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Combined Neuromodulation and Cognitive Training for Post-mTBI Depression

Primary Purpose

Depression, Mild Traumatic Brain Injury, Concussion, Brain

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
iTBS
sham iTBS
Personalized, Augmented Cognitive Training (PACT)
Sponsored by
University of California, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring brain stimulation, neuromodulation, transcranial magnetic stimulation, theta burst stimulation, TMS, TBS, rTMS, iTBS, cognitive training, cognitive rehabilitation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Male or female All racial and ethnic groups Ages 18 to 65 Military service members receiving treatment at NMCSD or civilians receiving treatment at UCSD Health History of mild TBI (as defined by the DoD/VA criteria used in conjunction with the OSU TBI-ID method) over 3 months prior to study entry Meets criteria for current Major Depressive Episode within the context of Major Depressive Disorder, per MINI Score of 18 or higher on the HAMD-17, indicating moderate to severe depressive symptoms Stable on psychiatric medications for 6 weeks, with no changes to psychiatric medications expected during the study period No contraindications to TMS (passes the TMS Adult Safety Screening questionnaire) No contraindications to MRI (passes MRI safety screening questionnaire) Able to commit to the treatment schedule Able to complete assessment procedures in English Intact decision-making capacity and ability to provide voluntary informed consent Exclusion Criteria: History of moderate, severe, or penetrating TBI History of other neurological condition unrelated to TBI, including but not limited to: conditions associated with increased intracranial pressure; space occupying brain lesions; cerebral aneurysm; stroke; transient ischemic attack within past two years; Parkinson's disease; Huntington's disease; dementia; multiple sclerosis; history of brain surgery; epilepsy; seizure except those therapeutically induced by electroconvulsive therapy (ECT) or a febrile seizure of infancy Implanted medical devices including cardiac pacemaker, medication pump, aneurysm clip, shunt, stimulator, cochlear implant, electrodes, or any other metal object within or near the head (excluding the mouth) that cannot be safely removed Active manic or psychotic illness per MINI Current substance use disorder per MINI Current active suicidal or homicidal ideation Pregnant or intending to become pregnant within the study period; breastfeeding Other sensory conditions or illnesses precluding participation in assessments or treatment Current dose of lorazepam 2 mg or greater daily (or benzodiazepine equivalent) or any anticonvulsant due to the potential to limit iTBS efficacy Taking medication that lowers seizure threshold Previous failed treatment with rTMS, iTBS, or ECT Completed >4 sessions of cognitive rehabilitation within the last 3 years

Sites / Locations

  • UCSDRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

PACT+iTBS

PACT+sham iTBS

Arm Description

Personalized, Augmented Cognitive Training (PACT; 6 sessions over 4 weeks) + intermittent theta burst stimulation (iTBS; 20 sessions over 4 weeks)

Personalized, Augmented Cognitive Training (PACT; 6 sessions over 4 weeks) + sham intermittent theta burst stimulation (sham iTBS; 20 sessions over 4 weeks)

Outcomes

Primary Outcome Measures

Hamilton Rating Scale for Depression

Secondary Outcome Measures

Patient Health Questionnaire-9
Neurobehavioral Symptom Inventory
PTSD Checklist for DSM-5
Headache Impact Test
Pittsburgh Sleep Quality Index
WHO Disability Assessment Schedule
Glasgow Outcome Scale - Extended
PROMIS Cognitive Function Abilities Short Form
Patient Global Impression of Change
This measure asks the participant to rate their status since the start of the study from 1 (very much improved) to 7 (very much worse)
Traumatic Brain Injury Quality of Life
The Traumatic Brain Injury Quality of Life The Traumatic Brain Injury Quality of Life measurement system (TBI-QOL) is a TBI-specific extension of the NIH PROMIS and Neuro-QoL measures that includes 20 items measuring physical, emotional, social, and cognitive domains
D-KEFS Trail Making Test
D-KEFS Color Word Interference Test
WMS-IV Digit Span
WAIS-IV Processing Speed
Hopkins Verbal Learning Test - Revised
UCSD Performance-Based Skills Assessment-Brief
The UCSD Performance-Based Skills Assessment-Brief is a performance-based measure that uses role play scenarios to assess capacity for financial and communication tasks.

Full Information

First Posted
January 4, 2023
Last Updated
September 19, 2023
Sponsor
University of California, San Diego
Collaborators
San Diego Veterans Healthcare System
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1. Study Identification

Unique Protocol Identification Number
NCT05682677
Brief Title
Combined Neuromodulation and Cognitive Training for Post-mTBI Depression
Official Title
Combined Neuromodulation and Cognitive Training for Post-mTBI Depression
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 19, 2023 (Actual)
Primary Completion Date
June 30, 2026 (Anticipated)
Study Completion Date
June 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego
Collaborators
San Diego Veterans Healthcare System

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
The primary goal of this clinical trial is to evaluate whether Personalized Augmented Cognitive Training (PACT) plus intermittent theta burst stimulation (iTBS) is effective for treating depression in Service Members, Veterans, and civilians who have sustained a mild TBI. Participants will receive PACT plus 20 sessions of iTBS or sham iTBS over 4 weeks. Assessments will occur at baseline, 2 weeks, 4 weeks, and 8 weeks. Researchers will compare the PACT+iTBS group to the PACT+sham iTBS group to see if PACT+iTBS is associated with more depression improvement.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Mild Traumatic Brain Injury, Concussion, Brain
Keywords
brain stimulation, neuromodulation, transcranial magnetic stimulation, theta burst stimulation, TMS, TBS, rTMS, iTBS, cognitive training, cognitive rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PACT+iTBS
Arm Type
Experimental
Arm Description
Personalized, Augmented Cognitive Training (PACT; 6 sessions over 4 weeks) + intermittent theta burst stimulation (iTBS; 20 sessions over 4 weeks)
Arm Title
PACT+sham iTBS
Arm Type
Sham Comparator
Arm Description
Personalized, Augmented Cognitive Training (PACT; 6 sessions over 4 weeks) + sham intermittent theta burst stimulation (sham iTBS; 20 sessions over 4 weeks)
Intervention Type
Device
Intervention Name(s)
iTBS
Intervention Description
iTBS over the left dorsolateral prefrontal cortex
Intervention Type
Device
Intervention Name(s)
sham iTBS
Intervention Description
sham iTBS over the left dorsolateral prefrontal cortex
Intervention Type
Behavioral
Intervention Name(s)
Personalized, Augmented Cognitive Training (PACT)
Intervention Description
6 sessions of PACT
Primary Outcome Measure Information:
Title
Hamilton Rating Scale for Depression
Time Frame
change over 8 weeks
Secondary Outcome Measure Information:
Title
Patient Health Questionnaire-9
Time Frame
change over 8 weeks
Title
Neurobehavioral Symptom Inventory
Time Frame
change over 8 weeks
Title
PTSD Checklist for DSM-5
Time Frame
change over 8 weeks
Title
Headache Impact Test
Time Frame
change over 8 weeks
Title
Pittsburgh Sleep Quality Index
Time Frame
change over 8 weeks
Title
WHO Disability Assessment Schedule
Time Frame
change over 8 weeks
Title
Glasgow Outcome Scale - Extended
Time Frame
change over 8 weeks
Title
PROMIS Cognitive Function Abilities Short Form
Time Frame
change over 8 weeks
Title
Patient Global Impression of Change
Description
This measure asks the participant to rate their status since the start of the study from 1 (very much improved) to 7 (very much worse)
Time Frame
rating at 8 weeks
Title
Traumatic Brain Injury Quality of Life
Description
The Traumatic Brain Injury Quality of Life The Traumatic Brain Injury Quality of Life measurement system (TBI-QOL) is a TBI-specific extension of the NIH PROMIS and Neuro-QoL measures that includes 20 items measuring physical, emotional, social, and cognitive domains
Time Frame
change over 8 weeks
Title
D-KEFS Trail Making Test
Time Frame
change over 8 weeks
Title
D-KEFS Color Word Interference Test
Time Frame
change over 8 weeks
Title
WMS-IV Digit Span
Time Frame
change over 8 weeks
Title
WAIS-IV Processing Speed
Time Frame
change over 8 weeks
Title
Hopkins Verbal Learning Test - Revised
Time Frame
change over 8 weeks
Title
UCSD Performance-Based Skills Assessment-Brief
Description
The UCSD Performance-Based Skills Assessment-Brief is a performance-based measure that uses role play scenarios to assess capacity for financial and communication tasks.
Time Frame
change over 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female All racial and ethnic groups Ages 18 to 65 Military service members receiving treatment at NMCSD or civilians receiving treatment at UCSD Health History of mild TBI (as defined by the DoD/VA criteria used in conjunction with the OSU TBI-ID method) over 3 months prior to study entry Meets criteria for current Major Depressive Episode within the context of Major Depressive Disorder, per MINI Score of 18 or higher on the HAMD-17, indicating moderate to severe depressive symptoms Stable on psychiatric medications for 6 weeks, with no changes to psychiatric medications expected during the study period No contraindications to TMS (passes the TMS Adult Safety Screening questionnaire) No contraindications to MRI (passes MRI safety screening questionnaire) Able to commit to the treatment schedule Able to complete assessment procedures in English Intact decision-making capacity and ability to provide voluntary informed consent Exclusion Criteria: History of moderate, severe, or penetrating TBI History of other neurological condition unrelated to TBI, including but not limited to: conditions associated with increased intracranial pressure; space occupying brain lesions; cerebral aneurysm; stroke; transient ischemic attack within past two years; Parkinson's disease; Huntington's disease; dementia; multiple sclerosis; history of brain surgery; epilepsy; seizure except those therapeutically induced by electroconvulsive therapy (ECT) or a febrile seizure of infancy Implanted medical devices including cardiac pacemaker, medication pump, aneurysm clip, shunt, stimulator, cochlear implant, electrodes, or any other metal object within or near the head (excluding the mouth) that cannot be safely removed Active manic or psychotic illness per MINI Current substance use disorder per MINI Current active suicidal or homicidal ideation Pregnant or intending to become pregnant within the study period; breastfeeding Other sensory conditions or illnesses precluding participation in assessments or treatment Current dose of lorazepam 2 mg or greater daily (or benzodiazepine equivalent) or any anticonvulsant due to the potential to limit iTBS efficacy Taking medication that lowers seizure threshold Previous failed treatment with rTMS, iTBS, or ECT Completed >4 sessions of cognitive rehabilitation within the last 3 years
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michelle Schy
Phone
858-642-3848
Email
mschy@health.ucsd.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Janae Wyckoff
Phone
858-642-3848
Email
jwyckoff@health.ucsd.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth Twamley, PhD
Organizational Affiliation
UC San Diego
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCSD
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michelle Schy
Phone
858-642-3848
Email
mschy@health.ucsd.edu
First Name & Middle Initial & Last Name & Degree
Janae Wyckoff
Phone
858-642-3848
Email
jwyckoff@health.ucsd.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
IPD will be available via FITBIR.
IPD Sharing Time Frame
Following study completion; deidentified data available indefinitely.
IPD Sharing Access Criteria
Via FITBIR request.
IPD Sharing URL
https://fitbir.nih.gov

Learn more about this trial

Combined Neuromodulation and Cognitive Training for Post-mTBI Depression

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