Adults 60 to 85, any sex, with Executive Dysfunction or Depression. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change in Montgomery-Asberg Depression Rating Scale (MADRS) Scores From Baseline to the End of the InterventionPrimary· 6 weeks
We will assess the efficacy of iTBS in improving mood by determining if older adults randomized to iTBS will show significant decreases in the Montgomery-Asberg Depression Rating Scale consistent with improvement of depressive symptoms. The total score for the scale will be reported. The total scores range is 0 - 60 with 0 = minimum score and 60 the maximum score. A low score is better as it denotes less depressive symptoms.
Group
Value
95% CI
Active iTBS Treatment
10.25
± 6.40
Sham Stimulation
13.33
± 3.70
Change in the NIH Toolbox Executive Domain Measure Flanker Inhibitory Control and Attention TestPrimary· 6 weeks
Improvement in executive function in participants will be assessed by determining if subjects randomized to iTBS show significant increases in their NIH Toolbox Flanker Inhibitory control and attention test from baseline to the end of 6 weeks, compared to those randomized to sham.
NIH Tool box Flanker inhibitory control and attention test is a validated instrument measuring attention and inhibitory control.
The age corrected standard score is used, for which the normative mean is 100 and the standard deviation is 15. This score compares the score of the test taker to those in the NIH tool bo
Group
Value
95% CI
Active iTBS Treatment
1.38
± 8.7
Sham Stimulation
0.78
± 7.42
Change in the NIH Tool Box Executive Measure Dimensional Change Card Sort TestPrimary· 6 weeks
Improvement in executive function in participants will be assessed by determining if subjects randomized to iTBS show significant increases in their NIH Toolbox Dimensional change card sort test from baseline to the end of 6 weeks, compared to those randomized to sham.
NIH Tool box Dimensional change card sort test is a validated instrument measuring cognitive flexibility.
The age corrected standard score is used, for which the normative mean is 100 and the standard deviation is 15. This score compares the score of the test taker to those in the NIH tool box nationally representative sample
Group
Value
95% CI
Active iTBS Treatment
1.00
± 10.98
Sham Stimulation
-1.67
± 11.02
Change in the NIH Tool Box List Sorting Working Memory MeasurePrimary· 6 weeks
Improvement in executive function in participants will be assessed by determining if subjects randomized to iTBS show significant increases in their NIH Toolbox list sorting working memory test from baseline to the end of 6 weeks, compared to those randomized to sham.
NIH Tool box list sorting working memory test is a validated instrument measuring working memory.
The age corrected standard score is used, for which the normative mean is 100 and the standard deviation is 15. This score compares the score of the test taker to those in the NIH tool box nationally representative sample at the sa
Group
Value
95% CI
Active iTBS Treatment
-0.88
± 10.77
Sham Stimulation
-7.00
± 14.22
Connectivity Change Within the CNN, Fronto-parietal NetworkPrimary· 6 weeks
We will test the effects of iTBS on functional connectivity within the CNN ( fronto-parietal network) in depressed older adults obtained using resting state fMRI measuring BOLD signal in the brain.
Depressed older adults randomized to iTBS versus sham will have a significant increase in functional connectivity within the fronto-parietal network from baseline to week 6.
Group
Value
95% CI
Active iTBS Treatment
0.0059
± 0.0295
Sham Stimulation
0.0153
± 0.0347
Connectivity Change Within the CNN, Cingulo Opercular NetworkPrimary· 6 weeks
We will test the effects of iTBS on functional connectivity within the CNN cingulo opercular network in depressed older adults obtained using resting state fMRI measuring bold signal in the brain.
Depressed older adults randomized to iTBS versus sham will have a significant increase in functional connectivity within the cingulo-opercular network from baseline to week 6.
Group
Value
95% CI
Active iTBS Treatment
-0.0070
± 0.0329
Sham Stimulation
0.0076
± 0.0578
Sponsor's own description
Executive function deficits are common in late life depression (LLD) and are associated with resistance to antidepressants, poor quality of life, considerable disability and increased suicidal risk. This study uses a novel type of Transcranial Magnetic Stimulation called intermittent Theta Burst Stimulation (iTBS). iTBS delivers high frequency (50Hz) magnetic pulses in "bursts" of 3 stimuli. It is posited that this intervention induces plasticity in the human cortex. Theoretical and empirical evidence from research studies informs that iTBS can improve depression and executive deficits, however, this has not been examined in older adults.
This project examines iTBS's ability to improve depression and executive impairment in LLD. It also tests the effects of iTBS on brain connectivity within the Cognitive Control Network (CCN). This study will enhance understanding of LLD, providing critical pilot data to develop future randomized controlled clinical trials.
Both active and sham interventions are administered sequentially to the left and right dorso-lateral prefrontal cortex. The total stimulation time is about 7 minutes. These interventions are administered for 6 weeks (Monday-Friday). 20 subjects will be randomized. Changes in mood from baseline to the end of study are measured with the Montgomery-Asberg Depression Rating Scale. Executive function at baseline and end of study are evaluated with the National Institutes of Health Toolbox executive domain battery. Safety assessments include: the 21 item Scale for suicidal ideation SSI. The frequency, intensity and burden of side effects rating (FIBSER) and the Altman Self Rating Mania scale (ASRM). Ancillary depression measures include the Quick Inventory of Depressive Symptoms (QIDS) and the Clinical Global Impression of Improvement scale.
Subjects undergo functional Magnetic Resonance Imaging (fMRI) before and after the study interventions to test the effects of iTBS on the brain's functional connectivity.
This research will provide meaningful information about the effects of iTBS on mood and executive function in older adults as well as information regarding its effects on brain function. Results of this pilot study will inform a grant submission and allow investigators to calculate power for a definitive randomized controlled clinical trial to test the efficacy of iTBS versus placebo.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Sponsor: as reported to ClinicalTrials.gov by Washington University School of Medicine
Last refreshed: 6 July 2022
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