Comparison of Targeting Methods for Transcranial Magnetic Stimulation Treatment of Depression

Part of paid clinical trials in Stanford, California.

Sponsor
Stanford University
Study ID
NCT04730180
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Transcranial Magnetic Simulation — DEVICE
    Brain stimulation treatment will be performed using FDA-cleared TMS coils according to their intended use of treatment of medication resistant depression by targeting the dorsolateral prefrontal cortex.
  • Mixed reality neuronavigation — DEVICE
    Targeting of the dorsolateral prefrontal cortex will be performed with the help of a mixed reality neuronavigation system.

Study Details

We aim to learn whether use of a mixed reality device for transcranial magnetic stimulation (TMS) targeting can improve treatment outcomes compared to targeting through scalp measurements or a commercial neuronavigation system. Prior studies indicate that neuronavigation can lead to improved treatment outcomes compared to scalp measurements, but neuronavigation adaption has been lacking due to the increased burden of the neuronavigation setup on the TMS operator. We will assess whether use of a mixed reality device can decrease that burden and speed up the neuronavigation process and is feasible to be used in a clinical setting.

Key Dates

Start date
Jan 1, 2024
Status verified
May 2021
Primary completion
Jul 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: No neuronavigation
    For this group, the stimulation location for repetitive transcranial stimulation treatment is estimated by the clinician via scalp measurements.
  • Active Comparator: Mixed reality neuronavigation
    For this group, the stimulation location for repetitive transcranial stimulation treatment is estimated by the clinician via a mixed reality neuronavigation device.

Primary Outcome Measure

Number of participants with response to TMS [ Time Frame: 9 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Stanford UniversityStanfordCalifornia94305
Jennifer A McNab
650-724-1195

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