A Pilot fMRI Study of TMS in Late-Life Severe Worry (TINA)
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|ClinicalTrials.gov Identifier: NCT03577106|
Recruitment Status : Suspended (Due to the Covid-19 pandemic)
First Posted : July 5, 2018
Last Update Posted : May 4, 2020
Investigators will test a novel intervention through experimental therapeutic approach using fMRI-directed Intermittent Theta Burst Stimulation (iTBS), a high frequency TMS paradigm, for the treatment of severe, uncontrollable worry. While worry is a universal human experience, severe and excessive worry has been recently linked to increased risk of stroke and other cardiovascular diseases, increased risk of conversion to Alzheimer's disease as well as to higher risk of all-cause mortality in midlife and late-life. Severe, uncontrollable worry has been repeatedly associated with reduced quality of life and impaired functioning. Current treatment choices (antidepressant/anxiolytic medications and psychotherapeutic interventions) have been proven moderately efficacious in reducing anxiety/depression burden, but ineffective in reducing worry severity, a phenomenon that may contribute to the high relapse rates associated with mood and anxiety disorders. Our research indicated that worry severity is associated with hyperactivation in specific regions such as orbital frontal cortex, superior parietal gyrus, amygdala and parahippocampal gyrus. This pilot study will explore the efficacy of targeting one of these regions with iTBS. Based on investigators' previous results, the most accessible target is the right superior parietal gyrus (rSPG) - a region that remained significantly associated with severe worry after controlling for effects of comorbid depression or overall anxiety. As this region showed an increased in cerebrovascular flow in association with worry severity, investigators will use iTBS (5x/week for 2 weeks) to modulate cortical plasticity in this region and consequently, to reduce worry severity.
TMS during wakefulness has been shown to alter subsequent sleep , Further, changes in sleep in response to TMS has been associated with how participants respond to the TMS as a treatment . Thus, the study will measure sleep throughout the protocol to determine whether sleep changes as a function of TMS and whether sleep changes are associated with treatment response.
|Condition or disease||Intervention/treatment||Phase|
|Anxiety Disorders Generalized||Device: Transcranial magnetic stimulation (TMS)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot fMRI Study of TMS in Late-Life Severe Worry|
|Actual Study Start Date :||December 6, 2018|
|Estimated Primary Completion Date :||August 25, 2021|
|Estimated Study Completion Date :||August 25, 2021|
|Experimental: Transcranial magnetic stimulation (TMS)||
Device: Transcranial magnetic stimulation (TMS)
Theta Burst Stimulation (TBS), a form of TMS, will be targeted to the Inferior Parietal Cortex based on neural navigation software. TBS will be delivered for about 5-6 minutes, five days a week for two weeks, for a total of ten sessions.
- Change in worry severity from baseline to post-intervention as measured by the Penn State Worry Questionnaire (PSWQ) [ Time Frame: Baseline and within 2 weeks post-TMS intervention ]PSWQ scores range from 16 to 80 with higher levels indicating greater worry severity. Responders will have a decrease in PSWQ of at least 30%. Both the mean score (pre and post-intervention) as well as response status (total number of participants who responded) will be reported.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03577106
|United States, Pennsylvania|
|University of Pittsburgh|
|Pittsburgh, Pennsylvania, United States, 15213|
|Principal Investigator:||Carmen Andreescu, MD||University of Pittsburgh|