Transcranial Magnetic Stimulation in Patients With Mild Cognitive Impairment - RCT Trial

NCT ID: NCT05730296

Last Updated: 2023-02-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-01
• Study Completion Date: 2024-12-30

Brief Summary

The study is planned as a randomized, double-blind, and sham-controlled parallel trial, in which raters and participants will be blinded to the group selection. A total of 60 participants, meeting the eligibility criteria, will be enrolled in the study and divided randomly into 3 groups (2 experimental ones with active rTMS, one of which with the addition of cognitive training RehaCom, one control group with sham-placebo rTMS).

Detailed Description

The study is planned as a randomized, double-blind, and sham-controlled parallel trial, in which raters and participants will be blinded to the group selection. A total of 60 participants, meeting the eligibility criteria, will be enrolled in the study and divided randomly into 3 groups (2 experimental ones with active rTMS, with and without the addition of cognitive training RehaCom, one control group with sham-placebo rTMS).

Experimental group 1 (E1, n=20): patients undergoing rTMS and computerized cognitive training Experimental group 2 (E2, n=20) patients undergoing TMS without training of cognitive function Control group (CG, n=20) - patients with placebo TMS - sham coil without cognitive training

The following stimulation protocol will be used to conduct research into the treatment of mild cognitive impairment.

The target area in rTMS is the dorsolateral prefrontal cortex of the left hemisphere of the brain, mostly responsible for operational memory, memory of everyday events, information processing and learning. Delivering rTMS protocol is characterized by two thousand pulses at 10 Hz, 5-s train duration, and 25-seconds intervals at 110% of motor threshold five times a week for two weeks. The following protocol has been chosen based on reports from the article by Hellen Livia Drumond et at. (2015). In this study the research group has demonstrated that after 10 sessions of active TMS (two thousand pulses at 10 Hz, 5-s train duration, and 25-seconds intervals at 110% of motor threshold five times a week for two weeks) crucial for MCI cognitive domains such as episodic memory and logical memory.

Conditions

Mild Cognitive Impairment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

group 1

rTMS active + training

Group Type: EXPERIMENTAL

TMS

Intervention Type: DEVICE

10 rTMS sessions combined with cognitive training

group 2

rTMS active

Group Type: EXPERIMENTAL

TMS

Intervention Type: DEVICE

10 rTMS sessions

sham coil

rTMS sham

Group Type: SHAM_COMPARATOR

TMS

Intervention Type: DEVICE

10 sham coils sessions without cognitive training

Interventions

TMS

10 rTMS sessions combined with cognitive training

Intervention Type: DEVICE

TMS

10 rTMS sessions

Intervention Type: DEVICE

TMS

10 sham coils sessions without cognitive training

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• participants of both sexes with MCI
• informed consent to undergo rTMS and study protocol

Screening procedure of cognitive deficits:

• confirmation of the diagnosis of MCI according to Petersen's criteria (concern related to the change in cognitive performance, deterioration in one or more cognitive areas, maintaining the independent ability of daily functioning, lack of dementia)
• confirmation of the diagnosis of MCI based on the results obtained in neuropsychological tests (MoCA, Montreal Cognitive Assessment test and CDR, Clinical Dementia Rate)

Exclusion Criteria

Contraindications to treatments using TMS:

• positive history of epileptic seizures or a positive family history of epilepsy
• magnetic or ferromagnetic implants, both electronic (e.g., heart/brain stimulators) as well as mechanical (eg bone anastomoses) within the head and neck
• previous stroke or head injury with identified neurological deficits
• increased intracranial pressure or a positive history of increased intracranial pressure
• pregnant women and women during lactation

Contraindications to MR examinations:

• claustrophobia
• magnetic or ferromagnetic implants, both electronic (e.g., cardiac/brain stimulators) as well as mechanical (eg bone anastomoses) within the head and neck
• other psychiatric disorders (i.e. depression, anxiety disorders), which may affect cognitive performance (GDS-15, 15-Item Geriatric Depression Scale; HAMA-14, 14-Item Hamilton Anxiety Scale)
• braces
• occurrence of significant pathologies in the cerebrum area (tumors, hydrocephalus, strokes)
• lack of patient's informed consent
• documented persistent lack of cooperation in treatment

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wroclaw Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joanna Rymaszewska, Professor

Role: STUDY_DIRECTOR

Wroclaw Medical Univeristy, Department of Psychiatry

Locations

Wroclaw Medical University, Department of Psychiatry

Wroclaw, Lower Silesian Voivodeship, Poland

Site Status: RECRUITING

Countries

Poland

Central Contacts

Senczyszyn

Role: CONTACT

adrianna.senczyszyn@student.umed.wroc.pl

+48 600805491

Other Identifiers

SUBZ.C230.22.062.TMS.MCI

Identifier Type: -

Identifier Source: org_study_id