Effect of cTBS on Startle and TMS-evoked BOLD

ConditionAnxiety

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-50

SponsorUniversity of Pennsylvania

About this trial

The right dorsolateral prefrontal cortex (dlPFC) is increasingly being targeted with transcranial magnetic stimulation (TMS) to reduce anxiety expression; however, there is little mechanistic evidence supporting an optimized treatment protocol. Thus, the objective of the current project is to develop an interleaved TMS/fMRI that can assess the effect of neuromodulatory (potentially therapeutic) TMS protocols on neural and behavioral measures related to anxiety expression. PUBLIC HEALTH RELEVANCE: These results will yield direct evidence that 1 Hz and cTBS modulate brain activity associated with anxiety expression and regulation, thus informing novel TMS based anxiety treatments.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Able to give their consent

Right-handed

Individuals receiving therapy for anxiety must be stable on their regimen for at least 4 weeks prior to study enrollment.

Disqualifiers

Non-english speaking

Any significant medical or neurological problems

Current or past non-anxiety-related psychiatric comorbidity, active or history of active suicidal ideation

Alcohol/drug problems in the past year or lifetime alcohol or drug dependence

Trial design

Design model

Crossover

Treatments tested in this trial

Active TMS
Device
Subjects will receive a continuous 1800 pulse cTBS train to the right dlPFC at 100% of motor threshold. The train will consist of 50 Hz bursts, repeated at intervals of 200 ms (5 Hz) for 40 sec.
Sham TMS
Device
Subjects will receive a series of 100 single pulses to the right dlPFC at 100% of motor threshold. Pulses will be randomly jittered and have an average interpulse interval of 6 ± 4 seconds. Single pulses delivered in such a fashion have been shown to have little or no neuromodulatory effect on subsequent cortical excitability.

Treatment groups

140 Participants

are divided into 1 treatment group

Group A: Transcranial Magnetic StimulationOther 2 interventions

Trial outcomes

Primary outcomes

TMS-evoked BOLD responses

Subjects will complete 16 minutes of high-resolution multi-band, multi-echo interleaved TMS/fMRI before and after the TMS. During these runs, subjects will receive periodic single pulses of TMS delivered to the right dlPFC. TMS-evoked BOLD responses to these pulses will be the primary outcome measure

Time frame

Subjects will undergo 4 study visits spaced over a 5-week period. On visits 3 (week 2) and 4 (week 5), TMS-evoked BOLD responses will be recorded immediately (within 5 minutes) before and after the intervention.

Anxiety Potentiated Startle

Subjects will complete the NPU threat task. The primary outcome, APS, will be calculated by subtracting the blink magnitude during the neutral ITI from the unpredictable ITI. We hypothesize that cTBS will reduce APS compared to sham TMS.

Time frame

Subjects will undergo 4 study visits spaced over a 5-week period. On visits 3 (week 2) and 4 (week 5), Anxiety Potentiated Startle will be recorded immediately (within 15 minutes) before and after the intervention.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Pennsylvania

Lead sponsor

Source ClinicalTrials.gov

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