An interventional study of repetitive transcranial magnetic stimulation and Sham repetitive transcranial magnetic stimulation in Amygdala Activation, sponsored by Duke University. Completed at 1 site in United States. Open to participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-12-10.
Sponsored by Duke University · Not applicable, Interventional, and Basic science
Posttraumatic stress disorder (PTSD) is a highly debilitating disease with response rates to pharmacological treatment rarely exceeding 60%. Preliminary attempts have been made to use repetitive transcranial magnetic stimulation (rTMS) as a non-pharmacological treatment alternative, but thus far rTMS approaches have demonstrated only modest efficacy. A major factor contributing to these limited effects stems from the depth penetration of TMS, which is not sufficient to directly modulate deep subcortical structures, such as the amygdala, that are affected in PTSD. Moreover, while rTMS effects have been shown to be state-dependent, (i.e. vary substantially according to the neural state during stimulation), this important factor is rarely considered during the clinical application of rTMS. The current study addresses both of these limitations to improve the therapeutic efficacy of rTMS for PTSD. Here we will develop a protocol to test if connectivity-based rTMS is able to modulate amygdala activity through the functional connections with medial prefrontal cortex, taking advantage of state-dependency to enhance rTMS effects by actively engaging the amygdala through a fear perception task. BOLD activation in the amygdala and its connectivity with the frontal cortex will constitute the primary outcomes to test rTMS efficacy. Heart rate variability and skin galvanic responses, acquired during the presentation of fearful faces, will be used as continuous moderators of task engagement during rTMS. If successful, this study will pave the way for a large-scale study to investigate whether state-dependent, connectivity-based rTMS of the amygdala can improve rTMS efficacy as a clinical treatment for PTSD.
Duke University is the lead sponsor of 2,025 studies on the registry; 275 are open to participants now.
Of its 194 completed or terminated interventional studies of FDA-regulated products, 159 (82%) have results posted.
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Exclusion Criteria:
excitatory rTMS applied over the medial prefrontal cortex (fMRI-guided)
Device: repetitive transcranial magnetic stimulation
electrical sham coil applied over the medial prefrontal cortex (fMRI-guided)
Device: Sham repetitive transcranial magnetic stimulation
excitatory 5Hz rTMS will be used
an electrical sham coil reproducing the same clicking sound and tactile sensation than the active rTMS will be used
Acute Effect of a rTMS Session on Brain Activation as Measured by the Cerebral Blood Flow (Blood Oxygenation Level Dependent Signal)
Blood oxygenation level dependent (BOLD) will be assessed to evaluate the acute effect of rTMS applied over the medial prefrontal cortex on the amygdala activation. This outcome (expressed a z-score) represents the amygdala activation, either after active rTMS or after sham rTMS. Higher z-scores for active than for sham rTMS indicates that amygdala activity increases after active rTMS compared to sham rTMS, on the other hand lower z-score after active rTMS vs. after Sham rTMS indicated that the amygdala activity would have been reduced with active rTMS.
Time frame: right after the rTMS session, up to one hour
| Milestone | Repetitive TMS (rTMS) | Sham Repetitive TMS (rTMS) |
|---|---|---|
| Started | 10 | 8 |
| Completed | 7 | 6 |
| Not completed | 3 | 2 |
| Withdrew: Withdrawal by subject | 3 | 0 |
| Withdrew: Technical difficulties | 0 | 2 |
Blood oxygenation level dependent (BOLD) will be assessed to evaluate the acute effect of rTMS applied over the medial prefrontal cortex on the amygdala activation. This outcome (expressed a z-score) represents the amygdala activation, either after active rTMS or after sham rTMS. Higher z-scores for active than for sham rTMS indicates that amygdala activity increases after active rTMS compared to sham rTMS, on the other hand lower z-score after active rTMS vs. after Sham rTMS indicated that the amygdala activity would have been reduced with active rTMS.
| z score in the amygdala | Repetitive TMS (rTMS) | Sham Repetitive TMS (rTMS) |
|---|---|---|
| Acute Effect of a rTMS Session on Brain Activation as Measured by the Cerebral Blood Flow (Blood Oxygenation Level Dependent Signal) | 0.67 ± 0.48 | -0.48 ± 0.87 |
Collected over during rTMS application, and up to one hour after.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Repetitive TMS (rTMS) | 0/7 (0%) | 0/7 (0%) | 0/7 (0%) |
| Sham Repetitive TMS (rTMS) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) |
Participants who were randomized in the active or sham group.
| Age, Categorical(Participants) | Repetitive TMS (rTMS) | Sham Repetitive TMS (rTMS) | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 10 | 8 | 18 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Repetitive TMS (rTMS) | Sham Repetitive TMS (rTMS) | Total |
|---|---|---|---|
| Female | 7 | 4 | 11 |
| Male | 3 | 4 | 7 |
| Race/Ethnicity, Customized(Participants) | Repetitive TMS (rTMS) | Sham Repetitive TMS (rTMS) | Total |
|---|---|---|---|
| Ethnicity — African American | 1 | 0 | 1 |
| Ethnicity — Asian | 5 | 3 | 8 |
| Ethnicity — White | 4 | 5 | 9 |
| Region of Enrollment(Participants) | Repetitive TMS (rTMS) | Sham Repetitive TMS (rTMS) | Total |
|---|---|---|---|
| United States | 10 | 8 | 18 |
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