Involuntary MovementsNCT04083586
Pattern and Frequency of Non-epileptic Involuntary Movements
An observational study of Involuntary Movements, run by Assiut University at 1 site in Egypt.
Trial summary
We will perform a medical record review of all patients seen in Assiut University hospital, Egypt, to determine the frequency of movement disorders seen, disease characteristics, diagnostic evaluations. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Involuntary Movements
- What is being tested?
- All investigations; laboratory and radiological, needed for diagnosis
- How many people
- 144 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jan 2020to 15 Jan 2021
- Phase
- Observational
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients with movement disorders attending Assiut University neurology outpatient clinic and internal department, from Jan 2020 to Jan 2021. sample size: regarding previously estimated prevalence in (kwon KY et al,2019), was 292, so our sample size as calculated: Sample Size(n) for Various Confidence Levels ________________________________________ Confidence Level(%) Sample Size 95% 167 80% 106 90% 141 97% 181 99% 203 99.9% 231 99.99% 245 ________________________________________ Equation Sample size n = [DEFF*Np(1-p)]/ [(d2/Z21-α/2*(N-1)+p*(1-p)] Results from OpenEpi, Version 3, open source calculator--SSPropor
Who may be able to join
- Patients with movement disorders attending Assiut University neurology outpatient clinic and internal department, from Jan 2020 to Jan 2021.
Who cannot join
- 1) involuntary movements epileptic in origin 2) refusal of patient to give consent to join the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pattern and Frequency of Non-epileptic Involuntary Movements. Hospital-based Study
We will perform a medical record review of all patients seen in Assiut University hospital, Egypt, to determine the frequency of movement disorders seen, disease characteristics, diagnostic evaluations.
Read the detailed description
Movement disorders are conventionally divided into major categories: 1) Hyperkinetic movement disorders (also called dyskinesias) refer to excessive, often repetitive, involuntary movements that intrude into the normal flow of motor activity. This category includes chorea, dystonia, myoclonus, stereotypies, tics, and tremor. 2) Hypokinetic movement 3) Ataxia.
Hyperkinetic movements any unwanted excess movement. Together with hypertonia (abnormally increased resistance to externally imposed movement) and negative signs (insufficient muscle activity or insufficient control of muscle activity).
Tremor: Tremor is a rhythmic back-and-forth or oscillating purposeless involuntary movement about a joint axis. Tremor occurs at rest (the pill-rolling tremor of Parkinsonism). Postural tremor (the fine tremor of hyperthyroidism), Action tremor (intention tremor) occurs near the end of a goal-directed movement.
Chorea : is a series of brief, jerky, explosive ongoing random-appearing sequence of one or more discrete involuntary movements, or "fidgeting; there are different causes of chorea, Sydenham's chorea. Lesions in the sub thalamic nucleus. Encephalitis with diffuse gray-matter. Motor impersistence is a common association.
Athetosis is a slow, continuous, writhing, sinuous movement, especially marked in the digits and extremities, prevents maintenance of a stable posture.
Myoclonus consists of sequence of repeated, often non-rhythmic sudden brief twitches or jerks or involuntary contraction or relaxation of one or more muscles as seen in metabolic encephalopathies such as uremic encephalopathy. It can be categorized as "action myoclonus", "postural myoclonus", or "rest myoclonus" based on the condition when it is observed Asterixis :is an intermittency of sustained posture, illustrated by "flapping" of the hands when the arms are outstretched and wrists dorsiflexed, as in hepatic encephalopathy.
Stereotypies are repetitive, simple movements that can be voluntarily suppressed. Stereotypies do not necessarily hold the person's attention.
Tics are repeated, individually recognizable, intermittent movements that are almost always briefly suppressible and are usually associated with awareness of an urge to perform the movement.
Dystonia: a movement disorder in which involuntary sustained or intermittent muscle contractions cause twisting and repetitive movements, abnormal postures, or both. Dystonic postures are often triggered by attempts at voluntary movement or voluntary posture, as may occur in task-specific dystonia.
Hypokinetic movements: include bradykinesia (slowness of movement) and hypokinesia (poverty of movement, and movements that are smaller than intended), but also crucially and fundamentally the progressive fatiguing and decrement of repetitive alternating movements seen during finger or foot tapping. The best known cause and example is Parkinson's disease.
Ataxia: Ataxia is a degenerative disorder affecting the brain, brainstem or spinal cord. This can result in clumsiness, inaccuracy, instability, imbalance, tremor or a lack of coordination while performing voluntary movements. Ataxia also can affect speech and movement of the eyes.
Previous epidemiological studies in Egypt showed that the Overall the recorded Crude Prevalence Rate (CPR) of Parkinson's disease in Egypt was varied in different governorates and ranged from 53 to 557/105 inhabitants Another study was planned to estimate the prevalence and to study the aetiological factors of chorea, dystonia, athetosis and hemiballismus in Assiut. The prevalence rate for rheumatic chorea was 62/100,000 population, whereas Huntington's chorea had a prevalence rate of 21/100,000. The other two common types of chorea were reported with prevalence rates of 12/100,000 for the encephalitic type and 17/100,000 for the atherosclerotic type. No single case of generalized dystonia was recorded and all cases were of the focal type of dystonia with a prevalence rate of 26/100,000 population, but there's no available data about other movement disorders in Egypt
- Conditions
- Involuntary Movements
- Being tested
- All investigations; laboratory and radiological, needed for diagnosis
- Medical subject headings
- Dyskinesias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
All investigations; laboratory and radiological, needed for diagnosisOther
mri brain, ct brain, drug screening
What is being measured
The primary outcome is the main question the study is designed to answer.
•Detect pattern and clinical characteristics of patients with different forms of movement disorders attending Assiut University neurology outpatient clinic and internal department as parkinson's disease
Using MDS- Unified Parkinson's Disease Rating Scale (UPDRS) (Goetz et al., 2008) for PD. (parts 3) III: Motor Examination, The investigator should "rate what you see.concurrent medical problems and orthopedic problems may interfere with individual items in the motor examination. In situations where it is absolutely impossible to test use the notation "UR" for Unable to Rate. Otherwise, rate the performance of each task as the patient performs in the context of co-morbidities.Do higher values represent a worse outcome
Measured: from Dec15th 2019 to June15th 2020.
•Detect pattern and clinical characteristics of patients with different forms of movement disorders attending Assiut University neurology outpatient clinic and internal department as dystonia
using Fahn-Marsden rating scale (FMRS), for dystonia. The FMDRS is composed of two clinician-rated subscales: a movement subscale, based on patient examination, and a disability subscale, based on the patient's report of disability in activities of daily living.The movement subscale rates dystonia severity and provoking factors in nine body areas, All items have a 5-point score. The provoking factor rates the relation of dystonia to action, from 0 (no dystonia at rest or with action) to 4 (dystonia at rest).The maximal total FMDRS score is 120. The disability subscale is composed of 7 items for activities of daily living,providing a maximum disability sub- score of 30. Do higher values represent a worse outcome
Measured: from Dec15th 2019 to June15th 2020.
•Detect pattern and clinical characteristics of patients with different forms of movement disorders attending Assiut University neurology outpatient clinic and internal department as essential tremors
Using • Tremor assessment form (TAF) for tremor: A questionnaire related to hand tremor consisting of 12 items was prospectively applied to patients with PD or ET in three movement-disorder clinics. Each question was analyzed, and a query-based scoring system was evaluated for differentiating hand tremors between PD and ET
Measured: from Dec15th 2019 to June15th 2020.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2019
- Study start15 Jan 2020
- Primary completion15 Jan 2021
- Study completion15 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Involuntary MovementsStudies 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roaa Almoataz Abdelrazik Zohni Elsabrout, Assiut University
- Investigators
- Hamdy El-Tallawy, professor, Study chair, Professor of Neurology Faculty of Medicine, Assiut UniversityAli Shalash, professor, Study director, Professor of Neurology Faculty of Medicine, Ain Shams Universitymohamed abdelhameed, assist prof, Study director, Assistant professor of Neurology Faculty of Medicine, Assiut Universityroaa elsabrout, postgraduate, Principal investigator, Resident at neuropsychiatry department Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04083586
- Sponsor's protocol ID
- frequency involuntary movement
- Status last verified
- Aug 2021
- First submitted
- 29 Aug 2019
- Last updated
- 9 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Sanger TD, Delgado MR, Gaebler-Spira D, Hallett M, Mink JW; Task Force on Childhood Motor Disorders. Classification and definition of disorders causing hypertonia in childhood. Pediatrics. 2003 Jan;111(1):e89-97. doi: 10.1542/peds.111.1.e89.
PubMed 12509602Sanger TD, Chen D, Delgado MR, Gaebler-Spira D, Hallett M, Mink JW; Taskforce on Childhood Motor Disorders. Definition and classification of negative motor signs in childhood. Pediatrics. 2006 Nov;118(5):2159-67. doi: 10.1542/peds.2005-3016.
PubMed 17079590Swedo SE. Sydenham's chorea. A model for childhood autoimmune neuropsychiatric disorders. JAMA. 1994 Dec 14;272(22):1788-91. doi: 10.1001/jama.272.22.1788. No abstract available.
PubMed 7661914Benabid AL, Benazzouz A, Limousin P, Koudsie A, Krack P, Piallat B, Pollak P. Dyskinesias and the subthalamic nucleus. Ann Neurol. 2000 Apr;47(4 Suppl 1):S189-92.
PubMed 10762147Janavs JL, Aminoff MJ. Dystonia and chorea in acquired systemic disorders. J Neurol Neurosurg Psychiatry. 1998 Oct;65(4):436-45. doi: 10.1136/jnnp.65.4.436.
PubMed 9771763Cardoso F, Eduardo C, Silva AP, Mota CC. Chorea in fifty consecutive patients with rheumatic fever. Mov Disord. 1997 Sep;12(5):701-3. doi: 10.1002/mds.870120512.
PubMed 9380051Morris JG, Jankelowitz SK, Fung VS, Clouston PD, Hayes MW, Grattan-Smith P. Athetosis I: historical considerations. Mov Disord. 2002 Nov;17(6):1278-80. doi: 10.1002/mds.10267. No abstract available.
PubMed 12465068Caviness JN, Brown P. Myoclonus: current concepts and recent advances. Lancet Neurol. 2004 Oct;3(10):598-607. doi: 10.1016/S1474-4422(04)00880-4.
PubMed 15380156Kennedy CH, Meyer KA, Knowles T, Shukla S. Analyzing the multiple functions of stereotypical behavior for students with autism: implications for assessment and treatment. J Appl Behav Anal. 2000 Winter;33(4):559-71. doi: 10.1901/jaba.2000.33-559.
PubMed 11214031Swedo SE, Leonard HL, Garvey M, Mittleman B, Allen AJ, Perlmutter S, Lougee L, Dow S, Zamkoff J, Dubbert BK. Pediatric autoimmune neuropsychiatric disorders associated with streptococcal infections: clinical description of the first 50 cases. Am J Psychiatry. 1998 Feb;155(2):264-71. doi: 10.1176/ajp.155.2.264.
PubMed 9464208Meierkord H, Fish DR, Smith SJ, Scott CA, Shorvon SD, Marsden CD. Is nocturnal paroxysmal dystonia a form of frontal lobe epilepsy? Mov Disord. 1992;7(1):38-42. doi: 10.1002/mds.870070107.
PubMed 1557065El-Tallawy HN, Farghaly WM, Shehata GA, Rageh TA, Hakeem NM, Hamed MA, Badry R. Prevalence of Parkinson's disease and other types of Parkinsonism in Al Kharga district, Egypt. Neuropsychiatr Dis Treat. 2013;9:1821-6. doi: 10.2147/NDT.S48318. Epub 2013 Nov 26.
PubMed 24379673
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pattern and Frequency of Non-epileptic Involuntary Movements. Hospital-based Study
- ClinicalTrials.gov ID
- NCT04083586
- Acronym / sponsor ID
- frequency involuntary movement
- Conditions
- Involuntary Movements
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 Jan 2020 (actual)
- Primary completion
- 15 Jan 2021 (actual)
- Study completion
- 15 Jan 2021 (actual)
- First posted
- 10 Sep 2019 (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.
We will perform a medical record review of all patients seen in Assiut University hospital, Egypt, to determine the frequency of movement disorders seen, disease characteristics, diagnostic evaluations.
Detailed description
Movement disorders are conventionally divided into major categories: 1) Hyperkinetic movement disorders (also called dyskinesias) refer to excessive, often repetitive, involuntary movements that intrude into the normal flow of motor activity. This category includes chorea, dystonia, myoclonus, stereotypies, tics, and tremor. 2) Hypokinetic movement 3) Ataxia.
Hyperkinetic movements any unwanted excess movement. Together with hypertonia (abnormally increased resistance to externally imposed movement) and negative signs (insufficient muscle activity or insufficient control of muscle activity).
Tremor: Tremor is a rhythmic back-and-forth or oscillating purposeless involuntary movement about a joint axis. Tremor occurs at rest (the pill-rolling tremor of Parkinsonism). Postural tremor (the fine tremor of hyperthyroidism), Action tremor (intention tremor) occurs near the end of a goal-directed movement.
Chorea : is a series of brief, jerky, explosive ongoing random-appearing sequence of one or more discrete involuntary movements, or "fidgeting; there are different causes of chorea, Sydenham's chorea. Lesions in the sub thalamic nucleus. Encephalitis with diffuse gray-matter. Motor impersistence is a common association.
Athetosis is a slow, continuous, writhing, sinuous movement, especially marked in the digits and extremities, prevents maintenance of a stable posture.
Myoclonus consists of sequence of repeated, often non-rhythmic sudden brief twitches or jerks or involuntary contraction or relaxation of one or more muscles as seen in metabolic encephalopathies such as uremic encephalopathy. It can be categorized as "action myoclonus", "postural myoclonus", or "rest myoclonus" based on the condition when it is observed Asterixis :is an intermittency of sustained posture, illustrated by "flapping" of the hands when the arms are outstretched and wrists dorsiflexed, as in hepatic encephalopathy.
Stereotypies are repetitive, simple movements that can be voluntarily suppressed. Stereotypies do not necessarily hold the person's attention.
Tics are repeated, individually recognizable, intermittent movements that are almost always briefly suppressible and are usually associated with awareness of an urge to perform the movement.
Dystonia: a movement disorder in which involuntary sustained or intermittent muscle contractions cause twisting and repetitive movements, abnormal postures, or both. Dystonic postures are often triggered by attempts at voluntary movement or voluntary posture, as may occur in task-specific dystonia.
Hypokinetic movements: include bradykinesia (slowness of movement) and hypokinesia (poverty of movement, and movements that are smaller than intended), but also crucially and fundamentally the progressive fatiguing and decrement of repetitive alternating movements seen during finger or foot tapping. The best known cause and example is Parkinson's disease.
Ataxia: Ataxia is a degenerative disorder affecting the brain, brainstem or spinal cord. This can result in clumsiness, inaccuracy, instability, imbalance, tremor or a lack of coordination while performing voluntary movements. Ataxia also can affect speech and movement of the eyes.
Previous epidemiological studies in Egypt showed that the Overall the recorded Crude Prevalence Rate (CPR) of Parkinson's disease in Egypt was varied in different governorates and ranged from 53 to 557/105 inhabitants Another study was planned to estimate the prevalence and to study the aetiological factors of chorea, dystonia, athetosis and hemiballismus in Assiut. The prevalence rate for rheumatic chorea was 62/100,000 population, whereas Huntington's chorea had a prevalence rate of 21/100,000. The other two common types of chorea were reported with prevalence rates of 12/100,000 for the encephalitic type and 17/100,000 for the atherosclerotic type. No single case of generalized dystonia was recorded and all cases were of the focal type of dystonia with a prevalence rate of 26/100,000 population, but there's no available data about other movement disorders in Egypt
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with movement disorders attending Assiut University neurology outpatient clinic and internal department, from Jan 2020 to Jan 2021. sample size: regarding previously estimated prevalence in (kwon KY et al,2019), was 292, so our sample size as calculated: Sample Size(n) for Various Confidence Levels ________________________________________ Confidence Level(%) Sample Size 95% 167 80% 106 90% 141 97% 181 99% 203 99.9% 231 99.99% 245 ________________________________________ Equation Sample size n = [DEFF*Np(1-p)]/ [(d2/Z21-α/2*(N-1)+p*(1-p)] Results from OpenEpi, Version 3, open source calculator--SSPropor
Key inclusion criteria (1 listed)
- Patients with movement disorders attending Assiut University neurology outpatient clinic and internal department, from Jan 2020 to Jan 2021.
Key exclusion criteria (1 listed)
- 1) involuntary movements epileptic in origin 2) refusal of patient to give consent to join the study
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 |
|---|---|---|
| All investigations; laboratory and radiological, needed for diagnosismri brain, ct brain, drug screening | Other | – |
Primary outcome
•Detect pattern and clinical characteristics of patients with different forms of movement disorders attending Assiut University neurology outpatient clinic and internal department as parkinson's disease
Time frame: from Dec15th 2019 to June15th 2020.
Using MDS- Unified Parkinson's Disease Rating Scale (UPDRS) (Goetz et al., 2008) for PD. (parts 3) III: Motor Examination, The investigator should "rate what you see.concurrent medical problems and orthopedic problems may interfere with individual items in the motor examination. In situations where it is absolutely impossible to test use the notation "UR" for Unable to Rate. Otherwise, rate the performance of each task as the patient performs in the context of co-morbidities.Do higher values represent a worse outcome
•Detect pattern and clinical characteristics of patients with different forms of movement disorders attending Assiut University neurology outpatient clinic and internal department as dystonia
Time frame: from Dec15th 2019 to June15th 2020.
using Fahn-Marsden rating scale (FMRS), for dystonia. The FMDRS is composed of two clinician-rated subscales: a movement subscale, based on patient examination, and a disability subscale, based on the patient's report of disability in activities of daily living.The movement subscale rates dystonia severity and provoking factors in nine body areas, All items have a 5-point score. The provoking factor rates the relation of dystonia to action, from 0 (no dystonia at rest or with action) to 4 (dystonia at rest).The maximal total FMDRS score is 120. The disability subscale is composed of 7 items for activities of daily living,providing a maximum disability sub- score of 30. Do higher values represent a worse outcome
•Detect pattern and clinical characteristics of patients with different forms of movement disorders attending Assiut University neurology outpatient clinic and internal department as essential tremors
Time frame: from Dec15th 2019 to June15th 2020.
Using • Tremor assessment form (TAF) for tremor: A questionnaire related to hand tremor consisting of 12 items was prospectively applied to patients with PD or ET in three movement-disorder clinics. Each question was analyzed, and a query-based scoring system was evaluated for differentiating hand tremors between PD and ET
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 9 Aug 2021.
- Background: PubMed 12509602Sanger TD, Delgado MR, Gaebler-Spira D, Hallett M, Mink JW; Task Force on Childhood Motor Disorders. Classification and definition of disorders causing hypertonia in childhood. Pediatrics. 2003 Jan;111(1):e89-97. doi: 10.1542/peds.111.1.e89.
- Background: PubMed 17079590Sanger TD, Chen D, Delgado MR, Gaebler-Spira D, Hallett M, Mink JW; Taskforce on Childhood Motor Disorders. Definition and classification of negative motor signs in childhood. Pediatrics. 2006 Nov;118(5):2159-67. doi: 10.1542/peds.2005-3016.
- Background: PubMed 7661914Swedo SE. Sydenham's chorea. A model for childhood autoimmune neuropsychiatric disorders. JAMA. 1994 Dec 14;272(22):1788-91. doi: 10.1001/jama.272.22.1788. No abstract available.
- Background: PubMed 10762147Benabid AL, Benazzouz A, Limousin P, Koudsie A, Krack P, Piallat B, Pollak P. Dyskinesias and the subthalamic nucleus. Ann Neurol. 2000 Apr;47(4 Suppl 1):S189-92.
- Background: PubMed 9771763Janavs JL, Aminoff MJ. Dystonia and chorea in acquired systemic disorders. J Neurol Neurosurg Psychiatry. 1998 Oct;65(4):436-45. doi: 10.1136/jnnp.65.4.436.
- Background: PubMed 9380051Cardoso F, Eduardo C, Silva AP, Mota CC. Chorea in fifty consecutive patients with rheumatic fever. Mov Disord. 1997 Sep;12(5):701-3. doi: 10.1002/mds.870120512.
- Background: PubMed 12465068Morris JG, Jankelowitz SK, Fung VS, Clouston PD, Hayes MW, Grattan-Smith P. Athetosis I: historical considerations. Mov Disord. 2002 Nov;17(6):1278-80. doi: 10.1002/mds.10267. No abstract available.
- Background: PubMed 15380156Caviness JN, Brown P. Myoclonus: current concepts and recent advances. Lancet Neurol. 2004 Oct;3(10):598-607. doi: 10.1016/S1474-4422(04)00880-4.
- Background: PubMed 11214031Kennedy CH, Meyer KA, Knowles T, Shukla S. Analyzing the multiple functions of stereotypical behavior for students with autism: implications for assessment and treatment. J Appl Behav Anal. 2000 Winter;33(4):559-71. doi: 10.1901/jaba.2000.33-559.
- Background: PubMed 9464208Swedo SE, Leonard HL, Garvey M, Mittleman B, Allen AJ, Perlmutter S, Lougee L, Dow S, Zamkoff J, Dubbert BK. Pediatric autoimmune neuropsychiatric disorders associated with streptococcal infections: clinical description of the first 50 cases. Am J Psychiatry. 1998 Feb;155(2):264-71. doi: 10.1176/ajp.155.2.264.
- Background: PubMed 1557065Meierkord H, Fish DR, Smith SJ, Scott CA, Shorvon SD, Marsden CD. Is nocturnal paroxysmal dystonia a form of frontal lobe epilepsy? Mov Disord. 1992;7(1):38-42. doi: 10.1002/mds.870070107.
- Background: PubMed 24379673El-Tallawy HN, Farghaly WM, Shehata GA, Rageh TA, Hakeem NM, Hamed MA, Badry R. Prevalence of Parkinson's disease and other types of Parkinsonism in Al Kharga district, Egypt. Neuropsychiatr Dis Treat. 2013;9:1821-6. doi: 10.2147/NDT.S48318. Epub 2013 Nov 26.
- Individual participant dataSharing planned: Undecided
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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.
Hamdy El-Tallawy, professor study chair
Professor of Neurology Faculty of Medicine, Assiut University
Ali Shalash, professor study director
Professor of Neurology Faculty of Medicine, Ain Shams University
mohamed abdelhameed, assist prof study director
Assistant professor of Neurology Faculty of Medicine, Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Involuntary Movements, run by Assiut University at 1 site in Egypt.
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 1 inclusion and 1 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 9 Aug 2021. 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 Egypt. 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?
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?
•Detect pattern and clinical characteristics of patients with different forms of movement disorders attending Assiut University neurology outpatient clinic and internal department as parkinson's disease (time frame: from Dec15th 2019 to June15th 2020.). The study lists 3 primary outcomes in all. 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 NCT04083586, which also lists 12 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 9 Aug 2021.