Healthy CognitionNCT05542641
T-mult: Exploring the Impact of TMS Induced Virtual Lesions on the Multimodal Brain Network and Cognition
A study testing repetitive transcranial magnetic stimulation (rTMS) in people with Healthy Cognition, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
Trial summary
T-mult is an experimental study using low-frequency (1Hz) single-sesson rTMS to the DLPFC (versus sham rTMS) to explore the effect of virtual lesions on the brain network and cognition in 100 healthy adults (20-65 years old). Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Cognition
- What is being tested?
- repetitive transcranial magnetic stimulation (rTMS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 1 siteNetherlands
- Study dates
- 25 Apr 2023to 26 May 2025
- 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 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age between 20 and 65 years old
- Native Dutch speaker
- Able to provide written informed consent
Who cannot join
- History of diagnosed neurological or psychiatric disease (including traumatic head injury)
- Current and regular use of centrally acting drugs (recreational or prescribed, including analgesics), including the use of alcohol ~8 hours prior to an appointment
- Presence of any contraindications for MRI, MEG, or TMS (including resting motor threshold >75% of maximum stimulator output or no useful motor-evoked potential elicitable)
- Previous rTMS treatment
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
VU University Medical Centers, location VUmc
Amsterdam, 1081 HV
About this study
T-mult is an experimental study using low-frequency (1Hz) single-sesson rTMS to the DLPFC (versus sham rTMS) to explore the effect of virtual lesions on the brain network and cognition in 100 healthy adults (20-65 years old).
- Conditions
- Healthy Cognition
- Being tested
- repetitive transcranial magnetic stimulation (rTMS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
repetitive transcranial magnetic stimulation (rTMS)Device
real versus sham rTMS
| Study group | Role | What they receive |
|---|---|---|
| real rTMS | Experimental | verum rTMS to the DLPFC, 1500 1Hz pulses at 120% RMT, 25 minutes total Receives: Device: repetitive transcranial magnetic stimulation (rTMS) |
| sham rTMS | Sham comparator | sham rTMS to the DLPFC, 1500 1Hz pulses at 120% RMT, 25 minutes total Receives: Device: repetitive transcranial magnetic stimulation (rTMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive change
Change in performance on a neuropsychological test measuring cognitive functioning in the domain of executive functioning
Measured: baseline versus directly post-intervention (max. 8 weeks after baseline)
Secondary outcomes (1)
Brain network change
Change in brain network organization as characterised by multimodal neuroimaging
Measured: baseline versus directly post-intervention (max. 8 weeks after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2022
- Study start25 Apr 2023
- Primary completion3 Feb 2025
- Study completion26 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy CognitionStudies of the same condition, open and under way.
- More trials run by Amsterdam UMC, location VUmcThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amsterdam UMC, location VUmc
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Linda Douw, Amsterdam UMC, location VUmc
- Investigators
- Linda Douw, PhD, Principal investigator, Amsterdam UMC, location VUmc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05542641
- Sponsor's protocol ID
- NL82268.029.22
- Status last verified
- May 2025
- First submitted
- 7 Sep 2022
- Last updated
- 31 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: In the pursuit of open science, we intend to make this dataset available to a larger part of the scientific community. Participants will be asked for their permission to do so in the Informed Consent form; if permission is given we will, upon completion of the study, upload coded data that has been scrubbed of all PHI (i.e. clear all PHI in the header information, deface MR images) to DANS (Data Archiving and Networked Services, www.dans.knaw.nl), a Dutch repository for research data. DANS allows for the use of a "restricted access" license for the reuse of data that ensures anyone who wishes to use the data acts in accordance with applicable local laws and regulations (e.g. AVG). Note that participants who are unwilling to provide permission to share their data will still be included in this study (their data will then not be uploaded to DANS).
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- T-mult: Exploring the Impact of TMS Induced Virtual Lesions on the Multimodal Brain Network and Cognition
- ClinicalTrials.gov ID
- NCT05542641
- Acronym / sponsor ID
- NL82268.029.22
- Conditions
- Healthy Cognition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Amsterdam UMC, location VUmcUniversity, hospital or other
- Study start
- 25 Apr 2023 (actual)
- Primary completion
- 3 Feb 2025 (actual)
- Study completion
- 26 May 2025 (actual)
- First posted
- 15 Sep 2022 (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.
T-mult is an experimental study using low-frequency (1Hz) single-sesson rTMS to the DLPFC (versus sham rTMS) to explore the effect of virtual lesions on the brain network and cognition in 100 healthy adults (20-65 years old).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| real rTMS | Experimental | Device: repetitive transcranial magnetic stimulation (rTMS)verum rTMS to the DLPFC, 1500 1Hz pulses at 120% RMT, 25 minutes total |
| sham rTMS | Sham comparator | Device: repetitive transcranial magnetic stimulation (rTMS)sham rTMS to the DLPFC, 1500 1Hz pulses at 120% RMT, 25 minutes total |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age between 20 and 65 years old
- Native Dutch speaker
- Able to provide written informed consent
Key exclusion criteria (4 listed)
- History of diagnosed neurological or psychiatric disease (including traumatic head injury)
- Current and regular use of centrally acting drugs (recreational or prescribed, including analgesics), including the use of alcohol ~8 hours prior to an appointment
- Presence of any contraindications for MRI, MEG, or TMS (including resting motor threshold >75% of maximum stimulator output or no useful motor-evoked potential elicitable)
- Previous rTMS treatment
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 |
|---|---|---|
| repetitive transcranial magnetic stimulation (rTMS)real versus sham rTMS | Device | real rTMS, sham rTMS |
Primary outcome
Cognitive change
Time frame: baseline versus directly post-intervention (max. 8 weeks after baseline)
Change in performance on a neuropsychological test measuring cognitive functioning in the domain of executive functioning
1 secondary outcome
Brain network change
Time frame: baseline versus directly post-intervention (max. 8 weeks after baseline)
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 31 May 2025.
- Individual participant dataSharing planned: Yes. In the pursuit of open science, we intend to make this dataset available to a larger part of the scientific community. Participants will be asked for their permission to do so in the Informed Consent form; if permission is given we will, upon completion of the study, upload coded data that has been scrubbed of all PHI (i.e. clear all PHI in the header information, deface MR images) to DANS (Data Archiving and Networked Services, www.dans.knaw.nl), a Dutch repository for research data. DANS allows for the use of a "restricted access" license for the reuse of data that ensures anyone who wishes to use the data acts in accordance with applicable local laws and regulations (e.g. AVG). Note that participants who are unwilling to provide permission to share their data will still be included in this study (their data will then not be uploaded to DANS).
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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.
Linda Douw, PhD principal investigator
Amsterdam UMC, location VUmc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing repetitive transcranial magnetic stimulation (rTMS) in people with Healthy Cognition, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
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 3 inclusion and 4 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 31 May 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 Netherlands. 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?
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?
Cognitive change (time frame: baseline versus directly post-intervention (max. 8 weeks after baseline)). 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 31 May 2025.