13 Oct 2014 (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 was to compare the subthalamic nucleus(STN) with the globus pallidus internus(GPi) as a stimulation target for deep brian stimulation(DBS) for medically refractory dystonia.
Detailed description
In this prospective randomized controlled study,elecrodes were bilaterally implanted in STN and Gpi of 40 patients with dystonia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Deep Brain Stimulation | Active comparator | Device: Deep Brain Stimulation (DBS) of Gpi, Device: Deep Brain Stimulation (DBS) of STNStimulation is on |
| Placebo | Sham comparator | Device: Deep Brain Stimulation (DBS) of Gpi, Device: Deep Brain Stimulation (DBS) of STNStimulation is off |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subject is aged 18 to 75 years old, male or female.
- Diagnosed with cervical dystonia by a movement disorders neurologist.
- Has cervical dystonia alone, not generalized or multifocal.
- Has had adequate trials of medical therapy.
Key exclusion criteria (6 listed)
- Cognitive impairment.
- Abnormalities on pre-operative magnetic resonance imaging (MRI).
- Medical conditions precluding general anaesthetic or surgery.
- Unstable psychiatric disease.
- Previous brain lesions to treat cervical dystonia.
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 |
|---|---|---|
| Deep Brain Stimulation (DBS) of GpiAlso: Rechargeable Neurostimulator | Device | Deep Brain Stimulation, Placebo |
| Deep Brain Stimulation (DBS) of STNAlso: Rechargeable Neurostimulator | Device | Deep Brain Stimulation, Placebo |
Primary outcome
Burke-Fahn-Marsden Scale (BFM)
Time frame: Change from baseline in BMF at 1, 3 months and 6 months
2 secondary outcomes
Quality of life (SF-36)
Time frame: Change from baseline in SF-36 at 1, 3 months and 6 months
Psychiatric assessment (HADS-D and PANSS)
Time frame: Change from baseline in HADS-D and PANSS at 1, 3 months and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2023.
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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.
Li Luming, PhD study chair
Tsinghua University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Deep Brain Stimulation (DBS) of Gpi and Deep Brain Stimulation (DBS) of STN in people with Dystonia, run by Beijing Pins Medical Co., Ltd at 1 site in China.
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 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: finished, as of the sponsor's last update on 1 Mar 2023. 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 China. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Burke-Fahn-Marsden Scale (BFM) (time frame: Change from baseline in BMF at 1, 3 months and 6 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 1 Mar 2023.