NCT05730296

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

The Effects of Repetitive Transcranial Magnetic Stimulation in Older Adults With Mild Cognitive Impairment - Randomized Controlled Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Wroclaw Medical University · Academic / Other
• Sex: All
• Age: 55 Years – 85 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	TMS	10 rTMS sessions combined with cognitive training
DEVICE	TMS	10 rTMS sessions
DEVICE	TMS	10 sham coils sessions without cognitive training

Timeline

• Start date: 2019-01-01
• Primary completion: 2023-12-30
• Completion: 2024-12-30
• First posted: 2023-02-15
• Last updated: 2023-02-15

Locations

1 site across 1 country: Poland