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Neuromodulation
Neuromodulation + Cognitive Training for Post-Concussion Depression
N/A
Recruiting
Led By Elizabeth Twamley, PhD
Research Sponsored by University of California, San Diego
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up rating at 8 weeks
Summary
This trial will test if a combo of cognitive training and electrical brain stimulation can help depression in people with mild TBI. Participants will receive 20 sessions over 4 weeks & be assessed at baseline, 2wks, 4wks & 8wks.
Who is the study for?
This trial is for Service Members, Veterans, and civilians aged 18-65 with post-mTBI depression who can commit to the treatment schedule. They must have moderate to severe depressive symptoms, no MRI or TMS contraindications, stable psychiatric medications for 6 weeks, and meet criteria for a current Major Depressive Episode.
What is being tested?
The study tests if Personalized Augmented Cognitive Training (PACT) combined with intermittent theta burst stimulation (iTBS) improves depression in those with mild TBI more than PACT with sham iTBS. Participants will undergo 20 sessions over four weeks and be assessed up to eight weeks.
What are the potential side effects?
Potential side effects of iTBS may include discomfort at the stimulation site, headache, lightheadedness, or seizures; however specific side effects related to this trial's interventions are not detailed.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ rating at 8 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~rating at 8 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Patient Global Impression of Change
Traumatic Brain Injury Quality of Life
UCSD Performance-Based Skills Assessment-Brief
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: PACT+iTBSExperimental Treatment2 Interventions
Personalized, Augmented Cognitive Training (PACT; 6 sessions over 4 weeks) + intermittent theta burst stimulation (iTBS; 20 sessions over 4 weeks)
Group II: PACT+sham iTBSPlacebo Group2 Interventions
Personalized, Augmented Cognitive Training (PACT; 6 sessions over 4 weeks) + sham intermittent theta burst stimulation (sham iTBS; 20 sessions over 4 weeks)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
iTBS
2019
Completed Phase 3
~640
Find a Location
Who is running the clinical trial?
University of California, San DiegoLead Sponsor
1,180 Previous Clinical Trials
1,574,984 Total Patients Enrolled
37 Trials studying Depression
59,400 Patients Enrolled for Depression
San Diego Veterans Healthcare SystemFED
37 Previous Clinical Trials
5,543 Total Patients Enrolled
3 Trials studying Depression
790 Patients Enrolled for Depression
Elizabeth Twamley, PhDPrincipal InvestigatorUC San Diego
2 Previous Clinical Trials
76 Total Patients Enrolled
1 Trials studying Depression
12 Patients Enrolled for Depression
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 18 and 65 years old.I am either male or female.I do not have any conditions that would stop me from participating in treatments or assessments.I am taking 2 mg or more of lorazepam daily or I am on anticonvulsant medication.I have tried rTMS, iTBS, or ECT treatments without success.I am on medication that increases my risk of seizures.I am currently experiencing a major depressive episode.I had a mild traumatic brain injury more than 3 months ago.My psychiatric medications have been stable for 6 weeks and won't change during the study.I can make my own decisions and agree to participate in the study.I have completed more than 4 cognitive rehab sessions in the past 3 years.
Research Study Groups:
This trial has the following groups:- Group 1: PACT+iTBS
- Group 2: PACT+sham iTBS
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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