The Effects of Repetitive Transcranial Magnetic Stimulation in Older Adults With Mild Cognitive Impairment - Randomized Controlled Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Mild Cognitive Impairment
- Sponsor
- Wroclaw Medical University
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Comparison of efficiency of rTMS active and sham-placebo stimulation Change from baseline to END of stimulation regarded as reduction of symptoms of cognitive disorders measured by DemTect test.
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Comparison of efficiency of rTMS active and sham-placebo stimulation Change from baseline to END of stimulation regarded as reduction of symptoms of cognitive disorders measured by DemTect test.
Time Frame: END of stimulation
Comparison of efficiency of rTMS active and rTMS sham placebo stimulation from baseline to end of stimulation measured by DemTect scale. DemTect is a screening test for MCI and early stages of dementia, especially sensitive to memory deficits. The whole test consists of 5 subscales: (1) a word list, (2) number transcoding, (3) supermarket (semantic fluency), (4) digit span reverse and (5) word list delayed recall.
Comparison of efficiency of rTMS active and rTMS sham placebo stimulation from baseline to end of stimulation measured by neuroimaging parameters derived from volumetry, DTI and rs fMRI.
Time Frame: END of stimulation
Comparison of efficiency of rTMS active and rTMS sham placebo stimulation from baseline to end of stimulation measured by neuroimaging parameters derived from volumetry, DTI and rs fMRI. Brain MRI will be performed with a 3 Tesla (Ingenia, Philips Best) scanner using standard anatomical sequences include the following high resolution sequences: 3D T1-weighted, 3D-T2-weighted, 3D Flair and post gadolinium 3DT1-weighted imaging followed by new advanced techniques such as brain volumetry, DTI and rs-fMRI. All participants will undergo brain standard MR imaging using a 32-channel coil dedicated for head examination before and after rTMS.
Comparison of efficiency of rTMS active and sham-placebo stimulation Change from baseline to END of stimulation regarded as reduction of symptoms of cognitive disorders measured by FAS test
Time Frame: END of stimulation
Comparison of efficiency of rTMS active and rTMS sham placebo stimulation from baseline to end of stimulation measured by verbal fluency FAS test. Verbal fluency is measured by requesting an individual to orally produce as many words as possible that begin with the letters F, A, and S within a prescribed time frame (1 minute in the research).
Comparison of efficiency of rTMS active and sham-placebo stimulation Change from baseline to END of stimulation regarded as reduction of symptoms of cognitive disorders measured by CANTAB test
Time Frame: END of stimulation
Comparison of efficiency of rTMS active and rTMS sham placebo stimulation from baseline to end of stimulation measured with The Cambridge Neuropsychological Test Automated Battery (CANTAB). The CANTAB includes highly sensitive, precise and objective measures of cognitive function, correlated to neural networks with demonstrated sensitivity to detecting changes in neuropsychological performance. The battery includes tests of working memory, learning and executive function; visual, verbal and episodic memory; attention, information processing and reaction time; social and emotion recognition, decision making and response control.Cognitive performance testing using selected CANTAB will examine: attention (Reaction Time test), visual memory (Paired Association Learning, Pattern Recognition Memory), executive functions and operating memory (Spatial Working Memory).
Secondary Outcomes
- Comparison of efficiency of rTMS active and sham-placebo stimulation Change from baseline to END of stimulation regarded as reduction of symptoms of apathy measured by AES scale.(END of stimulation)