Combined Transcranial Magnetic Stimulation and Cognitive Treatment in Blast Traumatic Brain Injury
COST-TBI
Combining Cognitive Treatment With Noninvasive Brain Stimulation in Blast TBI
2 other identifiers
interventional
15
1 country
2
Brief Summary
This study investigates the efficacy of a novel neurorehabilitation program combining noninvasive brain stimulation (transcranial magnetic stimulation or TMS) and cognitive therapy, on cognitive function and quality of life in individuals with blast-induced traumatic brain injury (bTBI).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2012
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2012
CompletedFirst Submitted
Initial submission to the registry
May 7, 2012
CompletedFirst Posted
Study publicly available on registry
May 11, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 18, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
November 18, 2017
CompletedOctober 18, 2018
October 1, 2018
5.6 years
May 7, 2012
October 16, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Post concussive symptoms in TBI
Neurobehavioral Symptoms Inventory (NSI) is a 22-item measure that assesses the post-concussive symptoms in patients with TBI.The NSI asks the patient to rate each of the symptoms according to how much the symptom has disturbed him/her using a five point scale. Patient ratings are based on descriptions of the frequency of the symptom, the extent to which the symptom disrupts the patient's activities, and the patient's perceived need for help with the symptom. A total score will be summated. Lower scores are more favorable.
4 weeks
Secondary Outcomes (2)
Daily life and functional outcome
4 weeks
PTSD symptoms
4 weeks
Study Arms (2)
Active TMS and Cognitive Intervention
ACTIVE COMPARATORActive TMS and Cognitive Intervention: Repetitive Transcranial Magnetic Stimulation (rTMS) and Cognitive intervention designed specifically to address the most common cognitive deficits (executive function and memory).
Sham TMS and Cognitive Intervention:
SHAM COMPARATORSham TMS and Cognitive Intervention: Repetitive Transcranial Magnetic Stimulation (rTMS) and Cognitive intervention designed specifically to address the most common cognitive deficits (executive function and memory).
Interventions
Daily rTMS treatment for one week. Sham TMS participants receive the same study procedures as patients receiving active TMS.
Cognitive intervention designed specifically to address the most common cognitive deficits (executive function and memory) in bTBI. All participants receive weekly cognitive treatment sessions for 10 weeks.
Eligibility Criteria
You may qualify if:
- OEF/OIF active-duty personnel or veterans exposed to blast
- Meets criteria for mild TBI
- LOC of 30 min or less
- Age: 21-50
- Primary language is English
You may not qualify if:
- Evidence of penetrating head injury
- History of previous neurological diagnosis
- History of previous psychotic disorder prior to the blast exposure
- Hearing or vision impairment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
VA Boston Healthcare System
Boston, Massachusetts, 02130, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Related Publications (1)
Bogdanova Y, Verfaellie M. Cognitive sequelae of blast-induced traumatic brain injury: recovery and rehabilitation. Neuropsychol Rev. 2012 Mar;22(1):4-20. doi: 10.1007/s11065-012-9192-3. Epub 2012 Feb 17.
PMID: 22350691BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yelena Bogdanova, PhD
Boston University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- DEVICE FEASIBILITY
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- BUMC Faculty
Study Record Dates
First Submitted
May 7, 2012
First Posted
May 11, 2012
Study Start
May 1, 2012
Primary Completion
November 18, 2017
Study Completion
November 18, 2017
Last Updated
October 18, 2018
Record last verified: 2018-10
Data Sharing
- IPD Sharing
- Will not share