Ignite Creation Date:
2024-05-06 @ 7:19 PM
Last Modification Date:
2024-10-26 @ 3:05 PM
Study NCT ID:
NCT05977088
Status:
RECRUITING
Last Update Posted:
2024-02-07
First Post:
2023-06-02
Brief Title:
Prediction of Effectiveness of rTMS Application in Alzheimers Patients
Sponsor:
Istanbul Medipol University Hospital
Organization:
Istanbul Medipol University Hospital
Study Overview
Official Title:
Prediction of Cognitive Neurotrophic Anti-Inflammatory and Antioxidant Effectiveness of rTMS Application in Alzheimers Patients
Status:
RECRUITING
Status Verified Date:
2024-02
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:
Since pharmacological methods are insufficient in the treatment processes of Alzheimers disease non-pharmacological methods such as Transcranial Magnetic Stimulation TMS have started to be tried as a treatment option as in other neurological and psychiatric diseases Repeated rTMS offers a potential treatment pathway for neurological and psychiatric illnesses rTMS benefit rate may vary depending on many factors such as the region where it is applied the progression and the disease degree The possible effects of TMS on Alzheimers pathophysiology and modification of disease process neuroprotective anti-inflammatory and antioxidant will also be revealed through blood samples taken from patients before and after treatment These approaches also constitute the original value of our study
Detailed Description:
Since pharmacological methods are insufficient in the treatment processes of Alzheimers disease non-pharmacological methods such as Transcranial Magnetic Stimulation TMS have started to be tried as a treatment option as in other neurological and psychiatric diseases Repeated rTMS offers a potential treatment pathway for neurological and psychiatric illnesses rTMS benefit rate may vary depending on many factors such as the region where it is applied the progression and the disease degree This study aim is to predict the benefit rate to be obtained from the treatment by using various evaluation parameters before starting rTMS treatment The possible effects of TMS on Alzheimers pathophysiology and modification of disease process neuroprotective anti-inflammatory and antioxidant will also be revealed through blood samples taken from patients before and after treatment These approaches also constitute the original value of our study
In our project 20 people will be included in the study and control groups and electroencephalography EEG and TMS will be used together in the study Before rTMS treatment resting EEG data will be taken for 5 minutes eyes open and closed At the end of all these procedures rTMS treatment will be started which will take 5 days The treatment will consist of two sessions per day with a 20 Hz stimulating protocol 1500 beats to right-left DLPFC and totaly 3000 beats EEG recordings will be taken again from all patients one week after the treatment
Changes in the cognitive functions of Alzheimers patients will be made through the neuropsychometric test battery taken before and after rTMS With the analysis of neuropsychometric data the study group will be divided into two subgroups that benefit from TMS and those who do not In addition EEG data obtained before and after-TMS will be compared with power spectrum coherence functional connectivity and graph methods in both the study and control groups and information about the electrophysiological effects of TMS will be obtained
Blood samples of the patients before and after rTMS will be taken and the changes in the metabolites given below will be compared Brain Derived Neurotrophic Factor Glial Based Neurotrophic Factor Total Oxidant Level Total Antioxidant Level Oxidative Stress Index Total Thiol Native Thiol Disulfide Exosome Inflammation Biomarkers interleukin 1 Beta interleukin 6 Tumor Necrosis Alpha Interferon gamma Nuclear factor kappa ß Albumin Globulin ratio Omega 6 and Omega 3 Thus rTMS has possible neuroprotective anti-inflammatory and antioxidant effects consequently modifying the disease process Additional information will be obtained about
In our project 20 people will be included in the study and control groups and electroencephalography EEG and TMS will be used together in the study Before rTMS treatment resting EEG data will be taken for 5 minutes eyes open and closed At the end of all these procedures rTMS treatment will be started which will take 5 days The treatment will consist of two sessions per day with a 20 Hz stimulating protocol 1500 beats to right-left DLPFC and totaly 3000 beats EEG recordings will be taken again from all patients one week after the treatment
Changes in the cognitive functions of Alzheimers patients will be made through the neuropsychometric test battery taken before and after rTMS With the analysis of neuropsychometric data the study group will be divided into two subgroups that benefit from TMS and those who do not In addition EEG data obtained before and after-TMS will be compared with power spectrum coherence functional connectivity and graph methods in both the study and control groups and information about the electrophysiological effects of TMS will be obtained
Blood samples of the patients before and after rTMS will be taken and the changes in the metabolites given below will be compared Brain Derived Neurotrophic Factor Glial Based Neurotrophic Factor Total Oxidant Level Total Antioxidant Level Oxidative Stress Index Total Thiol Native Thiol Disulfide Exosome Inflammation Biomarkers interleukin 1 Beta interleukin 6 Tumor Necrosis Alpha Interferon gamma Nuclear factor kappa ß Albumin Globulin ratio Omega 6 and Omega 3 Thus rTMS has possible neuroprotective anti-inflammatory and antioxidant effects consequently modifying the disease process Additional information will be obtained about
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