Mild Cognitive ImpairmentNCT05730296
Transcranial Magnetic Stimulation in Patients With Mild Cognitive Impairment - RCT Trial
A study testing TMS in people with Mild Cognitive Impairment, run by Wroclaw Medical University at 1 site in Poland.
Trial 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… Read more about this study
- Who is it for?
- Ages 55 to 85 years
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- TMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jan 2019to 30 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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 locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Wroclaw Medical University, Department of Psychiatry
Wroclaw, Lower Silesian Voivodeship, 50-367
About this study
Official title: 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).
Read the 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
- Being tested
- TMS
- Keywords
- rTMS, MCI, TMS, RCT
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TMSDevice
10 rTMS sessions combined with cognitive training
TMSDevice
10 rTMS sessions
TMSDevice
10 sham coils sessions without cognitive training
| Study group | Role | What they receive |
|---|---|---|
| group 1 | Experimental | rTMS active + training Receives: Device: TMS |
| group 2 | Experimental | rTMS active Receives: Device: TMS |
| sham coil | Sham comparator | rTMS sham Receives: Device: TMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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).
Measured: 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
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).
Measured: 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.
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.
Measured: 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.
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.
Measured: END of stimulation
Secondary outcomes (1)
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.
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.
Measured: END of stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2023
- Study start1 Jan 2019
- Primary completion30 Dec 2023 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wroclaw Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joanna Rymaszewska, Professor, Study director, Wroclaw Medical Univeristy, Department of Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05730296
- Sponsor's protocol ID
- SUBZ.C230.22.062.TMS.MCI
- Status last verified
- Feb 2023
- First submitted
- 6 Feb 2023
- Last updated
- 15 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Repetitive Transcranial Magnetic Stimulation in Older Adults With Mild Cognitive Impairment - Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05730296
- Acronym / sponsor ID
- SUBZ.C230.22.062.TMS.MCI
- Conditions
- Mild Cognitive Impairment
- Keywords
- rTMS, MCI, TMS, RCT
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Wroclaw Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 15 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| group 1 | Experimental | Device: TMSrTMS active + training |
| group 2 | Experimental | Device: TMSrTMS active |
| sham coil | Sham comparator | Device: TMSrTMS sham |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TMS10 rTMS sessions combined with cognitive training | Device | group 1 |
| TMS10 rTMS sessions | Device | group 2 |
| TMS10 sham coils sessions without cognitive training | Device | sham coil |
Primary outcome
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).
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 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.
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joanna Rymaszewska, Professor study director
Wroclaw Medical Univeristy, Department of Psychiatry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TMS in people with Mild Cognitive Impairment, run by Wroclaw Medical University at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Senczyszyn (+48 600805491, adrianna.senczyszyn@student.umed.wroc.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2023; AzTrials last refreshed its copy on 7 Nov 2026.