Trial Outcomes & Findings for A Pilot fMRI Study of TMS in Late-Life Severe Worry (NCT NCT03577106)
NCT ID: NCT03577106
Last Updated: 2023-06-22
Results Overview
Penn State Worry Questionnaire (PSWQ) scores range from 16 to 80 with higher levels indicating greater worry severity.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
24 participants
Primary outcome timeframe
Baseline and within 2 weeks post-TMS intervention
Results posted on
2023-06-22
Participant Flow
A total of 63 participants from the parent study, FINA, were phone screened for this study. 28 of those individuals signed consent for this study, but 4 of the 28 were deemed ineligible for the study prior to the TMS intervention, leaving a total of 24 participants being enrolled in the study that received at least 1 session of TMS treatment.
After signing consent, but prior to starting the TMS intervention, participants were asked to complete a Penn State Worry Questionnaire to assess anxiety/worry levels. Individuals with a PSWQ score of 55 or higher qualified for the study intervention, and those with a score of 54 or lower were excluded from the study. Participants with low PSWQ scores were excluded as treatment was relevant only for high worriers.
Participant milestones
| Measure |
Transcranial Magnetic Stimulation (TMS)
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.
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|---|---|
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Overall Study
STARTED
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24
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Overall Study
COMPLETED
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21
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Overall Study
NOT COMPLETED
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3
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Reasons for withdrawal
| Measure |
Transcranial Magnetic Stimulation (TMS)
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.
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|---|---|
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Overall Study
Withdrawal by Subject
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3
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Baseline Characteristics
PSWQ analysis includes only the 21 participants who completed the full trial of TMS treatment. The 3 participants who withdrew from the study were not included within this data as they do not have follow-up PSWQ scores to analyze.
Baseline characteristics by cohort
| Measure |
Transcranial Magnetic Stimulation (TMS)
n=24 Participants
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.
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=24 Participants
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Age, Categorical
Between 18 and 65 years
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22 Participants
n=24 Participants
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Age, Categorical
>=65 years
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2 Participants
n=24 Participants
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Sex: Female, Male
Female
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17 Participants
n=24 Participants
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Sex: Female, Male
Male
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7 Participants
n=24 Participants
|
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Ethnicity (NIH/OMB)
Hispanic or Latino
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1 Participants
n=24 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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23 Participants
n=24 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=24 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=24 Participants
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Race (NIH/OMB)
Asian
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0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=24 Participants
|
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Race (NIH/OMB)
Black or African American
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4 Participants
n=24 Participants
|
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Race (NIH/OMB)
White
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19 Participants
n=24 Participants
|
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Race (NIH/OMB)
More than one race
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1 Participants
n=24 Participants
|
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=24 Participants
|
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Region of Enrollment
United States
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24 participants
n=24 Participants
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Penn State Worry Questionnaire (PSWQ) Score
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68.62 units on a scale
n=21 Participants • PSWQ analysis includes only the 21 participants who completed the full trial of TMS treatment. The 3 participants who withdrew from the study were not included within this data as they do not have follow-up PSWQ scores to analyze.
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PRIMARY outcome
Timeframe: Baseline and within 2 weeks post-TMS interventionPopulation: Participants who completed study TMS protocol
Penn State Worry Questionnaire (PSWQ) scores range from 16 to 80 with higher levels indicating greater worry severity.
Outcome measures
| Measure |
Transcranial Magnetic Stimulation (TMS)
n=21 Participants
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.
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|---|---|
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Change in Worry Severity From Baseline to Post-intervention as Measured by the Penn State Worry Questionnaire (PSWQ)
PSWQ Score after TMS Treatment
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62.43 units on a scale (PSWQ)
Standard Deviation 10.28
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Change in Worry Severity From Baseline to Post-intervention as Measured by the Penn State Worry Questionnaire (PSWQ)
Change from Baseline at Two Weeks
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6.19 units on a scale (PSWQ)
Standard Deviation 8.5
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PRIMARY outcome
Timeframe: Baseline and the end of TMS intervention (approximately two weeks)Population: The breakdown of participants who responded to TMS treatment; responders had Penn State Worry Questionnaire (PSWQ) scores that decreased by 30% or more from the baseline timepoint to the end of TMS treatment.
The breakdown of participants who responded to TMS treatment; responders had Penn State Worry Questionnaire (PSWQ) scores that decreased by 30% or more from the baseline timepoint to the end of TMS treatment.
Outcome measures
| Measure |
Transcranial Magnetic Stimulation (TMS)
n=21 Participants
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.
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|---|---|
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Participants Who Responded to TMS
TMS Responders
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2 Participants
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Participants Who Responded to TMS
TMS Non-responders
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19 Participants
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Adverse Events
Transcranial Magnetic Stimulation (TMS)
Serious events: 1 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Transcranial Magnetic Stimulation (TMS)
n=24 participants at risk
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.
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|---|---|
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Renal and urinary disorders
Kidney Stone
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4.2%
1/24 • Number of events 1 • Adverse events were systematically assessed daily for the 2 weeks of TMS treatment for each participant, and non-systematically assessed as needed throughout the entire study, an average of 6 weeks.
Participants were monitored throughout the TMS protocol, and asked twice a session to describe any discomfort they experienced, along with rating this discomfort on a scale. Participants were also able to report discomfort at any time during treatment, to which the study team would respond accordingly.
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Other adverse events
| Measure |
Transcranial Magnetic Stimulation (TMS)
n=24 participants at risk
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.
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|---|---|
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Musculoskeletal and connective tissue disorders
Jaw clenching/Teeth Rattling
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83.3%
20/24 • Adverse events were systematically assessed daily for the 2 weeks of TMS treatment for each participant, and non-systematically assessed as needed throughout the entire study, an average of 6 weeks.
Participants were monitored throughout the TMS protocol, and asked twice a session to describe any discomfort they experienced, along with rating this discomfort on a scale. Participants were also able to report discomfort at any time during treatment, to which the study team would respond accordingly.
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Skin and subcutaneous tissue disorders
Tapping Sensation on Scalp/Eye or Cheek Twitch
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87.5%
21/24 • Adverse events were systematically assessed daily for the 2 weeks of TMS treatment for each participant, and non-systematically assessed as needed throughout the entire study, an average of 6 weeks.
Participants were monitored throughout the TMS protocol, and asked twice a session to describe any discomfort they experienced, along with rating this discomfort on a scale. Participants were also able to report discomfort at any time during treatment, to which the study team would respond accordingly.
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Musculoskeletal and connective tissue disorders
Neck Muscle Twitching
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8.3%
2/24 • Adverse events were systematically assessed daily for the 2 weeks of TMS treatment for each participant, and non-systematically assessed as needed throughout the entire study, an average of 6 weeks.
Participants were monitored throughout the TMS protocol, and asked twice a session to describe any discomfort they experienced, along with rating this discomfort on a scale. Participants were also able to report discomfort at any time during treatment, to which the study team would respond accordingly.
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Musculoskeletal and connective tissue disorders
Headache
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37.5%
9/24 • Adverse events were systematically assessed daily for the 2 weeks of TMS treatment for each participant, and non-systematically assessed as needed throughout the entire study, an average of 6 weeks.
Participants were monitored throughout the TMS protocol, and asked twice a session to describe any discomfort they experienced, along with rating this discomfort on a scale. Participants were also able to report discomfort at any time during treatment, to which the study team would respond accordingly.
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General disorders
Unsteadiness/Dizziness
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12.5%
3/24 • Adverse events were systematically assessed daily for the 2 weeks of TMS treatment for each participant, and non-systematically assessed as needed throughout the entire study, an average of 6 weeks.
Participants were monitored throughout the TMS protocol, and asked twice a session to describe any discomfort they experienced, along with rating this discomfort on a scale. Participants were also able to report discomfort at any time during treatment, to which the study team would respond accordingly.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place