Ignite Creation Date:
2024-05-06 @ 2:08 PM
Last Modification Date:
2024-10-26 @ 1:25 PM
Study NCT ID:
NCT04223180
Status:
COMPLETED
Last Update Posted:
2021-02-23
First Post:
2019-12-20
Brief Title:
Rehabilomics Study in Stroke Patients After Robotic Rehabilitation
Sponsor:
Fondazione Don Carlo Gnocchi Onlus
Organization:
Fondazione Don Carlo Gnocchi Onlus
Study Overview
Official Title:
Stroke Rehabilomics Study Epigenetics and Genetics Characterization of the BDNF and SLC6A4 Genes in Patients Undergoing Robotic Rehabilitation Treatment
Status:
COMPLETED
Status Verified Date:
2019-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Stroke is associated with disability and impaired quality of life Persistent motor impairment is common with incomplete recovery of motor function after rehabilitation mainly in the upper limbs UL Robot-mediated therapy RMT has been proposed as a viable approach for the rehabilitation of the UL but more rigorous studies are needed to tailor rehabilitation and to better address the treatment Brain-derived neurotrophic factor BDNF and the serotonin transporter gene SLC6A4 have been shown to play an important role in post-stroke recovery After ischemic stroke disruption and subsequent reorganization of functional brain connections occur both locally and far from the lesion with the latter possibly contributing to function recovery
This project aims to assess whether epigenetic and genetic variations of BDNF and SLC6A4 can occur in stroke patients after robotic rehabilitation treatment
This study will allow to identify potential genetic and epigenetic biomarkers in post-stroke rehabilitation that could be used to predict the response to a specific rehabilitation treatment and to choose the optimal treatment for the patient Rehabilomics
This project aims to assess whether epigenetic and genetic variations of BDNF and SLC6A4 can occur in stroke patients after robotic rehabilitation treatment
This study will allow to identify potential genetic and epigenetic biomarkers in post-stroke rehabilitation that could be used to predict the response to a specific rehabilitation treatment and to choose the optimal treatment for the patient Rehabilomics
Detailed Description:
Epigenetic and single-nucleotide polymorphisms SNPs in genes may influence an individuals capacity for use-dependent plasticity and hence their responsiveness to post-stroke rehabilitation Understanding genetic variation gives clinicians a biological signal that could be used to predict who is most likely to recover from neural injury to choose the optimal treatment for a patient or to supplement rehabilitation therapy
Robotics demonstrated to be an effective rehabilitation treatment for functional and motor recovery after stroke and on the basis of investigators preliminary results it seems to be an useful therapy to improve some cognitive functions The identification of individual characteristics is crucial factor to better address this treatment and to develop more tailored patients rehabilitation program
The characterization of the link between personal biology and rehabilitation treatment response will allow to define a model of Rehabilomics research as a translational framework for programs of precision rehabilitation and intervention research
In order to identify potential diagnostic and prognostic genetic biomarkers in post-stroke rehabilitation the investigators will analyze the promoter methylation of BDNF and SLC6A4 two genes implicated in sub-acute stroke recovery Moreover the investigators will also detect BDNF rs6265 and SLC6A4 5-HTTLPR polymorphisms
Subjects will be evaluated at baseline T0 after 30 sessions of rehabilitation treatment T1 and if possible after other 30 sessions of rehabilitation treatment from T1 T2
All patients will perform a robotic treatment of the upper limb 30 sessions 5 times a week using a set of robotic devices Where possible some patients will undergo further 30 robotic rehabilitation sessions after T1
Peripheral blood 6ml will be taken from all subjects at three time points T0 T1 and T2 during the rehabilitation treatment
Genomic DNA obtained from peripheral blood will be analyzed to evaluate promoter methylation of BDNF and SLC6A4 using pyrosequencing analysis with PyroMark Q24 Qiagen Germany
Moreover BDNF rs6265 polymorphism will be analyzed using HpyCH4IV restriction enzyme which identifies homozygous ValineValine heterozygous ValineMethionine and homozygous MethionineMethionine
For the SLC6A4 5-HTTLPR polymorphism the investigators will follow a specific protocol that identifies gene polymorphisms according to the polymerase chain reaction PCR fragment sizes short S 486 base pairs bp 14 repeats long L 529bp 16 repeats or extra long XL 612 or 654bp 20 or 22 repeats
Genetic and epigenetic results will be correlated with
i the effects of the robotic rehabilitation on the upper limb function and disability measured with the following clinical scales Fugl-Meyer Assessment for Upper Extremity FMA to evaluate motor function the Motricity Index MI to evaluate muscle strength the Modified Barthel Index mBI to evaluate activities of daily living ADL and mobility
ii the effects on cognitive functions measured with following cognitive tests 1 Digit Span attentionshort-term memory involving stringsseries of digits of varying length 2 Tower of London planning and problem solving 3 STROOP test Stroop Color and Word Test 4 Symbol Digit Modalities Test processing speed of visual stimuli 5 Rey-Osterrieth Complex Figure Test ROCF visuomotor integration
Robotics demonstrated to be an effective rehabilitation treatment for functional and motor recovery after stroke and on the basis of investigators preliminary results it seems to be an useful therapy to improve some cognitive functions The identification of individual characteristics is crucial factor to better address this treatment and to develop more tailored patients rehabilitation program
The characterization of the link between personal biology and rehabilitation treatment response will allow to define a model of Rehabilomics research as a translational framework for programs of precision rehabilitation and intervention research
In order to identify potential diagnostic and prognostic genetic biomarkers in post-stroke rehabilitation the investigators will analyze the promoter methylation of BDNF and SLC6A4 two genes implicated in sub-acute stroke recovery Moreover the investigators will also detect BDNF rs6265 and SLC6A4 5-HTTLPR polymorphisms
Subjects will be evaluated at baseline T0 after 30 sessions of rehabilitation treatment T1 and if possible after other 30 sessions of rehabilitation treatment from T1 T2
All patients will perform a robotic treatment of the upper limb 30 sessions 5 times a week using a set of robotic devices Where possible some patients will undergo further 30 robotic rehabilitation sessions after T1
Peripheral blood 6ml will be taken from all subjects at three time points T0 T1 and T2 during the rehabilitation treatment
Genomic DNA obtained from peripheral blood will be analyzed to evaluate promoter methylation of BDNF and SLC6A4 using pyrosequencing analysis with PyroMark Q24 Qiagen Germany
Moreover BDNF rs6265 polymorphism will be analyzed using HpyCH4IV restriction enzyme which identifies homozygous ValineValine heterozygous ValineMethionine and homozygous MethionineMethionine
For the SLC6A4 5-HTTLPR polymorphism the investigators will follow a specific protocol that identifies gene polymorphisms according to the polymerase chain reaction PCR fragment sizes short S 486 base pairs bp 14 repeats long L 529bp 16 repeats or extra long XL 612 or 654bp 20 or 22 repeats
Genetic and epigenetic results will be correlated with
i the effects of the robotic rehabilitation on the upper limb function and disability measured with the following clinical scales Fugl-Meyer Assessment for Upper Extremity FMA to evaluate motor function the Motricity Index MI to evaluate muscle strength the Modified Barthel Index mBI to evaluate activities of daily living ADL and mobility
ii the effects on cognitive functions measured with following cognitive tests 1 Digit Span attentionshort-term memory involving stringsseries of digits of varying length 2 Tower of London planning and problem solving 3 STROOP test Stroop Color and Word Test 4 Symbol Digit Modalities Test processing speed of visual stimuli 5 Rey-Osterrieth Complex Figure Test ROCF visuomotor integration
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None