NCT05542641

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 7, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 15, 2022

Completed
7 months until next milestone

Study Start

First participant enrolled

April 25, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 3, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 26, 2025

Completed
Last Updated

May 31, 2025

Status Verified

May 1, 2025

Enrollment Period

1.8 years

First QC Date

September 7, 2022

Last Update Submit

May 26, 2025

Conditions

Healthy Cognition

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Brain network change

    baseline versus directly post-intervention (max. 8 weeks after baseline)

Study Arms (2)

real rTMS

EXPERIMENTAL

verum rTMS to the DLPFC, 1500 1Hz pulses at 120% RMT, 25 minutes total

Device: repetitive transcranial magnetic stimulation (rTMS)

sham rTMS

SHAM COMPARATOR

sham rTMS to the DLPFC, 1500 1Hz pulses at 120% RMT, 25 minutes total

Device: repetitive transcranial magnetic stimulation (rTMS)

Interventions

repetitive transcranial magnetic stimulation (rTMS)DEVICE

real versus sham rTMS

real rTMSsham rTMS

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VU University Medical Centers, location VUmc

Amsterdam, 1081 HV, Netherlands

Location

MeSH Terms

Interventions

Transcranial Magnetic Stimulation

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Study Officials

  • Linda Douw, PhD

    Amsterdam UMC, location VUmc

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 7, 2022

First Posted

September 15, 2022

Study Start

April 25, 2023

Primary Completion

February 3, 2025

Study Completion

May 26, 2025

Last Updated

May 31, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will share

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).

Time Frame
Upon completion of the study
Access Criteria
See plan description

Locations

NL(1)