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

Wroclaw Medical University

Status: Enrolling

Conditions: Mild Cognitive Impairment

Treatments: Device: TMS

Study type: Interventional

Funder types: Other

Identifiers

NCT05730296

SUBZ.C230.22.062.TMS.MCI

Details and patient eligibility

About

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).

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 55 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Detailed 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)

Detailed exclusion criteria (TMS and fMRI)

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 3 patient groups

group 1

Experimental group

Description:

rTMS active + training

Treatment:

Device: TMS

Device: TMS

Device: TMS

group 2

Experimental group

Description:

rTMS active

Treatment:

Device: TMS

Device: TMS

Device: TMS

sham coil

Sham Comparator group

Description:

rTMS sham

Treatment:

Device: TMS

Device: TMS

Device: TMS