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

Healthy Cognition Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05542641
• Other study ID #: NL82268.029.22
• Status: Recruiting
• Phase: N/A
• Start date: April 25, 2023
• Est. completion date: November 2024

Study information

• Verified date: April 2023
• Source: Amsterdam UMC, location VUmc
• Contact: Lucas C Breedt, MSc
• Phone: +31 6 1546 71 56
• Email: tmult[@]amsterdamumc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: November 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Cognition

Intervention

Device:
• repetitive transcranial magnetic stimulation (rTMS)
real versus sham rTMS

Locations

Country	Name	City	State
Netherlands	VU University Medical Centers, location VUmc	Amsterdam

Sponsors (1)

Lead Sponsor	Collaborator
Amsterdam UMC, location VUmc

Country where clinical trial is conducted

Netherlands, 

Outcome

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