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

Alzheimer Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04823819
• Other study ID #: RNN/246/20/KE
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2021
• Est. completion date: September 30, 2023

Study information

• Verified date: May 2021
• Source: Medical University of Lodz
• Contact: Emilia Frankowska
• Phone: 0048781927677
• Email: emilia.mielczarek1[@]stud.umed.lodz.pl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: September 30, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Dementia

Intervention

Device:
• Magnetic Stimulator DuoMag
Stimulation of the left dorsolateral prefrontal cortex
• neuroConn DC-STIMULATOR
One electrode (anode) will be placed on the left dorsolateral prefrontal cortex, the other (cathode) on the right temporal lobe.

Locations

Country	Name	City	State
Poland	Department of Old Age Psychiatry and Psychotic Disorders Medical University of Lodz	Lodz

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Lodz

Country where clinical trial is conducted

Poland, 

Outcome

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