T-mult: Exploring the Impact of TMS Induced Virtual Lesions on the Multimodal Brain Network and Cognition

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 Overview

• Status: Completed
• Conditions: Healthy Cognition
• Intervention / Treatment: Device: repetitive transcranial magnetic stimulation (rTMS)

• Study Type: Interventional
• Enrollment (Actual): 102
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Amsterdam, Netherlands, 1081 HV
    • VU University Medical Centers, location VUmc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Age between 20 and 65 years old
• Native Dutch speaker
• Able to provide written informed consent

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: real rTMS; verum rTMS to the DLPFC, 1500 1Hz pulses at 120% RMT, 25 minutes total	Device: repetitive transcranial magnetic stimulation (rTMS); real versus sham rTMS
Sham Comparator: sham rTMS; sham rTMS to the DLPFC, 1500 1Hz pulses at 120% RMT, 25 minutes total	Device: repetitive transcranial magnetic stimulation (rTMS); real versus sham rTMS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cognitive change	Change in performance on a neuropsychological test measuring cognitive functioning in the domain of executive functioning	baseline versus directly post-intervention (max. 8 weeks after baseline)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Brain network change	Change in brain network organization as characterised by multimodal neuroimaging	baseline versus directly post-intervention (max. 8 weeks after baseline)

Collaborators and Investigators

• Sponsor: Amsterdam UMC, location VUmc
• Investigators: Principal Investigator: Linda Douw, PhD, Amsterdam UMC, location VUmc

Study record dates

Study Major Dates

• Study Start (Actual): April 25, 2023
• Primary Completion (Actual): February 3, 2025
• Study Completion (Actual): May 26, 2025

Study Registration Dates

• First Submitted: September 7, 2022
• First Submitted That Met QC Criteria: September 12, 2022
• First Posted (Actual): September 15, 2022

Study Record Updates

• Last Update Posted (Actual): May 31, 2025
• Last Update Submitted That Met QC Criteria: May 26, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: NL82268.029.22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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).

• IPD Sharing Time Frame: Upon completion of the study
• IPD Sharing Access Criteria: See plan description

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No