Cognitive Decline Clinical Trial
— NextGen-SEOfficial title:
Next Generation Sequencing Diagnostics - On the Road to Rapid Diagnostics for Rare Diseases
NCT number | NCT02588638 |
Other study ID # | NextGen-SE |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | December 2015 |
Est. completion date | September 2023 |
In the study, NextGen SE are on-hand a cohort comprising each 50 pediatric and 50 adult patients, and in which there are an unclear movement disorder or an unclear cognitive disorder, examines the following questions : Primary: - Number of diagnoses made by NGS Secondary: 1. restriction of the quality of life by unclear disease 2. Cost of not purposeful preliminary diagnostics ( beyond the minimal diagnostic data set ) 3. Impact of the diagnosis to therapy and follow-up examinations 4. Time to diagnosis
Status | Recruiting |
Enrollment | 100 |
Est. completion date | September 2023 |
Est. primary completion date | June 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: For patients> 18 years 1. Unclear movement disorder o Progressive ataxia after minimal exclusion diagnostics: magnetic resonance tomography (MRT) (structural lesions such as cerebellar tumor, malformation) Laboratory (Vitamin B12, thyroid peroxidase (TPO) antibodies, glutamate decarboxylase (GAD) II-antibodies (AK) In medullary lesions: Liquor exclusion Friedreich ataxia (FRDA) and spinocerebellar ataxia type (SCA)1-2-3-6 o Progressive para-spasticity by minimal exclusion diagnostics: MRT neuro axis (structural lesions such as cervical myelopathy) Laboratory (Vitamin B12, human T-cell lymphotrophic virus ((HTLV)-AK) In medullary lesions: Liquor 2. Unclear cognitive decline o After minimal exclusion diagnosis MRT (intracranial pressure, focal brain lesions explanatory) laboratory (Thyroid-stimulating hormone (TSH), TPO-AK, antibody profile limbic encephalitis) Liquor (inflammation, meningitis) Electroencephalography (EEG) (Status) Exclusion chromosome 9 open reading frame 72 (C9orf72) For patients <18 years Patients with (penetrating) suspected cerebral neurogenetic diseases - Unclear movement disorder (spasticity, ataxia, dyskinesia) - Unclear cognitive disorder with probability of monogenic origin - Fragile X Syndrome (Fra-X) at mentally retarded boy, Friedreich ataxia (FRDA) with ataxia should be genetically excluded Exclusion Criteria: For patients > 18 years 1. Lack of consent 2. symptom onset > 40 years of age 3. Sudden, abrupt beginning 4. As early as previous history of genetic diagnosis using next-generation sequencing (NGS), also in the form of a panel For patients <18 years 1. injury brain disorders - On the basis of imaging - On the basis of medical history (premature baby, hypoxic-ischemic encephalopathy) 2. Inflammatory brain disorders - On the basis of imaging - On the basis of laboratory parameters (Oligoclonal fractions, cerebrospinal fluid (CSF) cell count increased) 3. Light, isolated mental developmental disorder or behavioral disorder (rare monogenetic) - (less than 2 standard deviartion of normal or - < 6 year olds - less than 1 year in development history back) 4. Sudden , abrupt beginning 5. Next-generation sequencing (NGS) also in the form of a panel |
Country | Name | City | State |
---|---|---|---|
Germany | University Hospital | Tubingen | Baden-Württemberg |
Lead Sponsor | Collaborator |
---|---|
University Hospital Tuebingen |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of diagnoses made by next gereration sequency (NGS) | Within the study period of 18 months | ||
Secondary | Restriction of the quality of life by unclear disease measured rated by Quality of Life Questionnaire (EQ5D), Depression Questionnaire (PHQ) | EQ-5D: Calculation preference value PHQ: Categorical analysis carried out by modified evaluation algorithms of the Diagnostic and Statistical Manual of Mental Disorders (DSM) -IV B | At day 1 | |
Secondary | Cost of not purposeful preliminary diagnostics rated by questionnaire on costs (number of outpatient performances, stationary investigations, repetition 's imaging, genetic single diagnostics, high-priced diagnostic | At day 1 | ||
Secondary | Time to diagnosis | For patients whose diagnosis can be made by NGS | At day 1 |
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