Back to resultsAccelerated Intermittent Theta Burst Stimulation for Depressive Symptoms (aTBS)
Primary Purpose
Depression and Suicide
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dorsolateral Prefrontal Cortex Accelerated Theta Burst Stimulation
Anterior Cingulate Cortex Accelerated Theta Burst Stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Depression and Suicide
Eligibility Criteria
Inclusion Criteria:
- Over 18 years old
- Able to read, understand, and provide written, dated informed consent prior to screening. Participants will be deemed likely to comply with study protocol and communicate with study personnel about adverse events and other clinically important information.
- Currently diagnosed with Major Depressive Disorder (MDD) and/or in a current major depressive episode, according to the criteria defined in the Diagnosis and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR)
- Currently an inpatient at Stanford Hospital
- Meet the threshold on the total HAMD17 score of >/=20 at screening/baseline.
- Qualifies and has access to outpatient rTMS treatment
Exclusion Criteria:
- Any structural lesion e.g. structural neurological condition, more subcortical lesions than would be expected for age, stroke effecting stimulated area or connected areas or any other clinically significant abnormality that might affect safety, study participation, or confound interpretation of study results.
- Metal implant in brain (e.g. deep brain stimulation), cardiac pacemaker, or cochlear
- History of epilepsy/ seizures (including history of withdrawal/ provoked seizures)
- Shrapnel or any ferromagnetic item in the head
- Pregnancy
- Autism Spectrum disorder
- Active substance use (<1 week) or intoxication verified by toxicology screen--of cocaine, amphetamines, benzodiazepines
- Any current or past history of any physical condition which in the investigator's opinion might put the subject at risk or interfere with study results interpretation
- Cognitive impairment (including dementia)
- Current severe insomnia (must sleep a minimum of 4 hours the night before stimulation)
- Current mania
- Current unmanageable psychosis
- IQ <70
- Showing symptoms of withdrawal from alcohol or benzodiazepines
- Parkinsonism or other movement d/o determined by PI to interfere with treatment
- More subcortical lesions than would be expected for age or a stroke effecting stimulated area or connected areas.
- Any other indication the PI feels would comprise data.
Sites / Locations
- Stanford Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Dorsolateral Prefrontal Cortex
Anterior Cingulate Cortex
Arm Description
The accelerated theta burst stimulation protocol will be applied to the left dorsolateral prefrontal cortex (L-DLPFC), for 10 sessions per day for up to 5 days.
The accelerated theta burst stimulation protocol will be applied to the left anterior cingulate cortex (ACC), for 10 sessions per day for up to 5 days.
Outcomes
Primary Outcome Measures
Change in Montgomery Asberg Depression Rating Scale (MADRS) Score
A 10-item clinician-administered scale, designed to be particularly sensitive to antidepressant treatment effects in patients with major depression. Severity gradations for the MADRS have been proposed: 9-17 = mild depression, 18-34 = moderate depression, and ≥ 35 = severe depression. Scores range from 0-60 (higher scores are more symptomatic).
Response is defined as a 50% reduction or greater in MADRS score compared to baseline. Remission is defined as a MADRS score of <10.
Data are presented as a raw score point change.
Secondary Outcome Measures
Change in Scale of Suicidal Ideation (SSI) Score
19-item clinician administered assessment to measure the intensity, pervasiveness, and characteristics of suicidal ideation in adults.
Scores range from 0-38. Higher scores indicate more suicidality.
Data are presented as a raw score point change.
Change in Hamilton Rating Scale for Depression Six Item (HAMD-6) Score
Clinical assessment measuring depressive symptoms. Scores range from 0-24 with scores >5 indicating clinical levels of depressive symptoms (higher scores are more symptomatic).
Data are presented as a raw score point change.
Change in Young Mania Rating Scale (YMRS)
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).
Data are presented as a raw score point change.
Change in Beck Depression Inventory II (BDI-II)
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.
Data are presented as a raw score point change.
Change in Quick Inventory Depressive Scale-Self Reported (QIDS) Score
Self-report measure of depressive symptoms. The questionnaire consists of 16 questions. Each question can score between 0 to 4 points.
Severity of depression is determined as follows: 0=None, 1=Mild, 2=Moderate, 3=Severe, 4=Very Severe.
Total scores range from 0-27. Total scores: 0-5= no depression, 6-10= mild depression, 11-15= moderate depression, 16-20= severe depression, 21-27= very severe depression.
The total score is obtained by adding the scores for each of the nine symptom domains of the DSM-IV MDD criteria: depressed mood, loss of interest or pleasure, concentration/decision making, self-outlook, suicidal ideation, energy/fatigability, sleep, weight/appetite change, and psychomotor changes (Rush et al. 2003).
Data are presented as a raw score point change.
Change in Pittsburgh Insomnia Rating Scale-20 Item Version (PIRS-20) Score
Self-report, 20 item scale to determine patient's insomnia level.
Each question can be scored between 0-3. 0=not bothered at all
slightly bothered moderately bothered severely bothered
Total score is calculated by adding up all questions (i.e. Q1+Q2+...Q20). One missing item is allowed, pro-rate if missing one item....i.e. (sum/count)*20.
Minimum Score = 0 (good); Maximum Score = 60 (bad).
Data are presented as a raw score point change.
Change in Resting-state Recordings and TMS-evoked Potentials in EEG Data.
For the first and last stimulation session, EEG recording will be made before (resting-state EEG) and during (TMS-evoked potentials) the stimulation.
Biomarker Analysis in Patient Blood (Plasma) Samples
Blood (plasma) samples will be collected before and one month after stimulation. Blood collection is conducted by the registered hospital phlebotomist (following same protocol of a routine blood test).
Blood samples will be analyzed by our collaborators at the Open Medicine Institute. Specifically, samples will be used for DNA/RNA extraction and analyses will be done to determine potential gene targets. Presence of inflammatory markers (cytokines) will also be determined.
All analyses of blood samples will be conducted in the Open Medicine Institute.
Biomarker Analysis in Patient Stool Samples
Stool samples will be collected before and one month after stimulation. Stool collection is performed by registered hospital nurses.
Stool samples will be analyzed by our collaborators at the Open Medicine Institute. Specifically, stool samples will be analyzed for potential biomarkers in the gut microbiome.
All analyses of stool samples will be conducted in the Open Medicine Institute.
Biomarker Analysis in Patient Saliva Samples
Saliva samples will be collected before and one month 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.
All analyses of stool samples will be conducted in the Open Medicine Institute.
Change in th Quality of Life Enjoyment and Satisfaction Questionnaire-short Form Score
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).
Change in Performance on the NIH Toolbox
Neurocognitive assessments delivered through an iPad app
Change in Immediate Mood Scaler (Ims-12) Depression Subscale Score
Immediate Mood Scaler (IMS) is a newly developed, iPad-deliverable 12-item self-report tool designed to capture current mood states with overall score, and depression and anxiety subscales. Individual item scores range from 1-7, with a total overall score range from 12-84.
Data are presented as a raw score point change in depression subscale score. The depression subscale scores range from 7-49 (higher score indicating worse depression).
Change in Heart Rate Variability
Measure presence of any change in heart rate variability.
Data is reported as a ratio of low frequency (LF) and high frequency (HF) (LF/HF FFT).
FFT: fast Fourier transform.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03601117
Brief Title
Accelerated Intermittent Theta Burst Stimulation for Depressive Symptoms
Acronym
aTBS
Official Title
Accelerated Intermittent Theta Burst Stimulation for Depressive Symptoms
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
July 1, 2018 (Actual)
Primary Completion Date
June 1, 2020 (Actual)
Study Completion Date
June 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study evaluates an accelerated schedule of theta-burst stimulation for depressive symptoms in psychiatric inpatients.
A small pilot study (n=22) will be carried out to demonstrate feasibility, using the FDA-approved stimulation site for depression treatment (L-DLPFC). Participants will be offered stimulation at the anterior cingulate cortex (ACC).
Detailed Description
This study intends to investigate whether modifying stimulation parameters enables typical 6-8 week long rTMS protocols to be compressed to only five days. The influence of this accelerated protocol on the length of patient stay in the hospital will be investigated.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression and Suicide
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A small pilot study (n=22) will be an open-label study in which all participants receive stimulation to the L-DLPFC to demonstrate feasibility of delivering this accelerated protocol on an inpatient unit.
For participants who do not respond to L-DLPFC stimulation, we will offer an alternative site, the ACC.
If patients are enrolled that have a psychiatric diagnosis other than MDD, scales measuring symptoms related to their other diagnosis/(es) will also be collected in addition to measuring change in depressive symptoms (see 'other pre-specified outcome measures' for a list of measures used to measure symptoms related to psychiatric diagnoses other than depression).
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dorsolateral Prefrontal Cortex
Arm Type
Experimental
Arm Description
The accelerated theta burst stimulation protocol will be applied to the left dorsolateral prefrontal cortex (L-DLPFC), for 10 sessions per day for up to 5 days.
Arm Title
Anterior Cingulate Cortex
Arm Type
Experimental
Arm Description
The accelerated theta burst stimulation protocol will be applied to the left anterior cingulate cortex (ACC), for 10 sessions per day for up to 5 days.
Intervention Type
Device
Intervention Name(s)
Dorsolateral Prefrontal Cortex Accelerated Theta Burst Stimulation
Intervention Description
Participants will receive iTBS (intermittent theta burst stimulation) to the left DLPFC.
Stimulation intensity will be standardized at 80% of resting motor threshold (adjusted for cortical depth).
Stimulation will be delivered using the Brainsway TMS system.
Intervention Type
Device
Intervention Name(s)
Anterior Cingulate Cortex Accelerated Theta Burst Stimulation
Intervention Description
Participants will receive iTBS (intermittent theta burst stimulation) to the anterior cingulate cortex (ACC).
Stimulation intensity will be standardized at 80% of resting motor threshold (adjusted for cortical depth).
Stimulation will be delivered using the Brainsway TMS system.
Primary Outcome Measure Information:
Title
Change in Montgomery Asberg Depression Rating Scale (MADRS) Score
Description
A 10-item clinician-administered scale, designed to be particularly sensitive to antidepressant treatment effects in patients with major depression. Severity gradations for the MADRS have been proposed: 9-17 = mild depression, 18-34 = moderate depression, and ≥ 35 = severe depression. Scores range from 0-60 (higher scores are more symptomatic).
Response is defined as a 50% reduction or greater in MADRS score compared to baseline. Remission is defined as a MADRS score of <10.
Data are presented as a raw score point change.
Time Frame
After all stimulation sessions have been completed (approximately 48 hours after the final session)
Secondary Outcome Measure Information:
Title
Change in Scale of Suicidal Ideation (SSI) Score
Description
19-item clinician administered assessment to measure the intensity, pervasiveness, and characteristics of suicidal ideation in adults.
Scores range from 0-38. Higher scores indicate more suicidality.
Data are presented as a raw score point change.
Time Frame
After all stimulation sessions have been completed (approximately 48 hours after the final session)
Title
Change in Hamilton Rating Scale for Depression Six Item (HAMD-6) Score
Description
Clinical assessment measuring depressive symptoms. Scores range from 0-24 with scores >5 indicating clinical levels of depressive symptoms (higher scores are more symptomatic).
Data are presented as a raw score point change.
Time Frame
After all stimulation sessions have been completed (approximately 48 hours after the final session)
Title
Change in Young Mania Rating Scale (YMRS)
Description
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).
Data are presented as a raw score point change.
Time Frame
After all stimulation sessions have been completed (approximately 48 hours after the final session)
Title
Change in Beck Depression Inventory II (BDI-II)
Description
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.
Data are presented as a raw score point change.
Time Frame
After all stimulation sessions have been completed (approximately 48 hours after the final session)
Title
Change in Quick Inventory Depressive Scale-Self Reported (QIDS) Score
Description
Self-report measure of depressive symptoms. The questionnaire consists of 16 questions. Each question can score between 0 to 4 points.
Severity of depression is determined as follows: 0=None, 1=Mild, 2=Moderate, 3=Severe, 4=Very Severe.
Total scores range from 0-27. Total scores: 0-5= no depression, 6-10= mild depression, 11-15= moderate depression, 16-20= severe depression, 21-27= very severe depression.
The total score is obtained by adding the scores for each of the nine symptom domains of the DSM-IV MDD criteria: depressed mood, loss of interest or pleasure, concentration/decision making, self-outlook, suicidal ideation, energy/fatigability, sleep, weight/appetite change, and psychomotor changes (Rush et al. 2003).
Data are presented as a raw score point change.
Time Frame
After all stimulation sessions have been completed (approximately 48 hours after the final session)
Title
Change in Pittsburgh Insomnia Rating Scale-20 Item Version (PIRS-20) Score
Description
Self-report, 20 item scale to determine patient's insomnia level.
Each question can be scored between 0-3. 0=not bothered at all
slightly bothered moderately bothered severely bothered
Total score is calculated by adding up all questions (i.e. Q1+Q2+...Q20). One missing item is allowed, pro-rate if missing one item....i.e. (sum/count)*20.
Minimum Score = 0 (good); Maximum Score = 60 (bad).
Data are presented as a raw score point change.
Time Frame
After all stimulation sessions have been completed (approximately 48 hours after the final session)
Title
Change in Resting-state Recordings and TMS-evoked Potentials in EEG Data.
Description
For the first and last stimulation session, EEG recording will be made before (resting-state EEG) and during (TMS-evoked potentials) the stimulation.
Time Frame
After all stimulation sessions have been completed (approximately 48 hours after the final session)
Title
Biomarker Analysis in Patient Blood (Plasma) Samples
Description
Blood (plasma) samples will be collected before and one month after stimulation. Blood collection is conducted by the registered hospital phlebotomist (following same protocol of a routine blood test).
Blood samples will be analyzed by our collaborators at the Open Medicine Institute. Specifically, samples will be used for DNA/RNA extraction and analyses will be done to determine potential gene targets. Presence of inflammatory markers (cytokines) will also be determined.
All analyses of blood samples will be conducted in the Open Medicine Institute.
Time Frame
After all stimulation sessions have been completed (approximately 48 hours after the final session)
Title
Biomarker Analysis in Patient Stool Samples
Description
Stool samples will be collected before and one month after stimulation. Stool collection is performed by registered hospital nurses.
Stool samples will be analyzed by our collaborators at the Open Medicine Institute. Specifically, stool samples will be analyzed for potential biomarkers in the gut microbiome.
All analyses of stool samples will be conducted in the Open Medicine Institute.
Time Frame
After all stimulation sessions have been completed (approximately 48 hours after the final session)
Title
Biomarker Analysis in Patient Saliva Samples
Description
Saliva samples will be collected before and one month 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.
All analyses of stool samples will be conducted in the Open Medicine Institute.
Time Frame
After all stimulation sessions have been completed (approximately 48 hours after the final session)
Title
Change in th Quality of Life Enjoyment and Satisfaction Questionnaire-short Form Score
Description
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).
Time Frame
After all stimulation sessions have been completed (approximately 48 hours after the final session)
Title
Change in Performance on the NIH Toolbox
Description
Neurocognitive assessments delivered through an iPad app
Time Frame
After all stimulation sessions have been completed (approximately 48 hours after the final session)
Title
Change in Immediate Mood Scaler (Ims-12) Depression Subscale Score
Description
Immediate Mood Scaler (IMS) is a newly developed, iPad-deliverable 12-item self-report tool designed to capture current mood states with overall score, and depression and anxiety subscales. Individual item scores range from 1-7, with a total overall score range from 12-84.
Data are presented as a raw score point change in depression subscale score. The depression subscale scores range from 7-49 (higher score indicating worse depression).
Time Frame
After all stimulation sessions have been completed (approximately 48 hours after the final session)
Title
Change in Heart Rate Variability
Description
Measure presence of any change in heart rate variability.
Data is reported as a ratio of low frequency (LF) and high frequency (HF) (LF/HF FFT).
FFT: fast Fourier transform.
Time Frame
After all stimulation sessions have been completed (approximately 48 hours after the final session)
Other Pre-specified Outcome Measures:
Title
Change in Alcohol Craving Questionnaire Score (Adapted for All Drug Use)
Description
If participants have a co-morbid diagnosis of drug abuse this self-report questionnaire will be used to monitor craving of their particular drug of abuse.
Time Frame
After all stimulation sessions have been completed (approximately 48 hours after the final session)
Title
Change in Borderline Evaluation Of Severity Over Time (BEST) Score
Description
If participants have a co-morbid diagnosis of borderline personality disorder this self-report questionnaire will be used to monitor symptoms.
Time Frame
After all stimulation sessions have been completed (approximately 48 hours after the final session)
Title
Change in Obsessive Compulsive Drinking Scale Score (Adapted for Use of Any Drug)
Description
If participants have a co-morbid diagnosis of drug abuse this self-report questionnaire will be used.
Time Frame
After all stimulation sessions have been completed (approximately 48 hours after the final session)
Title
Change in Average Weekly Substance Use
Description
If participants have a co-morbid diagnosis of drug abuse their reported average weekly substance use will be recorded.
Time Frame
After all stimulation sessions have been completed (approximately 48 hours after the final session)
Title
Change in Eating Disorder Examination Questionnaire (EDE-Q) Score
Description
If participants have a co-morbid diagnosis of an eating disorder, this self-report questionnaire will be used to monitor symptoms.
Time Frame
After all stimulation sessions have been completed (approximately 48 hours after the final session)
Title
Change in Generalized Anxiety Disorder 7-item (GAD-7) Score
Description
If participants have a co-morbid diagnosis of Anxiety, this self-report scale will be used to monitor anxiety symptoms.
Time Frame
After all stimulation sessions have been completed (approximately 48 hours after the final session)
Title
Change in Yale Brown Cornell Eating Disorder Scale (YBC-EDS) Score
Description
If participants have a co-morbid diagnosis of an eating disorder, this clinician-rated assessment will be used to monitor symptoms.
Time Frame
After all stimulation sessions have been completed (approximately 48 hours after the final session)
Title
Change in Massachusetts General Hospital (MGH) Hairpulling Scale Score (Edited so Can be Used With Any Impulse Disorder)
Description
If participants have a co-morbid diagnosis of an impulse disorder, this self-report questionnaire will be used to monitor symptoms.
Time Frame
After all stimulation sessions have been completed (approximately 48 hours after the final session)
Title
Change in Obsessive Compulsive Inventory (OCI) Score
Description
If participants have a co-morbid diagnosis of OCD, this self-report questionnaire will be used to monitor symptoms.
Time Frame
After all stimulation sessions have been completed (approximately 48 hours after the final session)
Title
Change in Yalebrown Obsessive Compulsive Scale (YBOCS) Score
Description
If participants have a co-morbid diagnosis of OCD, this clinician-rated scale will be used to monitor symptoms.
Time Frame
After all stimulation sessions have been completed (approximately 48 hours after the final session)
Title
Change in Numeric Rating Scale For Pain Score
Description
If participants have a co-morbid diagnosis of a pain disorder, this rating scale will be used to monitor symptoms.
Time Frame
After all stimulation sessions have been completed (approximately 48 hours after the final session)
Title
Change in Panic Disorder Severity Scale (PDSS) Score
Description
If participants have a co-morbid diagnosis of a panic disorder, this rating scale will be used to monitor symptoms.
Time Frame
Pre-treatment, after each day of stimulation and immediate post-treatmentAfter all stimulation sessions have been completed (approximately 48 hours after the final session)
Title
PTSD Checklist Civilian Version (PCL-C)
Description
If participants have a co-morbid diagnosis of PTSD, this self-report questionnaire will be used to monitor symptoms.
Time Frame
After all stimulation sessions have been completed (approximately 48 hours after the final session)
Title
Change in Calgary Depression Scale For Schizophrenia (CDSS) Score
Description
If participants have a co-morbid diagnosis of Schizophrenia, this assessment will be used to monitor symptoms.
Time Frame
After all stimulation sessions have been completed (approximately 48 hours after the final session)
Title
Change in the Positive And Negative Syndrome Scale (PANSS) Score
Description
If participants have a co-morbid diagnosis of Schizophrenia, this clinician-rated assessment will be used to monitor symptoms.
Time Frame
After all stimulation sessions have been completed (approximately 48 hours after the final session)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Over 18 years old
Able to read, understand, and provide written, dated informed consent prior to screening. Participants will be deemed likely to comply with study protocol and communicate with study personnel about adverse events and other clinically important information.
Currently diagnosed with Major Depressive Disorder (MDD) and/or in a current major depressive episode, according to the criteria defined in the Diagnosis and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR)
Currently an inpatient at Stanford Hospital
Meet the threshold on the total HAMD17 score of >/=20 at screening/baseline.
Qualifies and has access to outpatient rTMS treatment
Exclusion Criteria:
Any structural lesion e.g. structural neurological condition, more subcortical lesions than would be expected for age, stroke effecting stimulated area or connected areas or any other clinically significant abnormality that might affect safety, study participation, or confound interpretation of study results.
Metal implant in brain (e.g. deep brain stimulation), cardiac pacemaker, or cochlear
History of epilepsy/ seizures (including history of withdrawal/ provoked seizures)
Shrapnel or any ferromagnetic item in the head
Pregnancy
Autism Spectrum disorder
Active substance use (<1 week) or intoxication verified by toxicology screen--of cocaine, amphetamines, benzodiazepines
Any current or past history of any physical condition which in the investigator's opinion might put the subject at risk or interfere with study results interpretation
Cognitive impairment (including dementia)
Current severe insomnia (must sleep a minimum of 4 hours the night before stimulation)
Current mania
Current unmanageable psychosis
IQ <70
Showing symptoms of withdrawal from alcohol or benzodiazepines
Parkinsonism or other movement d/o determined by PI to interfere with treatment
More subcortical lesions than would be expected for age or a stroke effecting stimulated area or connected areas.
Any other indication the PI feels would comprise data.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nolan Williams, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford Hospital
City
Palo Alto
State/Province
California
ZIP/Postal Code
94305
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
20439832
Citation
George MS, Lisanby SH, Avery D, McDonald WM, Durkalski V, Pavlicova M, Anderson B, Nahas Z, Bulow P, Zarkowski P, Holtzheimer PE 3rd, Schwartz T, Sackeim HA. Daily left prefrontal transcranial magnetic stimulation therapy for major depressive disorder: a sham-controlled randomized trial. Arch Gen Psychiatry. 2010 May;67(5):507-16. doi: 10.1001/archgenpsychiatry.2010.46.
Results Reference
background
PubMed Identifier
8547583
Citation
George MS, Wassermann EM, Williams WA, Callahan A, Ketter TA, Basser P, Hallett M, Post RM. Daily repetitive transcranial magnetic stimulation (rTMS) improves mood in depression. Neuroreport. 1995 Oct 2;6(14):1853-6. doi: 10.1097/00001756-199510020-00008.
Results Reference
background
PubMed Identifier
8684201
Citation
Pascual-Leone A, Rubio B, Pallardo F, Catala MD. Rapid-rate transcranial magnetic stimulation of left dorsolateral prefrontal cortex in drug-resistant depression. Lancet. 1996 Jul 27;348(9022):233-7. doi: 10.1016/s0140-6736(96)01219-6.
Results Reference
background
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Accelerated Intermittent Theta Burst Stimulation for Depressive Symptoms
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