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Alzheimer's disease is the most common disease responsible for dementia, accounting for 40-70% of all dementia cases. Alzheimer's disease is characterized by a gradual and slow decline in memory and other cognitive functions and activities.
The medications currently used in Alzheimer's disease were introduced in the 1990s and exhibit insufficient effectiveness. Despite their use, the disease rapidly progresses, leading to complete loss of independence and death. There are conducted numerous studies on new molecules, however none of them has been successfully accomplished so far. Transcranial magnetic stimulation (TMS) is one of the youngest electrophysiological methods, enabling non-invasive and painless stimulation of the central and peripheral nervous system. Another non-invasible neurophysiological method that is utilized in treating patients with neurological dysfunctions and mental disorders is Transcranial direct current stimulation (tDCS). Clinical trials conducted with isolated usage of rTMS and tDCS showed a positive effect of these methods on the enhancement of cognitive functions in patients with Alzheimer's disease.
The aim of the project is to evaluate the effectiveness and safety of the combination of Repetitive Transcranial Magnetic Resonance (rTMS) with Transcranial direct current stimulation in the treatment of Alzheimer's dementia. The primary goal of the project is to assess whether the use of combined tDCS and rTMS therapies in patients diagnosed with mild to moderate Alzheimer's disease improves patients' cognitive functions, including memory, attention, thinking, executive and language functions. The research hypothesis assumes that the combination of rTMS and tDCS therapy is an effective method of Alzheimer's disease therapy that can improve cognitive functions and functioning of patients, both in the short and long term.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| rTMS stimulation | Active Comparator | 20 sessions of stimulation with increasing intensity, reaching maximum in the 4th session. |
|
| tDCS stimulation | Active Comparator | The stimulation time will be 20 minutes, the current intensity will be 2mA. |
|
| Sham rTMS stimulation | Sham Comparator | 20 sessions of stimulation, but without current. |
|
| Sham tDCS stimulation | Sham Comparator | The stimulation time will be 20 minutes, but without current. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnetic Stimulator DuoMag | Device | Stimulation of the left dorsolateral prefrontal cortex |
|
| Measure | Description | Time Frame |
|---|---|---|
| MMSE Scale | Assessment conducted on baseline, up to 1 week after end of the procedure and after 12 weeks. | up to 12 weeks |
| ADAS-Cog Scale | Assessment conducted on baseline, up to 1 week after end of the procedure and after 12 weeks. | up to 12 weeks |
| NPI Scale | Assessment conducted on baseline, up to 1 week after end of the procedure and after 12 weeks. | up to 12 weeks |
| ADCS | Assessment conducted on baseline, up to 1 week after end of the procedure and after 12 weeks. | up to 12 weeks |
| GDS | Assessment conducted on baseline, up to 1 week after end of the procedure and after 12 weeks. | up to 12 weeks |
| Zarit Burden Interview | Assessment conducted on baseline, up to 1 week after end of the procedure and after 12 weeks. | up to 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Emilia Frankowska | Contact | 0048781927677 | emilia.mielczarek1@stud.umed.lodz.pl |
| Name | Affiliation | Role |
|---|---|---|
| Jakub Kazmierski, PhD | Medical University of Lodz, Poland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Old Age Psychiatry and Psychotic Disorders Medical University of Lodz | Recruiting | Lodz | 92-213 | Poland |
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| neuroConn DC-STIMULATOR | Device | One electrode (anode) will be placed on the left dorsolateral prefrontal cortex, the other (cathode) on the right temporal lobe. |
|
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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