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

February 6, 2023 updated by: Wroclaw Medical University

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
    • Dolnośląskie
      • Wrocław, Dolnośląskie, Poland, 50-367
        • Recruiting
        • Wroclaw Medical University, Department of Psychiatry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: group 1
rTMS active + training
Device: TMS
10 rTMS sessions combined with cognitive training
Device: TMS
10 rTMS sessions
Device: TMS
10 sham coils sessions without cognitive training
Experimental: group 2
rTMS active
Device: TMS
10 rTMS sessions combined with cognitive training
Device: TMS
10 rTMS sessions
Device: TMS
10 sham coils sessions without cognitive training
Sham Comparator: sham coil
rTMS sham
Device: TMS
10 rTMS sessions combined with cognitive training
Device: TMS
10 rTMS sessions
Device: TMS
10 sham coils sessions without cognitive training

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
END of stimulation
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).
END of stimulation
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.
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.
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.
END of stimulation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: END of stimulation
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 Apathy Evaluation Scale.
END of stimulation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wroclaw Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2019

Primary Completion (Anticipated)

December 30, 2023

Study Completion (Anticipated)

December 30, 2024

Study Registration Dates

First Submitted

February 6, 2023

First Submitted That Met QC Criteria

February 6, 2023

First Posted (Actual)

February 15, 2023

Study Record Updates

Last Update Posted (Actual)

February 15, 2023

Last Update Submitted That Met QC Criteria

February 6, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SUBZ.C230.22.062.TMS.MCI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Mild Cognitive Impairment

Clinical Trials on TMS

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Macedonia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe