Mild Cognitive ImpairmentNCT04490616
TMS Treatment of Social Cognition Skills in Mild Cognitive Impairment
A study testing rTMS treatment in people with Mild Cognitive Impairment, run by Ospedale Regionale di Lugano at 1 site in Switzerland.
Trial summary
Social cognitive abilities are impaired in around 17% of subjects with mild cognitive impairment (MCI), and might not reflect upon functional status. Compared to healthy controls, MCI showed impairments in theory of mind (ToM) and facial emotion recognition. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- rTMS treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteSwitzerland
- Study dates
- 11 Feb 2021to 31 Mar 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects aged 50 to 85 years old, inclusive, at the time of informed consent;
- Must have at least 5 years of education or work experience to exclude mental deficits other than MCI;
- Must meet Petersen's criteria for mild cognitive impairment, and must have:
- Clinical dementia rating global score of 0.5;
- Mini-Mental State Examination score between 24 and 30;
- Must have a score ≥ 26.5 at Token test to ensure that subjects have the ability to understand the instructions and procedures;
Show all 9Show fewer
- Must have a score < 29 at Beck Depression Inventory to exclude major depression that could compromise the patient's ability to engage in the study;
- Apart from a clinical diagnosis of MCI, the subject must be in good health;
- Must be on stable dose of antidepressant (if applicable) for at least 2 months prior to the enrolment.
Who cannot join
- Any uncontrolled medical or neurological/neurodegenerative condition (other than MCI);
- Clinical significant unstable psychiatric illness requiring treatment with neuroleptic;
- Transient ischemic attack, stroke, or any unexplained loss of consciousness or severe ongoing stressor within 1 year prior to screening;
- History of seizure within10 years prior to screening;
- Recent history of alcohol or substance abuse or use of cannabinoids;
- Any other medical conditions that are not stable or controlled, or could affect the subject's safety or interfere with the study assessments and treatment;
- Contraindication to having TMS treatment;
- Inability to understand the purpose of the study or to comply with study requirements.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Neurocentro della Svizzera italiana,Ospedale Regionale di Lugano
Lugano, Canton Ticino, 6903
About this study
Official title: EFFECTS OF rTMS TREATMENT ON SOCIAL COGNITION DYSFUNCTIONS IN MILD COGNITIVE IMPAIRMENT: AN PROSPECTIVE, DOUBLE-BINDING, RANDOMIZED, SINGLE CENTRE, EXPLORATIVE STUDY
Social cognitive abilities are impaired in around 17% of subjects with mild cognitive impairment (MCI), and might not reflect upon functional status. Compared to healthy controls, MCI showed impairments in theory of mind (ToM) and facial emotion recognition. Moreover, in amnesic MCI patients, reduced ToM ability appears to be correlated with worse performances at several cognitive performances. These findings, in agreement with previous evidence, confirm that impaired social cognition might occur prior to dementia: typically elderly start to show impairment in the complex ToM levels, which is found also in MCI patients and proceeds further in AD patients. Thus, the treatment of these aspects has the potential to influence the trajectory of neurodegeneration. In the last decade, it has been increasingly evident the effectiveness of active stimulation of brain regions with repetitive transcranial magnetic stimulation (rTMS), to improve cognitive and functional performances in patients with dementia.
On the other hand, brain imaging techniques and TMS stimulations have identified two main areas responsible for human social cognition- the medial prefrontal cortex (MPFC) and the right temporo-parietal junction (RTPJ).
In this project, we hypothesized that an improvement of social cognition skills may be obtained in MCI patients by using the rTMS on two main areas responsible for human social cognition- the medial prefrontal cortex (MPFC) and the right temporoparietal junction (RTPJ). Moreover, it expects that rTMS treatment may also contribute to improving cognitive abilities and neuropsychiatric aspects partially modulated by the same networks stimulated.
Read the detailed description
This is a prospective, double-binding, cross-sectional, randomized, sham-controlled, and single-center project aimed to investigate the effect of rTMS treatment of social cognition abilities in MCI subjects at 2 and 4 weeks, and after 8 weeks from baseline.
All patients will be recruited at Clinical Neuroscience Institute, Department of Neurology, Regional Civic Hospital, Lugan; Department of Geriatric Italian Hospital Viganello; and Department of Geriatric, Beata Vergine Hospital Mendrisio; Southern Switzerland, Switzerland.
Primary objective:
- To investigate whether the application of high-frequency rTMS, for 2 or 4 weeks, to the RPTJ and MPFC resulted in social cognitive improvements.
Secondary objectives:
- To verify whether the social cognition benefits previously recorded might persist after 8 weeks the end of the stimulation, with a major benefit with a longer rTMS application (4 weeks).
- To investigate whether the application of high-frequency rTMS, at 2 weeks or 4 weeks, to the RPTJ and MPFC contributes to improve cognitive functions as well as neuropsychiatric (depression) and functional aspects.
- To verify whether the cognitive functions, neuropsychiatric aspect, and functional benefits previously recorded persist after the end of the rTMS stimulation.
Primary analysis: To investigate the behavioral effects induced by the rTMS protocol after 2 and 4 weeks of daily stimulation on social cognition skills, executive/attentive functions, neuropsychiatric and functional aspects will be used a mixed-model ANOVA, considering the group as a between-subjects factor, and time as a within-subject factor.
Secondary Analyses: To investigate the direct or mediated rTMS effect on social cognition skills, a multivariate linear regression analysis will be done for each social cognition measure (ToM, empathy, social perception, social behavior) changes after rTMS treatment at 2 and 4 weeks as the dependent factor, separately, and appropriate screening/baseline dependent variables and rTMS groups as independent factors.
The evaluation and treatment of social cognition alterations in subjects with MCI can be useful for two main aspects: first, the mild cognitive and behavior impairment of these subjects favor a better answer at the treatment, both at the behavioral level and in terms of brain structural and functional response; second, treatment of these abilities in MCI population might retard the conversion to dementia. More importantly, the detection of predominant social cognition alteration in early phases of cognitive decline might be potentially helpful to differentiate individuals who will develop frontotemporal dementia. Therefore, it is important to investigate and define a treatment protocol to limit social cognition disturbances in MCI.
- Conditions
- Mild Cognitive Impairment
- Being tested
- rTMS treatment
- Keywords
- ripetitive transcranial magnetic stimulation treatment, social cognition, theory of mind, empathy, social perception, social behavior
- Medical subject headings
- Cognitive Dysfunction, Social Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rTMS treatmentOther
A two-site rTMS stimulation delivered by a Magstim unit featuring a double 70 mm cooled coil will be applied.
MCI patients will be randomly assigned to one of the two study groups:
- RR-Gr will receive 4 weeks of rTMS stimulation of the right temporo-parietal junction (RTPJ) and medial prefrontal cortex (MPFC);
- PL-Gr will receive sham stimulation of the RTPJ and MPFC during the first 2 weeks followed by 2 weeks of real stimulation. Each week of rTMS treatment will consist of five sessions (50 min, one per day).
For each area target, a total of 2000 pulses at 20Hz, 3-s train duration, and 28-s inter-train interval at 100% motor threshold (MT) will be delivered per session. A fixed intensity of MT will ensure a more consistent spatial spread of TMS effects in subjects' brains not influenced by differences in individual MT. In the sham condition, a sham coil will be used.
Each session lasted for about 60 min including time for set up and 50 min of stimulation.
| Study group | Role | What they receive |
|---|---|---|
| RR-GR | Experimental | MCI patients with social cognition deficits will receive 4 weeks of rTMS stimulation Receives: Other: rTMS treatment |
| SR-GR | Other | MCI patients with social cognition deficits will receive 2 weeks of placebo treatment, followed by 2 weeks of real rTMS stimulation Receives: Other: rTMS treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of Deceptive Box Task score
(5 items). Minimum value=0, maximum value=5. A higher score means a better outcome.
Measured: Week 2
Comparison of Look-prediction/say-prediction test score
(5 items). Minimum value=0, maximum value=5. A higher score means a better outcome.
Measured: Week 2
Comparison of Empathy Quotient score
(60 items). Minimum value=0, maximum value=80. A higher score means a better outcome.
Measured: Week 2
Comparison of Ekman 60 test score
(60 b/w pictures). Minimum value=0, maximum value=60. Higher score means a better outcome.
Measured: Week 2
Comparison of Frontal Behavioral Inventory score
(24 items). Minimum value=0, maximum value=69. Higher score means a worse outcome.
Measured: Week 2
Comparison of Deceptive Box Task score
(5 items). Minimum value=0, maximum value=5. A higher score means a better outcome.
Measured: Week 4
Comparison of Look-prediction/say-prediction test
(5 items). Minimum value=0, maximum value=5. A higher score means a better outcome.
Measured: Week 4
Comparison of Empathy Quotient score
(60 items). Minimum value=0, maximum value=80. A higher score means a better outcome.
Measured: Week 4
Comparison of Ekman 60 test score
(60 b/w pictures). Minimum value=0, maximum value=60. Higher score means a better outcome.
Measured: Week 4
Comparison of Frontal Behavioral Inventory score
(24 items). Minimum value=0, maximum value=69. Higher score means a worse outcome.
Measured: Week 4
Secondary outcomes (8)
Changes from baseline in Deceptive Box Task Test.
(5 items). Minimum value=0, maximum value=5. A higher score means a better outcome.
Measured: Week 12
Changes from baseline in Look/say Test
(5 items). Minimum value=0, maximum value=5. A higher score means a better outcome.
Measured: Week 12
Changes from baseline in Empathy Quotient scale
(60 items). Minimum value=0, maximum value=80. A higher score means a better outcome.
Measured: Week 12
Changes from baseline in Ekman 60 Test
(60 b/w pictures). Minimum value=0, maximum value=60. Higher score means a better outcome.
Measured: Week 12
Changes from baseline in Frontal Behavioral Inventory
(24 items). Minimum value=0, maximum value=69. Higher score means a worse outcome.
Measured: Week 12
Comparison Montreal Cognitive Assessment
(30 items). Minimum value=0, maximum value=30. Higher score means a better outcome.
Measured: through study completion, an average of 12 weeks
Comparison of Geriatric Depression Scale score
(30 items). Minimum value=0, maximum value=30. Higher score means a better outcome.
Measured: through study completion, an average of 12 weeks
Comparison of Euroquol-5 dimensions score
(visual analogue scale with 100-point scale). Minimum value=0, maximum value=100. Higher score means a better outcome.
Measured: athrough study completion, an average of 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2020
- Study start11 Feb 2021
- Primary completion28 Feb 2024
- Study completion31 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- 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
- Crossover
- Model description
- In the project will be applied a two-site repetitive transcranial magnetic stimulation (rTMS) stimulation. MCI patients that obtained a score ≤ 10 percentiles, at least one performance/domain of social cognition assessment will be considered impaired at social cognition abilities. In the same day of cognitive-behavioral assessment, patients will be randomly assigned to one of the two groups: 1\) RR-Gr received 4 weeks of rTMS stimulation of the RTPJ and MPFC; (2) SR-Gr received of the RTPJ and MPFC sham stimulation during the first 2 weeks followed by 2 weeks of real stimulation. Each week of rTMS treatment consisted of five sessions. This paradigm has proven to be effective for improve cognitive performances in AD patients. In the sham condition, a sham coil will be used.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ospedale Regionale di Lugano
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leonardo Sacco, Ospedale Regionale di Lugano
- Investigators
- Leonardo Sacco, Dr, Principal investigator, +41 091 811 6921
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04490616
- Sponsor's protocol ID
- 2020-00434/CE 3594
- Status last verified
- Oct 2023
- First submitted
- 10 Jul 2020
- Last updated
- 20 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Freedman M, Binns MA, Black SE, Murphy C, Stuss DT. Theory of mind and recognition of facial emotion in dementia: challenge to current concepts. Alzheimer Dis Assoc Disord. 2013 Jan-Mar;27(1):56-61. doi: 10.1097/WAD.0b013e31824ea5db.
PubMed 22407224Adolphs R. The social brain: neural basis of social knowledge. Annu Rev Psychol. 2009;60:693-716. doi: 10.1146/annurev.psych.60.110707.163514.
PubMed 18771388Wondra JD, Ellsworth PC. An appraisal theory of empathy and other vicarious emotional experiences. Psychol Rev. 2015 Jul;122(3):411-28. doi: 10.1037/a0039252. Epub 2015 May 11.
PubMed 25961468Apperly IA, Samson D, Chiavarino C, Humphreys GW. Frontal and temporo-parietal lobe contributions to theory of mind: neuropsychological evidence from a false-belief task with reduced language and executive demands. J Cogn Neurosci. 2004 Dec;16(10):1773-84. doi: 10.1162/0898929042947928.
PubMed 15701227Wood JN, Knutson KM, Grafman J. Psychological structure and neural correlates of event knowledge. Cereb Cortex. 2005 Aug;15(8):1155-61. doi: 10.1093/cercor/bhh215. Epub 2004 Nov 24.
PubMed 15563720Van Overwalle F. Social cognition and the brain: a meta-analysis. Hum Brain Mapp. 2009 Mar;30(3):829-58. doi: 10.1002/hbm.20547.
PubMed 18381770Amodio DM, Frith CD. Meeting of minds: the medial frontal cortex and social cognition. Nat Rev Neurosci. 2006 Apr;7(4):268-77. doi: 10.1038/nrn1884.
PubMed 16552413Cabeza R, Ciaramelli E, Moscovitch M. Cognitive contributions of the ventral parietal cortex: an integrative theoretical account. Trends Cogn Sci. 2012 Jun;16(6):338-52. doi: 10.1016/j.tics.2012.04.008. Epub 2012 May 19.
PubMed 22609315Dodich A, Cerami C, Crespi C, Canessa N, Lettieri G, Iannaccone S, Marcone A, Cappa SF, Cacioppo JT. Differential Impairment of Cognitive and Affective Mentalizing Abilities in Neurodegenerative Dementias: Evidence from Behavioral Variant of Frontotemporal Dementia, Alzheimer's Disease, and Mild Cognitive Impairment. J Alzheimers Dis. 2016;50(4):1011-22. doi: 10.3233/JAD-150605.
PubMed 26836153Padala PR, Padala KP, Lensing SY, Jackson AN, Hunter CR, Parkes CM, Dennis RA, Bopp MM, Caceda R, Mennemeier MS, Roberson PK, Sullivan DH. Repetitive transcranial magnetic stimulation for apathy in mild cognitive impairment: A double-blind, randomized, sham-controlled, cross-over pilot study. Psychiatry Res. 2018 Mar;261:312-318. doi: 10.1016/j.psychres.2017.12.063. Epub 2018 Jan 5.
PubMed 29331848Ferrari C, Vecchi T, Todorov A, Cattaneo Z. Interfering with activity in the dorsomedial prefrontal cortex via TMS affects social impressions updating. Cogn Affect Behav Neurosci. 2016 Aug;16(4):626-34. doi: 10.3758/s13415-016-0419-2.
PubMed 27012713Cotelli M, Manenti R, Cappa SF, Zanetti O, Miniussi C. Transcranial magnetic stimulation improves naming in Alzheimer disease patients at different stages of cognitive decline. Eur J Neurol. 2008 Dec;15(12):1286-92. doi: 10.1111/j.1468-1331.2008.02202.x.
PubMed 19049544Cotelli M, Calabria M, Zanetti O. Cognitive rehabilitation in Alzheimer's Disease. Aging Clin Exp Res. 2006 Apr;18(2):141-3. doi: 10.1007/BF03327429.
PubMed 16702783Riccitelli GC, Beeching F, Lecchi A, Ongaro G, Pertoldi W, Kaelin-Lang A, Sacco L. Enhancing Social Cognition in Mild Cognitive Impairment with Non-Invasive Brain Stimulation: A Randomized Clinical Trial. Neurorehabil Neural Repair. 2025 Dec;39(12):972-982. doi: 10.1177/15459683251360731. Epub 2025 Aug 21.
PubMed 40838395
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECTS OF rTMS TREATMENT ON SOCIAL COGNITION DYSFUNCTIONS IN MILD COGNITIVE IMPAIRMENT: AN PROSPECTIVE, DOUBLE-BINDING, RANDOMIZED, SINGLE CENTRE, EXPLORATIVE STUDY
- ClinicalTrials.gov ID
- NCT04490616
- Acronym / sponsor ID
- 2020-00434/CE 3594
- Conditions
- Mild Cognitive Impairment
- Keywords
- ripetitive transcranial magnetic stimulation treatment, social cognition, theory of mind, empathy, social perception, social behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Ospedale Regionale di LuganoUniversity, hospital or other
- Study start
- 11 Feb 2021 (actual)
- Primary completion
- 28 Feb 2024 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 29 Jul 2020 (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.
Social cognitive abilities are impaired in around 17% of subjects with mild cognitive impairment (MCI), and might not reflect upon functional status. Compared to healthy controls, MCI showed impairments in theory of mind (ToM) and facial emotion recognition. Moreover, in amnesic MCI patients, reduced ToM ability appears to be correlated with worse performances at several cognitive performances. These findings, in agreement with previous evidence, confirm that impaired social cognition might occur prior to dementia: typically elderly start to show impairment in the complex ToM levels, which is found also in MCI patients and proceeds further in AD patients. Thus, the treatment of these aspects has the potential to influence the trajectory of neurodegeneration. In the last decade, it has been increasingly evident the effectiveness of active stimulation of brain regions with repetitive transcranial magnetic stimulation (rTMS), to improve cognitive and functional performances in patients with dementia.
On the other hand, brain imaging techniques and TMS stimulations have identified two main areas responsible for human social cognition- the medial prefrontal cortex (MPFC) and the right temporo-parietal junction (RTPJ).
In this project, we hypothesized that an improvement of social cognition skills may be obtained in MCI patients by using the rTMS on two main areas responsible for human social cognition- the medial prefrontal cortex (MPFC) and the right temporoparietal junction (RTPJ). Moreover, it expects that rTMS treatment may also contribute to improving cognitive abilities and neuropsychiatric aspects partially modulated by the same networks stimulated.
Detailed description
This is a prospective, double-binding, cross-sectional, randomized, sham-controlled, and single-center project aimed to investigate the effect of rTMS treatment of social cognition abilities in MCI subjects at 2 and 4 weeks, and after 8 weeks from baseline.
All patients will be recruited at Clinical Neuroscience Institute, Department of Neurology, Regional Civic Hospital, Lugan; Department of Geriatric Italian Hospital Viganello; and Department of Geriatric, Beata Vergine Hospital Mendrisio; Southern Switzerland, Switzerland.
Primary objective:
- To investigate whether the application of high-frequency rTMS, for 2 or 4 weeks, to the RPTJ and MPFC resulted in social cognitive improvements.
Secondary objectives:
- To verify whether the social cognition benefits previously recorded might persist after 8 weeks the end of the stimulation, with a major benefit with a longer rTMS application (4 weeks).
- To investigate whether the application of high-frequency rTMS, at 2 weeks or 4 weeks, to the RPTJ and MPFC contributes to improve cognitive functions as well as neuropsychiatric (depression) and functional aspects.
- To verify whether the cognitive functions, neuropsychiatric aspect, and functional benefits previously recorded persist after the end of the rTMS stimulation.
Primary analysis: To investigate the behavioral effects induced by the rTMS protocol after 2 and 4 weeks of daily stimulation on social cognition skills, executive/attentive functions, neuropsychiatric and functional aspects will be used a mixed-model ANOVA, considering the group as a between-subjects factor, and time as a within-subject factor.
Secondary Analyses: To investigate the direct or mediated rTMS effect on social cognition skills, a multivariate linear regression analysis will be done for each social cognition measure (ToM, empathy, social perception, social behavior) changes after rTMS treatment at 2 and 4 weeks as the dependent factor, separately, and appropriate screening/baseline dependent variables and rTMS groups as independent factors.
The evaluation and treatment of social cognition alterations in subjects with MCI can be useful for two main aspects: first, the mild cognitive and behavior impairment of these subjects favor a better answer at the treatment, both at the behavioral level and in terms of brain structural and functional response; second, treatment of these abilities in MCI population might retard the conversion to dementia. More importantly, the detection of predominant social cognition alteration in early phases of cognitive decline might be potentially helpful to differentiate individuals who will develop frontotemporal dementia. Therefore, it is important to investigate and define a treatment protocol to limit social cognition disturbances in MCI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- In the project will be applied a two-site repetitive transcranial magnetic stimulation (rTMS) stimulation. MCI patients that obtained a score ≤ 10 percentiles, at least one performance/domain of social cognition assessment will be considered impaired at social cognition abilities. In the same day of cognitive-behavioral assessment, patients will be randomly assigned to one of the two groups: 1) RR-Gr received 4 weeks of rTMS stimulation of the RTPJ and MPFC; (2) SR-Gr received of the RTPJ and MPFC sham stimulation during the first 2 weeks followed by 2 weeks of real stimulation. Each week of rTMS treatment consisted of five sessions. This paradigm has proven to be effective for improve cognitive performances in AD patients. In the sham condition, a sham coil will be used.
| Arm | Type | Receives |
|---|---|---|
| RR-GR | Experimental | Other: rTMS treatmentMCI patients with social cognition deficits will receive 4 weeks of rTMS stimulation |
| SR-GR | Other | Other: rTMS treatmentMCI patients with social cognition deficits will receive 2 weeks of placebo treatment, followed by 2 weeks of real rTMS stimulation |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subjects aged 50 to 85 years old, inclusive, at the time of informed consent;
- Must have at least 5 years of education or work experience to exclude mental deficits other than MCI;
- Must meet Petersen's criteria for mild cognitive impairment, and must have:
- Clinical dementia rating global score of 0.5;
- Mini-Mental State Examination score between 24 and 30;
Key exclusion criteria (8 listed)
- Any uncontrolled medical or neurological/neurodegenerative condition (other than MCI);
- Clinical significant unstable psychiatric illness requiring treatment with neuroleptic;
- Transient ischemic attack, stroke, or any unexplained loss of consciousness or severe ongoing stressor within 1 year prior to screening;
- History of seizure within10 years prior to screening;
- Recent history of alcohol or substance abuse or use of cannabinoids;
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 |
|---|---|---|
| rTMS treatmentA two-site rTMS stimulation delivered by a Magstim unit featuring a double 70 mm cooled coil will be applied. MCI patients will be randomly assigned to one of the two study groups: 1. RR-Gr will receive 4 weeks of rTMS stimulation of the right temporo-parietal junction (RTPJ) and medial prefrontal cortex (MPFC); 2. PL-Gr will receive sham stimulation of the RTPJ and MPFC during the first 2 weeks followed by 2 weeks of real stimulation. Each week of rTMS treatment will consist of five sessions (50 min, one per day). For each area target, a total of 2000 pulses at 20Hz, 3-s train duration, and 28-s inter-train interval at 100% motor threshold (MT) will be delivered per session. A fixed intensity of MT will ensure a more consistent spatial spread of TMS effects in subjects' brains not influenced by differences in individual MT. In the sham condition, a sham coil will be used. Each session lasted for about 60 min including time for set up and 50 min of stimulation. | Other | RR-GR, SR-GR |
Primary outcome
Comparison of Deceptive Box Task score
Time frame: Week 2
(5 items). Minimum value=0, maximum value=5. A higher score means a better outcome.
Comparison of Look-prediction/say-prediction test score
Time frame: Week 2
(5 items). Minimum value=0, maximum value=5. A higher score means a better outcome.
Comparison of Empathy Quotient score
Time frame: Week 2
(60 items). Minimum value=0, maximum value=80. A higher score means a better outcome.
Comparison of Ekman 60 test score
Time frame: Week 2
(60 b/w pictures). Minimum value=0, maximum value=60. Higher score means a better outcome.
Comparison of Frontal Behavioral Inventory score
Time frame: Week 2
(24 items). Minimum value=0, maximum value=69. Higher score means a worse outcome.
Comparison of Deceptive Box Task score
Time frame: Week 4
(5 items). Minimum value=0, maximum value=5. A higher score means a better outcome.
Comparison of Look-prediction/say-prediction test
Time frame: Week 4
(5 items). Minimum value=0, maximum value=5. A higher score means a better outcome.
Comparison of Empathy Quotient score
Time frame: Week 4
(60 items). Minimum value=0, maximum value=80. A higher score means a better outcome.
Comparison of Ekman 60 test score
Time frame: Week 4
(60 b/w pictures). Minimum value=0, maximum value=60. Higher score means a better outcome.
Comparison of Frontal Behavioral Inventory score
Time frame: Week 4
(24 items). Minimum value=0, maximum value=69. Higher score means a worse outcome.
8 secondary outcomes
Changes from baseline in Deceptive Box Task Test.
Time frame: Week 12
Changes from baseline in Look/say Test
Time frame: Week 12
Changes from baseline in Empathy Quotient scale
Time frame: Week 12
Changes from baseline in Ekman 60 Test
Time frame: Week 12
Changes from baseline in Frontal Behavioral Inventory
Time frame: Week 12
Comparison Montreal Cognitive Assessment
Time frame: through study completion, an average of 12 weeks
Comparison of Geriatric Depression Scale score
Time frame: through study completion, an average of 12 weeks
Comparison of Euroquol-5 dimensions score
Time frame: athrough study completion, an average of 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2025.
- Background: PubMed 22407224Freedman M, Binns MA, Black SE, Murphy C, Stuss DT. Theory of mind and recognition of facial emotion in dementia: challenge to current concepts. Alzheimer Dis Assoc Disord. 2013 Jan-Mar;27(1):56-61. doi: 10.1097/WAD.0b013e31824ea5db.
- Results publication: PubMed 18771388Adolphs R. The social brain: neural basis of social knowledge. Annu Rev Psychol. 2009;60:693-716. doi: 10.1146/annurev.psych.60.110707.163514.
- Results publication: PubMed 25961468Wondra JD, Ellsworth PC. An appraisal theory of empathy and other vicarious emotional experiences. Psychol Rev. 2015 Jul;122(3):411-28. doi: 10.1037/a0039252. Epub 2015 May 11.
- Results publication: PubMed 15701227Apperly IA, Samson D, Chiavarino C, Humphreys GW. Frontal and temporo-parietal lobe contributions to theory of mind: neuropsychological evidence from a false-belief task with reduced language and executive demands. J Cogn Neurosci. 2004 Dec;16(10):1773-84. doi: 10.1162/0898929042947928.
- Results publication: PubMed 15563720Wood JN, Knutson KM, Grafman J. Psychological structure and neural correlates of event knowledge. Cereb Cortex. 2005 Aug;15(8):1155-61. doi: 10.1093/cercor/bhh215. Epub 2004 Nov 24.
- Results publication: PubMed 18381770Van Overwalle F. Social cognition and the brain: a meta-analysis. Hum Brain Mapp. 2009 Mar;30(3):829-58. doi: 10.1002/hbm.20547.
- Results publication: PubMed 16552413Amodio DM, Frith CD. Meeting of minds: the medial frontal cortex and social cognition. Nat Rev Neurosci. 2006 Apr;7(4):268-77. doi: 10.1038/nrn1884.
- Results publication: PubMed 22609315Cabeza R, Ciaramelli E, Moscovitch M. Cognitive contributions of the ventral parietal cortex: an integrative theoretical account. Trends Cogn Sci. 2012 Jun;16(6):338-52. doi: 10.1016/j.tics.2012.04.008. Epub 2012 May 19.
- Results publication: PubMed 26836153Dodich A, Cerami C, Crespi C, Canessa N, Lettieri G, Iannaccone S, Marcone A, Cappa SF, Cacioppo JT. Differential Impairment of Cognitive and Affective Mentalizing Abilities in Neurodegenerative Dementias: Evidence from Behavioral Variant of Frontotemporal Dementia, Alzheimer's Disease, and Mild Cognitive Impairment. J Alzheimers Dis. 2016;50(4):1011-22. doi: 10.3233/JAD-150605.
- Results publication: PubMed 29331848Padala PR, Padala KP, Lensing SY, Jackson AN, Hunter CR, Parkes CM, Dennis RA, Bopp MM, Caceda R, Mennemeier MS, Roberson PK, Sullivan DH. Repetitive transcranial magnetic stimulation for apathy in mild cognitive impairment: A double-blind, randomized, sham-controlled, cross-over pilot study. Psychiatry Res. 2018 Mar;261:312-318. doi: 10.1016/j.psychres.2017.12.063. Epub 2018 Jan 5.
- Results publication: PubMed 27012713Ferrari C, Vecchi T, Todorov A, Cattaneo Z. Interfering with activity in the dorsomedial prefrontal cortex via TMS affects social impressions updating. Cogn Affect Behav Neurosci. 2016 Aug;16(4):626-34. doi: 10.3758/s13415-016-0419-2.
- Results publication: PubMed 19049544Cotelli M, Manenti R, Cappa SF, Zanetti O, Miniussi C. Transcranial magnetic stimulation improves naming in Alzheimer disease patients at different stages of cognitive decline. Eur J Neurol. 2008 Dec;15(12):1286-92. doi: 10.1111/j.1468-1331.2008.02202.x.
- 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.
Leonardo Sacco, Dr principal investigator
+41 091 811 6921
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rTMS treatment in people with Mild Cognitive Impairment, run by Ospedale Regionale di Lugano at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. 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: finished, as of the sponsor's last update on 20 Mar 2025. 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 Switzerland. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of Deceptive Box Task score (time frame: Week 2). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04490616, which also lists 14 linked publications.
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 20 Mar 2025.