Prediction of Effectiveness of rTMS Application in Alzheimer's Patients

NCT05977088 | Recruiting

• 1 other identifier: 221S749
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Since pharmacological methods are insufficient in the treatment processes of Alzheimer's 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 Alzheimer's 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.

Conditions

Alzheimer Disease

Keywords

Alzheimer's Disease; TMS-EEG; Anti-inflammatory-neuroprotective-antioxidant effect

Outcome Measures

Primary Outcomes (5)

• The Mini Mental State Examination

  Cognitive Neuropsychological Test Score

  Changes Before Treatment and 1 month after treatment

• Neuropsychiatric Inventory

  Cognitive Neuropsychological Test Score

  Changes Before Treatment and 1 month after treatment

• Alzheimer's Disease Assessment Scale

  Cognitive Neuropsychological Test Score

  Changes Before Treatment and 1 month after treatment

• ADSL

  Cognitive Neuropsychological Test Score

  Changes Before Treatment and 1 month after treatment

• Geriatric Depression Scale

  Cognitive Neuropsychological Test Score

  Changes Before Treatment and 1 month after treatment

Secondary Outcomes (8)

• Blood samples ELISA analyses

  Changes Before Treatment and 1 month after treatment

• Blood samples analyses

  Changes Before Treatment and 1 month after treatment

• Inflammatory Biomarker analyses

  Changes Before Treatment and 1 month after treatment

• Oxidative Stress Biomarker analyses

  Changes Before Treatment and 1 month after treatment

• Evaluation of Fatty Acid Profile Analysis with GC-MS

  Changes Before Treatment and 1 month after treatment

Study Arms (2)

Interventional

EXPERIMENTAL

Power Mag TMS device will be used throughout the study, and the excitations will be made with the help of an 8 shaped coil (diameter: 70 mm) with internal cooling. The right-left DLPFC, which is the application area, will be determined with the help of the primary motor hand area and the 10/20 EEG system. A resting state EEG (eyes open-closed) will be taken i in the Faraday cage.

Device: Repetetive Transcranial Magnetic Stimulation

Sham

SHAM COMPARATOR

The same treatment procedures will be applied to the control group with a sham coil.

Device: Repetetive Transcranial Magnetic Stimulation

Interventions

Repetetive Transcranial Magnetic Stimulation DEVICE

.Power Mag TMS device will be used throughout the study, and the excitations will be made with the help of an 8 shaped coil (diameter: 70 mm) with internal cooling. The right-left DLPFC, which is the application area, will be determined with the help of the primary motor hand area and the 10/20 EEG system. A resting state EEG (eyes open-closed) will be taken in the Faraday cage. The same procedures will be done with the sham coil in the control group.

Also known as: Electroensefolography

Interventional; Sham

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have been diagnosed with clinical Alzheimer's Disease in accordance with the NINCDS-ADRDA diagnostic criteria
• \>55 years old
• Clinical Dementia Rating Scale (CDR) score in the 1-2 range
• Not having any other disease that affects their cognitive functions
• Volunteer to participate in the study

You may not qualify if:

• Participant or relative does not give consent
• The patient's inability to participate in the entire study procedure (eg living in another city)
• The patient's history of head trauma with alcohol/substance abuse
• Presence of severe stroke and other neurological sequelae disease in the participant
• Presence of a metal implant on the head or having a pacemaker and contraindications for other TMS applications During the study or 1 month before, having/been receiving/receiving an investigational drug targeting Alzheimer's disease or neuromodulation treatment such as tDCS and TMS, other than standard treatment for AD symptom control such as acetylcholine esterase and memantine, with the potential to affect the study

Sponsors & Collaborators

• Istanbul Medipol University Hospital: lead
• Bezmialem Vakif University: collaborator
• Saglik Bilimleri Universitesi: collaborator

Study Sites (1)

Medipol University Hospital

Istanbul, 34214, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Lutfu Hanoglu, Prof. DR. MD

  Medipol University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lutfu Hanoglu, Prof. DR. MD

CONTACT

+90 444 8 544; lhanoglu@kure.com.tr

Cennet Sena Parlatan, PhD Cand

CONTACT

05077799164; cennetsenaparlatan@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof Dr MD

Study Record Dates

• First Submitted: June 2, 2023
• First Posted: August 4, 2023
• Study Start: February 16, 2022
• Primary Completion: May 15, 2025
• Study Completion: December 30, 2025
• Last Updated: May 2, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)