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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

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and rating at 8 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Hamilton Rating Scale for Depression

Secondary outcome measures

D-KEFS Color Word Interference Test

D-KEFS Trail Making Test

Glasgow Outcome Scale - Extended

+13 more

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of California, San DiegoLead Sponsor

1,122 Previous Clinical Trials

1,520,972 Total Patients Enrolled

29 Trials studying Depression

56,106 Patients Enrolled for Depression

San Diego Veterans Healthcare SystemFED

34 Previous Clinical Trials

3,834 Total Patients Enrolled

2 Trials studying Depression

190 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

Media Library

iTBS (Neuromodulation) Clinical Trial Eligibility Overview. Trial Name: NCT05682677 — N/A

Depression Research Study Groups: PACT+iTBS, PACT+sham iTBS

Depression Clinical Trial 2023: iTBS Highlights & Side Effects. Trial Name: NCT05682677 — N/A

iTBS (Neuromodulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05682677 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research endeavor have an age restriction, and if so, is it over 50 years of age?

"This medical trial is seeking out participants aged 18 to 65."

Answered by AI

Are patients able to enroll in this experiment currently?

"No, according to clinicaltrials.gov this trial is no longer actively accepting participants as of 1/11/2023. Even though enrollment has closed for this study, there are still over 1500 other medical trials that require subjects at the present moment."

Answered by AI

Is there any possibility of me joining this medical trial?

"This trial is open to 72 individuals from 18-65 years old suffering from depression. To be eligible, they must meet the following prerequisites: male or female of any race and ethnicity; military personnel currently in treatment at NMCSD or civilians receiving care at UCSD Health; mild traumatic brain injury within 3 months before enrollment with confirmation via DoD/VA criteria along with OSU TBI-ID method; moderate to severe Major Depressive Episode as per MINI interview (HAMD-17 score >18); 6 weeks on stable psychiatric medication without expected changes during study period; no contraindications for transcranial magnetic stimulation"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Combined Neuromodulation and Cognitive Training for Post-mTBI Depression

Elizabeth Twamley 2023. "Combined Neuromodulation and Cognitive Training for Post-mTBI Depression". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05682677.

All > Depression Anaheim > Transcranial Magnetic Stimulation