Parkinson Disease, Essential Tremors and DystoniaNCT03562403
DBS in the Treatment of Intractable Movement Disorders
A study testing Deep Brain Stimulation in people with Parkinson Disease, Essential Tremors and Dystonia, run by Assiut University.
Trial summary
The aim of this study is to observe the efficacy of Deep Brain Stimulation in the treatment of Parkinson's disease,Essential Tremors and Dystonia in our locality. Read more about this study
- Who is it for?
- Ages 25 to 90 years
- Conditions the study is for
- Parkinson Disease, Essential Tremors and Dystonia
- What is being tested?
- Deep Brain Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- Jul 2018to Jul 2019
- 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 25 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Dopa responsiveness
- Minimum disease duration of 5 years.
- Diagnosis of idiopathic Parkinsons disease
- Patients with intractable Essential Tremors.
- Patients with intractable dystonia
Who cannot join
- Significant medical health problems.
- Significant cognitive impairment
- Bleeding tendencies
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Deep Brain Stimulation in the Treatment of Intractable Movement Disorders ( Parkinson's Disease, Essential Tremors and Dystonia)
The aim of this study is to observe the efficacy of Deep Brain Stimulation in the treatment of Parkinson's disease,Essential Tremors and Dystonia in our locality.
Read the detailed description
Movement disorders are clinical syndromes result from disturbances of basal ganglia function with either an excess of movement or a paucity of voluntary and involuntary movements, unrelated to weakness or spasticity. Movement disorders are synonymous with basal ganglia or extrapyramidal diseases. Movement disorders are conventionally divided into two major categories-hyperkinetic and hypokinetic.
Hyperkinetic movement disorders refer to excessive, often repetitive, involuntary movements that intrude upon the normal flow of motor activity and it includes include Essential Tremors, Dystonia, Chorea, Dyskinesia, and Athetosis.
Hypokinetic movement disorders refer to akinesia (lack of movement), hypokinesia (reduced amplitude of movements), bradykinesia (slow movement) and rigidity. In primary movement disorders, the abnormal movement is the primary manifestation of the disorder. In secondary movement disorders, the abnormal movement is a manifestation of another systemic or neurological disorder.
The basal ganglia include the striatum (caudate. putamen, nucleus accumbens), the subthalamic nucleus (STN), the globuspallidus [internal segment. external segment, ventral pallidum (VP)]. and the substantianigra pars compacta (SNpc) and substantianigra pars reticulata (SNpr).
Surgical therapies for the treatment of movement disorders can be divided into two broad categories: ablative and restorative. The most common structures targeted during stereotactic surgery for movement disorders are the motor thalamus, the globuspallidus internus and the subthalamic nucleus. Ablative surgical therapies for Movement disorders include thalamotomy and pallidotomy. Restorative surgical therapies include deep brain stimulation and transplantation of fetal tissue, cell lines that express trophic factors, or somatically delivered gene therapies. The theoretical advantage of Deep Brain Stimulation over ablative procedures is the lack of tissue destruction especially with deep brain stimulation. This is particularly appealing for patients needing bilateral procedures.
Parkinson's disease is the best example of a hypokinetic movement disorder. The interest in surgery has been prompted by the growing realization of the limitations of drug therapy for these movement disorders, improvement in neuroimaging capabilities, enhanced stereotactic surgical techniques and better understanding of functional organization of the basal ganglia and its pathophysiology of these movement disorders. There are many theories on how does Deep Brain Stimulation works in the treatment of movement disorders, these theories include Neurostimulation, Neuroinhibition, and Release of neurotransmitters. Deep brain has the following advantages over ablative surgery: No destruction of brain tissue can adjust stimulus parameters, Perform bilateral operations, significant reduction (50-75%) in medication, and it is completely reversible.
Since the introduction of deep brain stimulation almost 20 years ago, there has been an immense resurgence in interest in the surgical technique. However, the investigators are still asking some of the same questions. How can the investigators improve the targeting? What is the optimal target? In addition, the investigators have started asking some new questions such as how does deep brain stimulation work, and what other disorders can deep brain stimulation be applied to?
- Being tested
- Deep Brain Stimulation
- Keywords
- deep brain stimulation
- Medical subject headings
- Parkinson Disease, Essential Tremor, Dystonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep Brain StimulationDevice
stimulation of different basal ganglionic nuclei by a inserting a device
| Study group | Role | What they receive |
|---|---|---|
| DBS on patients with abnormal movement disorders | Experimental | 16 patients with intractable abnormal movement disorders (Parkinson's disease, Essential tremors and Dystonia) Receives: Device: Deep Brain Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the unified parkinson's disease rating scale score
The Unified Parkinson's Disease Rating Scale (UPDRS) is a commonly used survey tool used to assess symptom severity of patients with Parkinson's disease (PD). It covers several different domains including 1) thought, behavior and mood 2) activities of daily living 3) motor activity 4) complications of therapy and others.
Part I: evaluation of mentation, behavior, and mood Part II: self-evaluation of the activities of daily life (ADLs) including speech, swallowing, handwriting, dressing, hygiene, falling, salivating, turning in bed, walking, and cutting food Part III: clinician-scored monitored motor evaluation Part IV: complications of therapy Part V: Hoehn and Yahr staging of severity of Parkinson's disease Part VI: Schwab and England ADL scale
Measured: baseline(pre-DBS )and 6 months post-DBS
Secondary outcomes (1)
Change in antiparkinsonian medication use
the percent in reduction of antiparkinsonian medications used after DBS
Measured: baseline(pre-DBS and 6 months post-DBS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2018
- Study startJul 2018 (estimated)
- Primary completionApr 2019 (estimated)
- Study completionJul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Parkinson Disease, Essential Tremors and DystoniaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Radwan Nouby, Assiut University
- Investigators
- Amr Elnaggar, MD, Study director, University of Louisville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03562403
- Sponsor's protocol ID
- DBS in movement disorders
- Status last verified
- Jun 2018
- First submitted
- 22 May 2018
- Last updated
- 19 Jun 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Guttman M, Kish SJ, Furukawa Y. Current concepts in the diagnosis and management of Parkinson's disease. CMAJ. 2003 Feb 4;168(3):293-301.
PubMed 12566335Jankovic J, Cardoso F, Grossman RG, Hamilton WJ. Outcome after stereotactic thalamotomy for parkinsonian, essential, and other types of tremor. Neurosurgery. 1995 Oct;37(4):680-6; discussion 686-7. doi: 10.1227/00006123-199510000-00011.
PubMed 8559296
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deep Brain Stimulation in the Treatment of Intractable Movement Disorders ( Parkinson's Disease, Essential Tremors and Dystonia)
- ClinicalTrials.gov ID
- NCT03562403
- Acronym / sponsor ID
- DBS in movement disorders
- Keywords
- deep brain stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jul 2018 (estimated)
- Primary completion
- Apr 2019 (estimated)
- Study completion
- Jul 2019 (estimated)
- First posted
- 19 Jun 2018 (actual)
- 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 aim of this study is to observe the efficacy of Deep Brain Stimulation in the treatment of Parkinson's disease,Essential Tremors and Dystonia in our locality.
Detailed description
Movement disorders are clinical syndromes result from disturbances of basal ganglia function with either an excess of movement or a paucity of voluntary and involuntary movements, unrelated to weakness or spasticity. Movement disorders are synonymous with basal ganglia or extrapyramidal diseases. Movement disorders are conventionally divided into two major categories-hyperkinetic and hypokinetic.
Hyperkinetic movement disorders refer to excessive, often repetitive, involuntary movements that intrude upon the normal flow of motor activity and it includes include Essential Tremors, Dystonia, Chorea, Dyskinesia, and Athetosis.
Hypokinetic movement disorders refer to akinesia (lack of movement), hypokinesia (reduced amplitude of movements), bradykinesia (slow movement) and rigidity. In primary movement disorders, the abnormal movement is the primary manifestation of the disorder. In secondary movement disorders, the abnormal movement is a manifestation of another systemic or neurological disorder.
The basal ganglia include the striatum (caudate. putamen, nucleus accumbens), the subthalamic nucleus (STN), the globuspallidus [internal segment. external segment, ventral pallidum (VP)]. and the substantianigra pars compacta (SNpc) and substantianigra pars reticulata (SNpr).
Surgical therapies for the treatment of movement disorders can be divided into two broad categories: ablative and restorative. The most common structures targeted during stereotactic surgery for movement disorders are the motor thalamus, the globuspallidus internus and the subthalamic nucleus. Ablative surgical therapies for Movement disorders include thalamotomy and pallidotomy. Restorative surgical therapies include deep brain stimulation and transplantation of fetal tissue, cell lines that express trophic factors, or somatically delivered gene therapies. The theoretical advantage of Deep Brain Stimulation over ablative procedures is the lack of tissue destruction especially with deep brain stimulation. This is particularly appealing for patients needing bilateral procedures.
Parkinson's disease is the best example of a hypokinetic movement disorder. The interest in surgery has been prompted by the growing realization of the limitations of drug therapy for these movement disorders, improvement in neuroimaging capabilities, enhanced stereotactic surgical techniques and better understanding of functional organization of the basal ganglia and its pathophysiology of these movement disorders. There are many theories on how does Deep Brain Stimulation works in the treatment of movement disorders, these theories include Neurostimulation, Neuroinhibition, and Release of neurotransmitters. Deep brain has the following advantages over ablative surgery: No destruction of brain tissue can adjust stimulus parameters, Perform bilateral operations, significant reduction (50-75%) in medication, and it is completely reversible.
Since the introduction of deep brain stimulation almost 20 years ago, there has been an immense resurgence in interest in the surgical technique. However, the investigators are still asking some of the same questions. How can the investigators improve the targeting? What is the optimal target? In addition, the investigators have started asking some new questions such as how does deep brain stimulation work, and what other disorders can deep brain stimulation be applied to?
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DBS on patients with abnormal movement disorders | Experimental | Device: Deep Brain Stimulation16 patients with intractable abnormal movement disorders (Parkinson's disease, Essential tremors and Dystonia) |
Who may qualify
- Ages
- 25 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Dopa responsiveness
- Minimum disease duration of 5 years.
- Diagnosis of idiopathic Parkinsons disease
- Patients with intractable Essential Tremors.
- Patients with intractable dystonia
Key exclusion criteria (3 listed)
- Significant medical health problems.
- Significant cognitive impairment
- Bleeding tendencies
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 Stimulationstimulation of different basal ganglionic nuclei by a inserting a device | Device | DBS on patients with abnormal movement disorders |
Primary outcome
Change in the unified parkinson's disease rating scale score
Time frame: baseline(pre-DBS )and 6 months post-DBS
The Unified Parkinson's Disease Rating Scale (UPDRS) is a commonly used survey tool used to assess symptom severity of patients with Parkinson's disease (PD). It covers several different domains including 1) thought, behavior and mood 2) activities of daily living 3) motor activity 4) complications of therapy and others. Part I: evaluation of mentation, behavior, and mood Part II: self-evaluation of the activities of daily life (ADLs) including speech, swallowing, handwriting, dressing, hygiene, falling, salivating, turning in bed, walking, and cutting food Part III: clinician-scored monitored motor evaluation Part IV: complications of therapy Part V: Hoehn and Yahr staging of severity of Parkinson's disease Part VI: Schwab and England ADL scale
1 secondary outcome
Change in antiparkinsonian medication use
Time frame: baseline(pre-DBS and 6 months post-DBS
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2018.
- Results publication: PubMed 12566335Guttman M, Kish SJ, Furukawa Y. Current concepts in the diagnosis and management of Parkinson's disease. CMAJ. 2003 Feb 4;168(3):293-301.
- Results publication: PubMed 8559296Jankovic J, Cardoso F, Grossman RG, Hamilton WJ. Outcome after stereotactic thalamotomy for parkinsonian, essential, and other types of tremor. Neurosurgery. 1995 Oct;37(4):680-6; discussion 686-7. doi: 10.1227/00006123-199510000-00011.
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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.
Amr Elnaggar, MD study director
University of Louisville
Questions about this trial
What is this clinical trial studying?
A study testing Deep Brain Stimulation in people with Parkinson Disease, Essential Tremors and Dystonia, run by Assiut University.
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 3 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 Jun 2018. 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?
Contact Ahmed Nouby, masters degree (+201222336729, ahrano2015@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the unified parkinson's disease rating scale score (time frame: baseline(pre-DBS )and 6 months post-DBS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03562403, which also lists 2 linked publications.
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 Jun 2018.