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A Pilot fMRI Study of TMS in Late-Life Severe Worry (TINA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03577106
Recruitment Status : Suspended (Due to the Covid-19 pandemic)
First Posted : July 5, 2018
Last Update Posted : May 4, 2020
Sponsor:
Information provided by (Responsible Party):
Carmen Andreescu, University of Pittsburgh

Brief Summary:

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 [4], Further, changes in sleep in response to TMS has been associated with how participants respond to the TMS as a treatment [5]. 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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants must have completed Dr. Andreescu's study R01MH108509/PRO15080120.
  • Penn State Worry Questionnaire score of 55 or above.

Exclusion Criteria:

  • Any form of psychosis or Bipolar Disorder, dementia, a history of substance abuse within the last six months
  • Use of antidepressants within the last five to fourteen days (adequate washout interval to be determined by the principal investigator (PI) based on each specific antidepressant). For fluoxetine, the washout interval will be six weeks. However, for participants who are prescribed low dose psychotropics for pain, sleep disturbances, and/or medical conditions (e.g. amitriptyline for peripheral neuropathy, low dose trazodone as a sleep aid), these will be allowed in most circumstances. We will include participants on certain dosages of the most commonly prescribed antidepressants (for medical reasons) as follows: amitriptyline up to 50 mg/d, doxepin up to 50 mg/d, trazodone up to 100 mg/d, and imipramine up to 50 mg/d. We will review other cases individually and the PI will decide if the participants are eligible for the study and if they may continue the current medication.
  • Unable to complete MRI scans: presence of ferromagnetic metal in the body, claustrophobia
  • Contraindications for TMS:

    1. Presence of a neurologic disorder or medical condition known to alter seizure threshold(e.g., stroke, aneurysm, brain surgery, structural brain lesion, brain injury, frequent/severe headaches)
    2. Recurrent seizures or epilepsy in participant
    3. Pregnancy
    4. Metallic implants in body located at 30 cm or less from the position of the magnetic coil; presence in the body of other devices that may be affected by magnetic field (e.g. pacemakers).
  • Unable to temporarily discontinue benzodiazepines 48 hours prior to MRI scan. Participants on high doses of benzodiazepines (e.g., greater than or equivalent to 2 mg of lorazepam) will be excluded, given the complexity and potential complications of benzodiazepine taper/withdrawal.

Information from the National Library of Medicine

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


Locations
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United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
Carmen Andreescu
Investigators
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Principal Investigator: Carmen Andreescu, MD University of Pittsburgh
  Study Documents (Full-Text)

Documents provided by Carmen Andreescu, University of Pittsburgh:
Additional Information:
Publications:
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Responsible Party: Carmen Andreescu, Associate Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT03577106    
Other Study ID Numbers: STUDY19020109
First Posted: July 5, 2018    Key Record Dates
Last Update Posted: May 4, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Carmen Andreescu, University of Pittsburgh:
transcranial magnetic stimulation
TMS
MRI
magnetic resonance imaging
fMRI
functional magnetic resonance imaging
sleep
intermittent theta burst stimulation
iTBS
Additional relevant MeSH terms:
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Anxiety Disorders
Mental Disorders