TBI (Traumatic Brain Injury)NCT02881151
Deep Brain Stimulation for the Treatment of Traumatic Brain Injury
A study testing Deep brain stimulation in people with TBI (Traumatic Brain Injury), run by Jaimie M. Henderson at 1 site in United States.
Trial summary
This study involves the treatment of cognitive impairment secondary to moderate to severe brain injury using central thalamic deep brain stimulation. Although all patients will receive stimulation continuously through a surgically implanted pacemaker-like device, half of the patients will have the device deactivated… Read more about this study
- Who is it for?
- Ages 22 to 60 years
- Conditions the study is for
- TBI (Traumatic Brain Injury)
- What is being tested?
- Deep brain stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Apr 2017to 4 May 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 22 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- History of moderate to severe TBI based on worst GCS score within first 48 hours of injury (acceptable GCS range = 3-12)
- Age 22-60
- At least 24 months from date of onset
- Fluent in English and able to independently provide consent
- Rating of upper moderate disability to lower good recovery on the Glasgow Outcome Scale-Extended (GOSE) at time of enrollment (acceptable GOSE range 5-7)
- Failure to return to pre-injury level of vocational or educational function
- Either receiving no CNS stimulants or other medications known to affect cognitive function, or on stable doses of these medications for the last three months
Who cannot join
- History of major developmental, neurologic, psychiatric or substance use disorder with evidence of disability prior to onset of TBI
- Major medical co-morbidities including: end stage renal failure, severe heart failure, coagulopathy, severe respiratory problems, severe liver failure, uncontrolled hypertension or other significant medical co morbidities
- Have had a documented seizure within 3 months of study screening (subjects may re-screen if seizure free after initial screen failure)
- Malignancy with < 5 years life expectancy
- Untreated / uncontrolled (severe at the time of enrollment) depression or other psychiatric disorder
- Women of childbearing age who do not regularly use an accepted contraceptive method
Show all 14Show fewer
- Inability to stop anticoagulation therapy or platelet anti-aggregation therapy before, during and after surgery
- Previous DBS or other brain implants
- Previous ablative intracranial surgery
- Implantable hardware not compatible with MRI
- Condition requiring diathermy after DBS implantation
- Hardware, lesions or other factors limiting placement of electrodes in optimal target location in the judgment of the operating surgeon
- Concurrent enrollment in any other clinical trial
- Any condition or finding that, in the judgment of the PI, significantly increases risk or significantly reduces the likelihood of benefit from DBS
Trial locations and contacts
1 site in 1 country.
About this study
Official title: CT-DBS for Traumatic Brain Injury Using the Medtronic Activa PC+S System
This study involves the treatment of cognitive impairment secondary to moderate to severe brain injury using central thalamic deep brain stimulation. Although all patients will receive stimulation continuously through a surgically implanted pacemaker-like device, half of the patients will have the device deactivated during a blinded assessment phase. The device will be reactivated following this assessment and patients will have the option to continue stimulation in an open-label continuation.
Read the detailed description
This preliminary safety study evaluates the use of the Medtronic Activa PC+S system and Medtronic Nexus-E system for central thalamic deep brain stimulation (CT-DBS) in the treatment of cognitive impairment secondary to traumatic brain injury (TBI). It involves a neurosurgical procedure in which electrodes are implanted in the brain, connected to an implanted pacemaker-like device in the chest. The proposed study, if successful, will provide supporting evidence for the development of a novel therapeutic approach utilizing CT-DBS to improve these enduring cognitive impairments arising in persons with multi-focal structural brain injuries. This research will address the critical gap of the lack of any available treatments. CT-DBS targets well-defined neuronal populations within the central thalamus that have known anatomical and physiological specializations, which not only provide a key role in arousal regulation during cognitively-mediated behaviors, but also exhibit a particular vulnerability to dysfunction in the setting of multi-focal, non-selective brain injuries.
Our proposed study aims to support development of CT-DBS as a novel therapeutic avenue for accessing cognitive reserve in patients with acquired brain injuries. In the proposed feasibility study of 6 subjects at a single investigational site, we will test the safety of CT-DBS in the severe traumatic brain injury (STBI) population with GOSE 6-7 level recovery and collect data to establish the translation of preclinical studies into human application of CT-DBS.
- Conditions
- TBI (Traumatic Brain Injury)
- Being tested
- Deep brain stimulation
- Keywords
- Deep brain stimulation, DBS, Central thalamus, TBI, Traumatic brain injury
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep brain stimulationDevice
Also called DBS, CT-DBS, Central Thalamic DBS
Delivery of continuous, low-voltage electrical pulses to deep portions of the brain via an implantable pacemaker-like device.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Subjects will be treated with deep brain stimulation throughout the study, with the exception of a brief, 21 day blinded withdrawal phase that will be undertaken to assess for any possible therapeutic effect. Receives: Device: Deep brain stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change in Trail Making Test Part B Time to Completion
The Trail Making Test is a measure of attention, speed and mental flexibility. It also tests spatial organization, visual pursuits, recall, and recognition. Part A requires the individual to draw lines to connect 25 encircled numbers distributed on a page. Part A tests visual scanning, numeric sequencing, and visuomotor speed. Part B is similar except the person must alternate between numbers and letters and is believed to be more difficult and takes longer to complete. Part B tests cognitive demands including visual motor and visual spatial abilities and mental flexibility. Both sections are timed and the score represents the amount of time required to complete the task. Lower scores (shorter times) correspond to a better outcome.
Measured: Pre-surgery baseline to treatment phase end (up to 197 days)
Secondary outcomes (11)
Percent Change in Trail Making Test Part A Time to Completion
The Trail Making Test is a measure of attention, speed and mental flexibility. It also tests spatial organization, visual pursuits, recall, and recognition. Part A requires the individual to draw lines to connect 25 encircled numbers distributed on a page. Part A tests visual scanning, numeric sequencing, and visuomotor speed. Part B is similar except the person must alternate between numbers and letters and is believed to be more difficult and takes longer to complete. Part B tests cognitive demands including visual motor and visual spatial abilities and mental flexibility. Both sections are timed and the score represents the amount of time required to complete the task. Lower scores (shorter times) correspond to a better outcome.
Measured: Pre-surgery baseline to treatment phase end (up to 197 days)
Percent Change in Traumatic Brain Injury Quality of Life - Executive Function Short Form (TBI-QOL) Scale Score
The TBI-QOL was developed as a comprehensive patient-reported outcomes (PRO) measurement system specifically for individuals with TBI. It consists of 20 independent calibrated item banks and 2 uncalibrated scales that measure physical, emotional, cognitive, and social aspects of health-related quality of life. We will administer the short form (6-10 questions each) of the TBI-QOL Fatigue, Attention/Concentration, and Executive Function subscales. Executive Function score range: 10-50, higher scores correspond to better executive function.
Measured: Pre-surgery baseline to treatment phase end (up to 197 days)
Percent Change Traumatic Brain Injury Quality of Life - Attention/Concentration Short Form Scale Score
The TBI-QOL was developed as a comprehensive patient-reported outcomes (PRO) measurement system specifically for individuals with TBI. It consists of 20 independent calibrated item banks and 2 uncalibrated scales that measure physical, emotional, cognitive, and social aspects of health-related quality of life. We will administer the short form (6-10 questions each) of the TBI-QOL Fatigue, Attention/Concentration, and Executive Function subscales. Attention/Concentration score range: 6-30, higher scores correspond to better attention and concentration.
Measured: Pre-surgery baseline to treatment phase end (up to 197 days)
Percent Change in Traumatic Brain Injury Quality of Life - Fatigue Short Form Scale Score
The TBI-QOL was developed as a comprehensive patient-reported outcomes (PRO) measurement system specifically for individuals with TBI. It consists of 20 independent calibrated item banks and 2 uncalibrated scales that measure physical, emotional, cognitive, and social aspects of health-related quality of life. We will administer the short form (6-10 questions each) of the TBI-QOL Fatigue, Attention/Concentration, and Executive Function subscales. Fatigue score range: 10-50, lower scores correspond to less fatigue.
Measured: Pre-surgery baseline to treatment phase end (up to 197 days)
Percent Change in Rivermead Post-Concussion Symptom Questionnaire Scale Score
The Rivermead PCS Questionnaire (RPQ) was originally developed as a measure of severity of symptoms following mild TBI. It consists of 16 post-concussion symptoms including headaches, dizziness, nausea/vomiting, noise sensitivity, sleep disturbance, fatigue, irritability, feeling depressed/tearful, feeling frustrated/ impatient, forgetfulness, poor concentration, taking longer to think, blurred vision, light sensitivity, double vision and restlessness. In the original version of the RPQ, participants are asked to rate the degree (on a scale of 0 to 4) to which a particular symptom has been absent or a mild, moderate or severe problem over the previous 24 hours compared with premorbid levels. Score range: 0-64, lower scores correspond to fewer symptoms
Measured: Pre-surgery baseline to treatment phase end (up to 197 days)
Percent Change in Ruff 2 and 7 Automatic Detection Speed Score
The Ruff 2 \& 7 Test was developed to measure two aspects of visual attention: sustained attention (ability to maintain consistent performance level over time) and selective attention (ability to select relevant stimuli while ignoring distractors). The test consists of a series of 20 trials of a visual search and cancellation task. The respondent detects and marks through all occurrences of the two target digits: "2" and "7." In the 10 Automatic Detection trials, the target digits are embedded among alphabetical letters that serve as distractors. In the 10 Controlled Search trials, the target digits are embedded among other numbers that serve as distractors. Correct hits and errors are counted for each trial and serve as the basis for scoring the test. Speed scores reflect the total number of correctly identified targets (hits). Score range: 0 to 300, with higher numbers representing more correctly identified targets within the allotted time (5 minutes)
Measured: Pre-surgery baseline to treatment phase end (up to 197 days)
Percent Change in Ruff 2 and 7 Automatic Detection Accuracy Score
The Ruff 2 \& 7 Test was developed to measure two aspects of visual attention: sustained attention (ability to maintain consistent performance level over time) and selective attention (ability to select relevant stimuli while ignoring distractors). The test consists of a series of 20 trials of a visual search and cancellation task. The respondent detects and marks through all occurrences of the two target digits: "2" and "7." In the 10 Automatic Detection trials, the target digits are embedded among alphabetical letters that serve as distractors. In the 10 Controlled Search trials, the target digits are embedded among other numbers that serve as distractors. Correct hits and errors are counted for each trial and serve as the basis for scoring the test. Accuracy scores evaluate the number of targets identified in relation to the number of possible targets (n=300), expressed as a percentage. Higher scores represent higher accuracy of target identification.
Measured: Pre-surgery baseline to treatment phase end (up to 197 days)
Percent Change in Ruff 2 and 7 Controlled Search Speed Score
The Ruff 2 \& 7 Test was developed to measure two aspects of visual attention: sustained attention (ability to maintain consistent performance level over time) and selective attention (ability to select relevant stimuli while ignoring distractors). The test consists of a series of 20 trials of a visual search and cancellation task. The respondent detects and marks through all occurrences of the two target digits: "2" and "7." In the 10 Automatic Detection trials, the target digits are embedded among alphabetical letters that serve as distractors. In the 10 Controlled Search trials, the target digits are embedded among other numbers that serve as distractors. Correct hits and errors are counted for each trial and serve as the basis for scoring the test. Speed scores reflect the total number of correctly identified targets (hits). Score range: 0 to 300, with higher numbers representing more correctly identified targets within the allotted time (5 minutes)
Measured: Pre-surgery baseline to treatment phase end (up to 197 days)
Percent Change in Ruff 2 and 7 Controlled Search Accuracy Score
The Ruff 2 \& 7 Test was developed to measure two aspects of visual attention: sustained attention (ability to maintain consistent performance level over time) and selective attention (ability to select relevant stimuli while ignoring distractors). The test consists of a series of 20 trials of a visual search and cancellation task. The respondent detects and marks through all occurrences of the two target digits: "2" and "7." In the 10 Automatic Detection trials, the target digits are embedded among alphabetical letters that serve as distractors. In the 10 Controlled Search trials, the target digits are embedded among other numbers that serve as distractors. Correct hits and errors are counted for each trial and serve as the basis for scoring the test. Accuracy scores evaluate the number of targets identified in relation to the number of possible targets (n=300), expressed as a percentage. Higher scores represent higher accuracy of target identification.
Measured: Pre-surgery baseline to treatment phase end (up to 197 days)
Percent Change in Patient Health Questionnaire - 9 Scale Score.
The Participant Health Questionnaire 9 is a standardized assessment instrument designed to screen, diagnose, monitor, and measure the severity of depression. Score range: 0 to 27, lower scores correspond to better health outcomes.
Measured: Pre-surgery baseline to treatment phase end (up to 197 days)
Number of Participants With ≥1 Point Increase in Glasgow Outcome Scale - Extended Scale Score
The Glasgow Outcome Scale Extended (GOS-E) is a measure of disability and handicap intended for use following head injury. The GOS-E subdivides the upper three categories of the original Glasgow Outcome Scale (GOS), severe disability, moderate disability and good recovery, into an eight-category scale: 1 = dead, 2 = vegetative state, 3 = lower severe disability, 4 = upper severe disability, 5 = lower moderate disability, 6 = upper moderate disability, 7 = lower good recovery, and 8 = upper good recovery to provide more detailed assessment of the functional effects of the injury. A structured interview has been developed to standardize assignment of an outcome category (Wilson et al. 1998). Increase of 1 point on this scale represents a meaningful change in health outcome.
Measured: Pre-surgery baseline to treatment phase end (up to 197 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2016 (estimated)
- Study start20 Apr 2017
- Primary completion13 Oct 2021
- Study completion4 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for TBI (Traumatic Brain Injury)Studies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jaimie M. Henderson
- Sponsor type
- University, hospital or other
- Collaborators
- Weill Medical College of Cornell University, University of Utah, Harvard Medical School (HMS and HSDM), The Cleveland Clinic
- Responsible party
- Sponsor-investigator, Jaimie M. Henderson, Stanford University
- Investigators
- Jaimie M Henderson, MD, Study director, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02881151
- Sponsor's protocol ID
- 37280
- Status last verified
- Nov 2022
- First submitted
- 22 Aug 2016
- Last updated
- 23 Dec 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Wilson JT, Pettigrew LE, Teasdale GM. Structured interviews for the Glasgow Outcome Scale and the extended Glasgow Outcome Scale: guidelines for their use. J Neurotrauma. 1998 Aug;15(8):573-85. doi: 10.1089/neu.1998.15.573.
PubMed 9726257Schiff ND, Giacino JT, Butson CR, Choi EY, Baker JL, O'Sullivan KP, Janson AP, Bergin M, Bronte-Stewart HM, Chua J, DeGeorge L, Dikmen S, Fogarty A, Gerber LM, Krel M, Maldonado J, Radovan M, Shah SA, Su J, Temkin N, Tourdias T, Victor JD, Waters A, Kolakowsky-Hayner SA, Fins JJ, Machado AG, Rutt BK, Henderson JM. Thalamic deep brain stimulation in traumatic brain injury: a phase 1, randomized feasibility study. Nat Med. 2023 Dec;29(12):3162-3174. doi: 10.1038/s41591-023-02638-4. Epub 2023 Dec 4.
PubMed 38049620
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CT-DBS for Traumatic Brain Injury Using the Medtronic Activa PC+S System
- ClinicalTrials.gov ID
- NCT02881151
- Acronym / sponsor ID
- 37280
- Conditions
- TBI (Traumatic Brain Injury)
- Keywords
- Deep brain stimulation, DBS, Central thalamus, TBI, Traumatic brain injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Jaimie M. HendersonUniversity, hospital or other
- Collaborators
- Weill Medical College of Cornell University, University of Utah, Harvard Medical School (HMS and HSDM), The Cleveland Clinic
- Study start
- 20 Apr 2017 (actual)
- Primary completion
- 13 Oct 2021 (actual)
- Study completion
- 4 May 2022 (actual)
- First posted
- 26 Aug 2016 (estimated)
- Results
- Posted 23 Dec 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study involves the treatment of cognitive impairment secondary to moderate to severe brain injury using central thalamic deep brain stimulation. Although all patients will receive stimulation continuously through a surgically implanted pacemaker-like device, half of the patients will have the device deactivated during a blinded assessment phase. The device will be reactivated following this assessment and patients will have the option to continue stimulation in an open-label continuation.
Detailed description
This preliminary safety study evaluates the use of the Medtronic Activa PC+S system and Medtronic Nexus-E system for central thalamic deep brain stimulation (CT-DBS) in the treatment of cognitive impairment secondary to traumatic brain injury (TBI). It involves a neurosurgical procedure in which electrodes are implanted in the brain, connected to an implanted pacemaker-like device in the chest. The proposed study, if successful, will provide supporting evidence for the development of a novel therapeutic approach utilizing CT-DBS to improve these enduring cognitive impairments arising in persons with multi-focal structural brain injuries. This research will address the critical gap of the lack of any available treatments. CT-DBS targets well-defined neuronal populations within the central thalamus that have known anatomical and physiological specializations, which not only provide a key role in arousal regulation during cognitively-mediated behaviors, but also exhibit a particular vulnerability to dysfunction in the setting of multi-focal, non-selective brain injuries.
Our proposed study aims to support development of CT-DBS as a novel therapeutic avenue for accessing cognitive reserve in patients with acquired brain injuries. In the proposed feasibility study of 6 subjects at a single investigational site, we will test the safety of CT-DBS in the severe traumatic brain injury (STBI) population with GOSE 6-7 level recovery and collect data to establish the translation of preclinical studies into human application of CT-DBS.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: Deep brain stimulationSubjects will be treated with deep brain stimulation throughout the study, with the exception of a brief, 21 day blinded withdrawal phase that will be undertaken to assess for any possible therapeutic effect. |
Who may qualify
- Ages
- 22 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- History of moderate to severe TBI based on worst GCS score within first 48 hours of injury (acceptable GCS range = 3-12)
- Age 22-60
- At least 24 months from date of onset
- Fluent in English and able to independently provide consent
- Rating of upper moderate disability to lower good recovery on the Glasgow Outcome Scale-Extended (GOSE) at time of enrollment (acceptable GOSE range 5-7)
Key exclusion criteria (14 listed)
- History of major developmental, neurologic, psychiatric or substance use disorder with evidence of disability prior to onset of TBI
- Major medical co-morbidities including: end stage renal failure, severe heart failure, coagulopathy, severe respiratory problems, severe liver failure, uncontrolled hypertension or other significant medical co morbidities
- Have had a documented seizure within 3 months of study screening (subjects may re-screen if seizure free after initial screen failure)
- Malignancy with < 5 years life expectancy
- Untreated / uncontrolled (severe at the time of enrollment) depression or other psychiatric disorder
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 |
|---|---|---|
| Deep brain stimulationAlso: DBS, CT-DBS, Central Thalamic DBSDelivery of continuous, low-voltage electrical pulses to deep portions of the brain via an implantable pacemaker-like device. | Device | Treatment |
Primary outcome
Percent Change in Trail Making Test Part B Time to Completion
Time frame: Pre-surgery baseline to treatment phase end (up to 197 days)
The Trail Making Test is a measure of attention, speed and mental flexibility. It also tests spatial organization, visual pursuits, recall, and recognition. Part A requires the individual to draw lines to connect 25 encircled numbers distributed on a page. Part A tests visual scanning, numeric sequencing, and visuomotor speed. Part B is similar except the person must alternate between numbers and letters and is believed to be more difficult and takes longer to complete. Part B tests cognitive demands including visual motor and visual spatial abilities and mental flexibility. Both sections are timed and the score represents the amount of time required to complete the task. Lower scores (shorter times) correspond to a better outcome.
11 secondary outcomes
Percent Change in Trail Making Test Part A Time to Completion
Time frame: Pre-surgery baseline to treatment phase end (up to 197 days)
Percent Change in Traumatic Brain Injury Quality of Life - Executive Function Short Form (TBI-QOL) Scale Score
Time frame: Pre-surgery baseline to treatment phase end (up to 197 days)
Percent Change Traumatic Brain Injury Quality of Life - Attention/Concentration Short Form Scale Score
Time frame: Pre-surgery baseline to treatment phase end (up to 197 days)
Percent Change in Traumatic Brain Injury Quality of Life - Fatigue Short Form Scale Score
Time frame: Pre-surgery baseline to treatment phase end (up to 197 days)
Percent Change in Rivermead Post-Concussion Symptom Questionnaire Scale Score
Time frame: Pre-surgery baseline to treatment phase end (up to 197 days)
Percent Change in Ruff 2 and 7 Automatic Detection Speed Score
Time frame: Pre-surgery baseline to treatment phase end (up to 197 days)
Percent Change in Ruff 2 and 7 Automatic Detection Accuracy Score
Time frame: Pre-surgery baseline to treatment phase end (up to 197 days)
Percent Change in Ruff 2 and 7 Controlled Search Speed Score
Time frame: Pre-surgery baseline to treatment phase end (up to 197 days)
Percent Change in Ruff 2 and 7 Controlled Search Accuracy Score
Time frame: Pre-surgery baseline to treatment phase end (up to 197 days)
Percent Change in Patient Health Questionnaire - 9 Scale Score.
Time frame: Pre-surgery baseline to treatment phase end (up to 197 days)
Number of Participants With ≥1 Point Increase in Glasgow Outcome Scale - Extended Scale Score
Time frame: Pre-surgery baseline to treatment phase end (up to 197 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 9726257Wilson JT, Pettigrew LE, Teasdale GM. Structured interviews for the Glasgow Outcome Scale and the extended Glasgow Outcome Scale: guidelines for their use. J Neurotrauma. 1998 Aug;15(8):573-85. doi: 10.1089/neu.1998.15.573.
- Derived from this study: PubMed 38049620Schiff ND, Giacino JT, Butson CR, Choi EY, Baker JL, O'Sullivan KP, Janson AP, Bergin M, Bronte-Stewart HM, Chua J, DeGeorge L, Dikmen S, Fogarty A, Gerber LM, Krel M, Maldonado J, Radovan M, Shah SA, Su J, Temkin N, Tourdias T, Victor JD, Waters A, Kolakowsky-Hayner SA, Fins JJ, Machado AG, Rutt BK, Henderson JM. Thalamic deep brain stimulation in traumatic brain injury: a phase 1, randomized feasibility study. Nat Med. 2023 Dec;29(12):3162-3174. doi: 10.1038/s41591-023-02638-4. Epub 2023 Dec 4.
- Individual participant dataSharing planned: No
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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.
Jaimie M Henderson, MD study director
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deep brain stimulation in people with TBI (Traumatic Brain Injury), run by Jaimie M. Henderson at 1 site 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 7 inclusion and 14 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 23 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
Yes. Results are posted in the registry (first posted 23 Dec 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percent Change in Trail Making Test Part B Time to Completion (time frame: Pre-surgery baseline to treatment phase end (up to 197 days)). 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 NCT02881151, which also lists 2 linked publications.
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 23 Dec 2022.