Ignite Creation Date:
2024-05-06 @ 7:50 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06153017
Status:
RECRUITING
Last Update Posted:
2023-12-01
First Post:
2023-06-14
Brief Title:
iTMS - Implementing Transcranial Magnetic Stimulation TMS to Assess Cortico-spinal Tract Integrity
Sponsor:
University of Aarhus
Organization:
University of Aarhus
Study Overview
Official Title:
iTMS - Implementing Transcranial Magnetic Stimulation TMS to Assess Cortico-spinal Tract Integrity
Status:
RECRUITING
Status Verified Date:
2023-11
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:
iTMS
Brief Summary:
Reliable prediction of upper limb UL function can guide clinicians in choosing relevant treatment helps to set realistic goals for rehabilitation and will contribute to personalized and effective rehabilitation TMS has been identified as a strong predictor of future UL function after stroke With this project the investigators want to implement the standard use of TMS examination for a defined patient group in the clinical setting and systematically evaluate the implementation process The impact and perceived value of TMS in the clinical setting will be evaluated and the predictive value of TMS for the specific patient population will be assessed
Detailed Description:
Design Design A prospective longitudinal implementation study Setting and population The implementation will take place at Hammel Neurorehabilitation Centre and University Research Clinic The target population are patients with stroke
Management The study will be organized by the Research Unit at Hammel Neurocenter Iris Brunner associate professor PhD in collaboration with the Center Management represented by head physician Kåre Eg Severinsen MD PhD and the unit for professional development represented by Camilla Biering Lundquist PhD
Evaluation of the implementation The RE-AIM framework and its extension the Practical Implementation Sustainability Model PRISM framework will be applied to guide and evaluate the implementation process The RE-AIM framework has been used in numerous studies and hosts a homepage with comprehensive online resources for planning evaluating and reporting implementation studies
Briefly it consists of the following components to evaluate the success of an implementation
Reach Refers to percent of individuals who are reached by the intervention In the context of the present study Reach would describe the number of patients for whom the TMS examination would be relevant and the percentage of patients who received TMS and reasons for not being examined
- Evaluation of Reach through monitoring of 4 selected wards with the help of the Business Intelligence BI portal
Effectiveness Entails the measurement of primary and broader outcomes In this study Effectiveness would assess the prediction accuracy for the specific population at the hospital
- Evaluation of Effectiveness Fifty patients will be recruited consecutively from all wards at Hammel Neurorehabilitation Centers sites Hammel and Skive Follow-up assessments of UL function will be conducted at 3 months post-stroke with the tests of UL function described in 3d It will be assessed if individual predictions based on TMS and clinical tests will reach a specificity of 80 or more In addition sensitivity PPV NPV and overall accuracy CCP including 95 CI will be calculated
Adoption The level of actual uptake of the new intervention Specifically in this study the number of referrals of relevant patients from different wards Moreover the number of involved staff therapists MDs with a positive attitude to the TMS examination
- Evaluation of adoption will based on quantitative data from monitoring questionnaires and interviews
Implementation Description of the actual resources and cost allocated intervention fidelity and acceptance
- Implementation is evaluated with regard to intervention fidelity In this case can patients be examined with TMS within the planned time after stroke and is the workload for trained examiners distributed as agreed on
Maintenance Measures the long-term attrition to an intervention on an individual and a setting level
- Among others the following questions will be addressed Are the potential obstacles identified in previous components of reach addressed Is the rate of patients referred to TMS stable over time Can examination skills be maintained or is there need for a boost Has new staff been introduced to perform the TMS procedure Based on these questions and the feedback from questionnaires and interviews the investigators will continuously respond to threats to maintenance and adapt maintenance strategies accordingly
Management The study will be organized by the Research Unit at Hammel Neurocenter Iris Brunner associate professor PhD in collaboration with the Center Management represented by head physician Kåre Eg Severinsen MD PhD and the unit for professional development represented by Camilla Biering Lundquist PhD
Evaluation of the implementation The RE-AIM framework and its extension the Practical Implementation Sustainability Model PRISM framework will be applied to guide and evaluate the implementation process The RE-AIM framework has been used in numerous studies and hosts a homepage with comprehensive online resources for planning evaluating and reporting implementation studies
Briefly it consists of the following components to evaluate the success of an implementation
Reach Refers to percent of individuals who are reached by the intervention In the context of the present study Reach would describe the number of patients for whom the TMS examination would be relevant and the percentage of patients who received TMS and reasons for not being examined
- Evaluation of Reach through monitoring of 4 selected wards with the help of the Business Intelligence BI portal
Effectiveness Entails the measurement of primary and broader outcomes In this study Effectiveness would assess the prediction accuracy for the specific population at the hospital
- Evaluation of Effectiveness Fifty patients will be recruited consecutively from all wards at Hammel Neurorehabilitation Centers sites Hammel and Skive Follow-up assessments of UL function will be conducted at 3 months post-stroke with the tests of UL function described in 3d It will be assessed if individual predictions based on TMS and clinical tests will reach a specificity of 80 or more In addition sensitivity PPV NPV and overall accuracy CCP including 95 CI will be calculated
Adoption The level of actual uptake of the new intervention Specifically in this study the number of referrals of relevant patients from different wards Moreover the number of involved staff therapists MDs with a positive attitude to the TMS examination
- Evaluation of adoption will based on quantitative data from monitoring questionnaires and interviews
Implementation Description of the actual resources and cost allocated intervention fidelity and acceptance
- Implementation is evaluated with regard to intervention fidelity In this case can patients be examined with TMS within the planned time after stroke and is the workload for trained examiners distributed as agreed on
Maintenance Measures the long-term attrition to an intervention on an individual and a setting level
- Among others the following questions will be addressed Are the potential obstacles identified in previous components of reach addressed Is the rate of patients referred to TMS stable over time Can examination skills be maintained or is there need for a boost Has new staff been introduced to perform the TMS procedure Based on these questions and the feedback from questionnaires and interviews the investigators will continuously respond to threats to maintenance and adapt maintenance strategies accordingly
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