Traumatic Brain InjuryCOST-TBINCT01596569
Combined Transcranial Magnetic Stimulation and Cognitive Treatment in Blast Traumatic Brain Injury
A study testing Repetitive Transcranial Magnetic Stimulation (rTMS) and Cognitive Intervention in people with Traumatic Brain Injury and Cognitive Dysfunction, run by Boston Medical Center at 2 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 21 to 50 years
- Conditions the study is for
- Traumatic Brain Injury, Cognitive Dysfunction, Blast Injury
- What is being tested?
- Repetitive Transcranial Magnetic Stimulation (rTMS) and Cognitive Intervention
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2012to 18 Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Evidence of penetrating head injury
- History of previous neurological diagnosis
- History of previous psychotic disorder prior to the blast exposure
- Hearing or vision impairment
Trial locations and contacts
2 sites in 1 country.
United States2 sites
VA Boston Healthcare System
Boston, Massachusetts, 02130
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
Official title: Combining Cognitive Treatment With Noninvasive Brain Stimulation in Blast TBI
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).
Read the detailed description
The most common blast-induced traumatic brain injury (bTBI)-associated problems are cognitive deficits, such as executive functioning and memory. This study evaluates a combined rehabilitation program: transcranial magnetic stimulation (TMS) and cognitive therapy for treatment of patients with bTBI. TMS is a noninvasive way of stimulating the brain, which is not painful and does not involve any needles or any form of surgery. It acts by delivering a magnetic stimulation to a particular brain region. Half of the study participants will receive cognitive intervention with active TMS, and a control group will receive cognitive intervention with sham TMS. This study takes place in Boston, Massachusetts: at the VA Boston Healthcare System and Beth Israel Deaconess Medical Center.
- Conditions
- Traumatic Brain Injury, Cognitive Dysfunction, Blast Injury
- Being tested
- Repetitive Transcranial Magnetic Stimulation (rTMS), Cognitive Intervention
- Keywords
- Blast Traumatic Brain Injury, Cognitive Rehabilitation, Transcranial Magnetic Stimulation, Combined Treatment
- Medical subject headings
- Brain Injuries, Traumatic, Cognitive Dysfunction, Blast Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repetitive Transcranial Magnetic Stimulation (rTMS)Device
Also called Transcranial Magnetic Stimulation, Noninvasive Brain Stimulation, Magstim Corporation
Daily rTMS treatment for one week. Sham TMS participants receive the same study procedures as patients receiving active TMS.
Cognitive InterventionBehavioural
Also called Cognitive Rehabilitation, Cognitive Training
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.
| Study group | Role | What they receive |
|---|---|---|
| Active TMS and Cognitive Intervention | Active comparator | Active 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). Receives: Device: Repetitive Transcranial Magnetic Stimulation (rTMS); Behavioral: Cognitive Intervention |
| Sham TMS and Cognitive Intervention: | Sham comparator | Sham 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). Receives: Device: Repetitive Transcranial Magnetic Stimulation (rTMS); Behavioral: Cognitive Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
Secondary outcomes (2)
Daily life and functional outcome
Dysexecutive Questionnaire (DEX) is a 20-item self-report measure of real-life deficits relevant to cognitive/executive function that measures four domains: emotional, motivational, behavioral and cognitive. All items are rates in terms of frequency on a 5-point scale: 0 (never), 1(occasionally), 2 (sometimes), 3 (fairly often), 4 (very often). Scores are summed and the total scores range from 0 to 80, with higher scores indicating greater problems with executive functioning.
Measured: 4 weeks
PTSD symptoms
Military version (PCL-M) 17-item self-report measure that assesses PTSD symptoms. Each item is scored on the frequency of the problem from 1 to 5 where 1= not at all and 5= extremely. A total score is calculated and lower scores are more favorable..
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2012 (estimated)
- Study startMay 2012
- Primary completion18 Nov 2017
- Study completion18 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by Boston Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Research Resources (NCRR)
- Responsible party
- Principal investigator, Yelena Bogdanova, PhD, Boston Medical Center
- Investigators
- Yelena Bogdanova, PhD, Principal investigator, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01596569
- Sponsor's protocol ID
- H-29706
- Other IDs
- UL1RR025771
- Acronym
- COST-TBI
- Status last verified
- Oct 2018
- First submitted
- 7 May 2012
- Last updated
- 18 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 22350691
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combining Cognitive Treatment With Noninvasive Brain Stimulation in Blast TBI
- ClinicalTrials.gov ID
- NCT01596569
- Acronym / sponsor ID
- COST-TBI / H-29706
- Conditions
- Traumatic Brain Injury, Cognitive Dysfunction, Blast Injury
- Keywords
- Blast Traumatic Brain Injury, Cognitive Rehabilitation, Transcranial Magnetic Stimulation, Combined Treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Collaborators
- National Center for Research Resources (NCRR)
- Study start
- May 2012 (actual)
- Primary completion
- 18 Nov 2017 (actual)
- Study completion
- 18 Nov 2017 (actual)
- First posted
- 11 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
The most common blast-induced traumatic brain injury (bTBI)-associated problems are cognitive deficits, such as executive functioning and memory. This study evaluates a combined rehabilitation program: transcranial magnetic stimulation (TMS) and cognitive therapy for treatment of patients with bTBI. TMS is a noninvasive way of stimulating the brain, which is not painful and does not involve any needles or any form of surgery. It acts by delivering a magnetic stimulation to a particular brain region. Half of the study participants will receive cognitive intervention with active TMS, and a control group will receive cognitive intervention with sham TMS. This study takes place in Boston, Massachusetts: at the VA Boston Healthcare System and Beth Israel Deaconess Medical Center.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active TMS and Cognitive Intervention | Active comparator | Device: Repetitive Transcranial Magnetic Stimulation (rTMS), Behavioral: Cognitive InterventionActive 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 comparator | Device: Repetitive Transcranial Magnetic Stimulation (rTMS), Behavioral: Cognitive InterventionSham 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). |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Evidence of penetrating head injury
- History of previous neurological diagnosis
- History of previous psychotic disorder prior to the blast exposure
- Hearing or vision impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Repetitive Transcranial Magnetic Stimulation (rTMS)Also: Transcranial Magnetic Stimulation, Noninvasive Brain Stimulation, Magstim CorporationDaily rTMS treatment for one week. Sham TMS participants receive the same study procedures as patients receiving active TMS. | Device | Active TMS and Cognitive Intervention, Sham TMS and Cognitive Intervention: |
| Cognitive InterventionAlso: Cognitive Rehabilitation, Cognitive TrainingCognitive 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. | Behavioural | Active TMS and Cognitive Intervention, Sham TMS and Cognitive Intervention: |
Primary outcome
Post concussive symptoms in TBI
Time frame: 4 weeks
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.
2 secondary outcomes
Daily life and functional outcome
Time frame: 4 weeks
PTSD symptoms
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2018.
- Background: PubMed 22350691Bogdanova 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.
- Individual participant dataSharing planned: No
Related trials for Traumatic Brain Injury
Active, not recruitingObservational study
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
Traumatic Brain Injury, Post-traumatic Epilepsy
Enrolling by invitationPhase 1
Pilot Safety and Exploratory Efficacy of PSC-05 for the Treatment of Chronic Mild Traumatic Brain Injury
Mild Traumatic Brain Injury
RecruitingObservational study
Intracranial Pressure Monitoring in Moderate Traumatic Brain Injury
Moderate Traumatic Brain Injury
Not yet recruitingPhase 1
Nanopulse Laser Therapy
TBI (Traumatic Brain Injury)
RecruitingObservational study
Effect of Different Intravenous Fluids on Post-operative Chronic Subdural Hematoma Size and Recurrence
Chronic Subdural Hematoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yelena Bogdanova, PhD principal investigator
Boston University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repetitive Transcranial Magnetic Stimulation (rTMS) and Cognitive Intervention in people with Traumatic Brain Injury and Cognitive Dysfunction, run by Boston Medical Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post concussive symptoms in TBI (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01596569, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2018.