Assessment of Effectiveness and Safety of Transcranial Magnetic Stimulation (rTMS) Combined With Transcranial Direct Current Stimulation (tDCS) in Dementia Treatment in Alzheimer's Disease

NCT04823819 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2021-05-27

No results posted yet for this study

Summary

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.

Conditions

  • Alzheimer Disease

Interventions

DEVICE

Magnetic Stimulator DuoMag

Stimulation of the left dorsolateral prefrontal cortex

DEVICE

neuroConn DC-STIMULATOR

One electrode (anode) will be placed on the left dorsolateral prefrontal cortex, the other (cathode) on the right temporal lobe.

Sponsors & Collaborators

  • Medical University of Lodz

    lead OTHER

Principal Investigators

  • Jakub Kazmierski, PhD · Medical University of Lodz, Poland

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-01
Primary Completion
2023-09-30
Completion
2023-09-30

Countries

  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04823819 on ClinicalTrials.gov