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

May 25, 2021 updated by: Jakub Kazmierski, Medical University of Lodz

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Poland
      • Lodz, Poland, 92-213
        • Recruiting
        • Department of Old Age Psychiatry and Psychotic Disorders Medical University of Lodz
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with mild to moderate dementia in Alzheimer's disease, diagnosed using DSM-5 criteria.
  • MMSE score from 12 to 26 points
  • ADAS-Cog over 17 points
  • Voluntary consent to participate in the study
  • there is a related person or legal guardian who consented to assist the patient in the course of the study
  • Minimum 8 years of education.
  • It is allowed to use cholinesterase inhibitors and / or memantine for at least 3 months prior to study entry and at a stable dose for at least 60 days prior to study entry.

Exclusion Criteria:

  • Severe agitation
  • Intellectual Disability
  • Informed consent is not possible
  • Unstable somatic condition
  • Use of benzodiazepines or barbiturates 2 weeks prior to screening
  • Participation in a clinical trial with coinciding factors within 6 months prior to the start of the trial
  • Seizures
  • Contraindications to rTMS treatment according to the rTMS questionnaire attached to the protocol
  • Contraindications to tDCS treatment according to the tDCS questionnaire attached to the protocol
  • Patients with depression, bipolar, or psychotic disorders, or any other neurological or psychiatric condition (current or past) that the Investigator considers to be interfering with the study
  • Alcoholism or drug addiction as defined by DSM-5 in the last 5 years (addicted for more than a year and or in remission for less than 3 years)
  • Patients with any medical condition that the Investigator considers to be an exclusion criterion from the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: rTMS stimulation
20 sessions of stimulation with increasing intensity, reaching maximum in the 4th session.
Device: Magnetic Stimulator DuoMag
Stimulation of the left dorsolateral prefrontal cortex
ACTIVE_COMPARATOR: tDCS stimulation
The stimulation time will be 20 minutes, the current intensity will be 2mA.
Device: neuroConn DC-STIMULATOR
One electrode (anode) will be placed on the left dorsolateral prefrontal cortex, the other (cathode) on the right temporal lobe.
SHAM_COMPARATOR: Sham rTMS stimulation
20 sessions of stimulation, but without current.
Device: Magnetic Stimulator DuoMag
Stimulation of the left dorsolateral prefrontal cortex
SHAM_COMPARATOR: Sham tDCS stimulation
The stimulation time will be 20 minutes, but without current.
Device: neuroConn DC-STIMULATOR
One electrode (anode) will be placed on the left dorsolateral prefrontal cortex, the other (cathode) on the right temporal lobe.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MMSE Scale
Time Frame: up to 12 weeks
Assessment conducted on baseline, up to 1 week after end of the procedure and after 12 weeks.
up to 12 weeks
ADAS-Cog Scale
Time Frame: up to 12 weeks
Assessment conducted on baseline, up to 1 week after end of the procedure and after 12 weeks.
up to 12 weeks
NPI Scale
Time Frame: up to 12 weeks
Assessment conducted on baseline, up to 1 week after end of the procedure and after 12 weeks.
up to 12 weeks
ADCS
Time Frame: up to 12 weeks
Assessment conducted on baseline, up to 1 week after end of the procedure and after 12 weeks.
up to 12 weeks
GDS
Time Frame: up to 12 weeks
Assessment conducted on baseline, up to 1 week after end of the procedure and after 12 weeks.
up to 12 weeks
Zarit Burden Interview
Time Frame: up to 12 weeks
Assessment conducted on baseline, up to 1 week after end of the procedure and after 12 weeks.
up to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Lodz

Investigators

  • Principal Investigator: Jakub Kazmierski, PhD, Medical University of Lodz, Poland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 1, 2021

Primary Completion (ANTICIPATED)

September 30, 2023

Study Completion (ANTICIPATED)

September 30, 2023

Study Registration Dates

First Submitted

March 26, 2021

First Submitted That Met QC Criteria

March 26, 2021

First Posted (ACTUAL)

April 1, 2021

Study Record Updates

Last Update Posted (ACTUAL)

May 27, 2021

Last Update Submitted That Met QC Criteria

May 25, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RNN/246/20/KE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Alzheimer Disease

Clinical Trials on Magnetic Stimulator DuoMag

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Turkmenistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe