Accelerated Theta Burst Stimulation for Inpatients With Bipolar Disorder
|ClinicalTrials.gov Identifier: NCT04058249|
Recruitment Status : Not yet recruiting
First Posted : August 15, 2019
Last Update Posted : August 15, 2019
|Condition or disease||Intervention/treatment||Phase|
|Bipolar Disorder, Manic Bipolar Disorder I Bipolar II Disorder||Device: Accelerated intermittent theta-burst stimulation over right DLPFC||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Accelerated Theta Burst Stimulation for Inpatients With Bipolar Disorder|
|Estimated Study Start Date :||November 1, 2019|
|Estimated Primary Completion Date :||December 1, 2022|
|Estimated Study Completion Date :||December 1, 2023|
|Experimental: Right DLPFC aiTBS stimulation||
Device: Accelerated intermittent theta-burst stimulation over right DLPFC
All participants will receive accelerated intermittent theta-burst stimulation to the right DLPFC. Stimulation intensity will be standardized at 90% of resting motor threshold adjust to the skull to cortical surface distance.
Stimulation will be delivered to right-DLPFC using the Brainsway stimulator.
- Change from baseline Young Mania Rating Scale (YMRS) [ Time Frame: Baseline and immediate post-treatment ]
The Young Mania Rating Scale (YMRS) is one of the most frequently utilized rating scales to assess manic symptoms. The scale has 11 items and is based on the patient's subjective report of his or her clinical condition.
There are four items that are graded on a 0 to 8 scale (irritability, speech, thought content, and disruptive/aggressive behavior), while the remaining seven items are graded on a 0 to 4 scale. These four items are given twice the weight of the others to compensate for poor cooperation from severely ill patients.
Typical YMRS baseline scores can vary a lot. They depend on the patients' clinical features such as mania (YMRS = 12), depression (YMRS = 3), or euthymia (YMRS = 2).
- Change from baseline Montgomery Asberg Depression Rating Scale (MADRS) [ Time Frame: Baseline and immediate post-treatment ]
A ten item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders.
The MADRS uses a 0 to 6 severity scale, scored following the interview. Scoring/Interpretation: Higher scores indicate increasing depressive symptoms. ... Cut-off points include: 0 to 6 - symptom absent, 7 to 19 - mild depression, 30 to 34 - moderate, 35 to 60 - severe depression.
- Change from baseline functional connectivity as measured by MR imaging [ Time Frame: Baseline and immediate post-treatment ]Pre- and post resting state functional connectivity and structural T1-weighted MRI scans to determine the anti-correlated LDLPFC and SCC treatment location. The identified cluster with the greatest anti-correlation between the LDLPFC and SCC will have been utilized for the targeted aiTBS treatment. This algorithm will have also been applied to the post-imaging sessions to give measurements of voxel-wise blood flow in this anti-correlation targeted brain ROI.
- Change from baseline Hamilton Rating Scale for Depression (HAM-6) [ Time Frame: Baseline and immediate post-treatment ]A 6-item clinical assessment measuring depressive symptoms. Scores range from 0-24 with scores >5 indicating clinical levels of depressive symptoms.
- Change from baseline Beck Depression Inventory (BDI-II) [ Time Frame: Baseline and immediate post-treatment ]
The Beck Depression Inventory (BDI-II) is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression. BDI-II items are rated on a 4-point scale ranging from 0 to 3 based on severity of each item. The maximum total score is 63.
Scores: 0-13= minimal depression, 14-19=mild depression, 20-28=moderate depression, 29-63=severe depression
- Change in Scale of Suicidal Ideation (SSI) score [ Time Frame: Baseline and immediate post-treatment ]
19-item clinician administered assessment to measure the intensity, pervasiveness, and characteristics of suicidal ideation in adults.
Scores range from 0-38, with a score higher than 6, indicating active suicidal ideation.
- Change in baseline Altman Self-Rating Mania Scale (ASRM) [ Time Frame: Baseline and immediate post-treatment ]
The ASRM is a 5-item self rating mania scale, designed to assess the presence and/or severity of manic symptoms.
A score of 6 or higher indicates a high probability of a manic or hypomanic condition A score of 6 or higher may indicate a need for treatment and/or further diagnostic workup A score of 5 or lower is less likely to be associated with significant symptoms of mania
- Change from baseline Internal State Scale (ISS) [ Time Frame: Baseline and immediate post-treatment ]
Independent assessment of manic and depressive symptoms by self- rating scale characteristics and implications for the study of mania.
The ISS contains a series of visual analogue scale (VAS) items consisting of statement followed by a by eleven "bins" (equivalent to 0-10, 11-20, …91-100). In Likert-based scoring, the first bin is scored as zero, the second as 10, and so on to theeleventh bin which is scored as 100.
>155: (Hypo)Mania >155: Mixed State <155: Euthymia <155: Depression
- Change in NIH Cognitive Toolbox performance [ Time Frame: Baseline and immediate post-treatment ]Neurocognitive assessments delivered through an iPad app
- Change in heart rate variability [ Time Frame: Baseline and immediate post-treatment ]Polar H10 heart rate monitor will be used to measure heart rate variability
- Change in Temporal Experience of Pleasure Scale (TEPS) [ Time Frame: Baseline and immediate post-treatment ]
The Temporal Experience of Pleasure Scale (TEPS) is a measure specifically designed to capture the anticipatory and consummatory facets of pleasure.
TEPS is an 18-item questionnaire. Each item is scored from 0 "very false for me" to 6 "very true for me". Total score ranges from 0 to 108.
- Change in the Quality of Life Enjoyment and Satisfaction Questionnaire-short form score (Q-LES-Q-SF) [ Time Frame: Baseline and immediate post-treatment ]
15-item self-report questionnaire where each item is scored from very poor=1 to very good=5.
The scoring of the Q-LES-Q-SF involves summing only the first 14 items to yield a raw total score.
The last two items are not included in the total score but are stand-alone items.
The raw total score ranges from 14 (min) to 70 (max).
- Biomarker analysis in patient blood samples [ Time Frame: Baseline and immediate post-treatment ]Blood (plasma, DNA, RNA) samples will be collected before and immediately after treatment to identify changes in potential biomarkers of mania/hypomania and treatment response such as inflammatory cytokines. This analysis is exploratory.
- Saliva cortisol levels [ Time Frame: Baseline and immediate post-treatment ]
Saliva samples will be collected before and immediately after after stimulation. Saliva collection is performed by registered study personnel.
Saliva samples will be analyzed by our collaborators at the Open Medicine Institute. Specifically, saliva samples will be analyzed for cortisol levels.
- Biomarker analysis in patient stool samples [ Time Frame: Baseline and immediate post-treatment ]
Stool samples will be collected before and immediately after stimulation. Stool collection is performed by registered hospital nurses.
Stool samples will be analyzed by our collaborators at the Open Medicine Institute. Microbiota composition e.g. Clostridium, Bacteroides, and Prevotella levels will be analyzed as microbiota influences individual differences in health and disease including psychiatric disorders.
All analyses of stool samples will be conducted in the Open Medicine Institute.
- Change in resting-state recordings and TMS-evoked potentials in EEG data. [ Time Frame: Baseline and immediate post-treatment ]EEG recordings will be made before and after the treatment course to differences in EEG data associated with hypomania/mania and treatment response (e.g. amplitude & latency of tms-evoked potentials (TEPs), spatio-temporal distribution of TEPs and resting-state connectivity)
- Change in Columbia Suicide Severity Rating Scale (C-CSSRS), self-report version [ Time Frame: Baseline and immediate post-treatment ]
A self-report measure of the Columbia Suicide Severity Rating Scale (C-CSSRS). This questionnaire was developed to rate suicidal ideation and behavior.
It rates a person's degree of suicidal ideation on a scale, ranging from "wish to be dead" to "active suicidal ideation with specific plan and intent and behaviors.
The scale identifies specific behaviors which may be indicative of a person's intent to complete suicide. An person exhibiting even a single behavior identified by the scale was 8 to 10 times more likely to complete suicide.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04058249
|Contact: Romina Nejad, MScemail@example.com|
|United States, California|
|Stanford Hospital||Not yet recruiting|
|Palo Alto, California, United States, 94304|
|Contact: Nolan R Williams, MD firstname.lastname@example.org|