TBI (Traumatic Brain Injury)NCT05176392
Combined Transcranial Magnetic Stimulation and Therapy for MTBI Related Headaches
A study testing Active rTMS and Headache Management Therapy in people with TBI (Traumatic Brain Injury) and Headache, run by Veterans Medical Research Foundation at 1 site in United States.
Trial summary
This study will assess the combined effectiveness of repetitive transcranial magnetic stimulation (rTMS) and telehealth based therapy in helping manage mild traumatic brain injury (mTBI) related headaches. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- TBI (Traumatic Brain Injury), Headache, Depression
- What is being tested?
- Active rTMS and Headache Management Therapy
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2022to 31 Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mild Traumatic Brain Injury (mTBI)
- Chronic headaches > 3 months after injury
- Aged 18-65
- No prior TMS treatment
- Persistent Headaches with an intensity > 30 / 100
- No history of daily headache prior to mTBI
Who cannot join
- Pregnant
- Pacemaker or any metal in body that would prevent MRI
- History of dementia or major psychiatric disease, such as bipolar disorder or schizophrenia
- Presence of any other chronic neuropathic pain states
- History of seizure
- Pending litigation
Show all 9Show fewer
- Can't understand English
- History of chronic headache like migraine prior to mTBI
- Evidence in chart of exacerbation of depressive/anxiety symptoms, active substance dependence, suicidal intent or attempt within previous month
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
VA San Diego Healthcare System
San Diego, California, 92161
Caleb Lopez, BS, 858-552-8585 ext. 2638, caleb.lopez@va.gov
Albert Y Leung, MD
About this study
Official title: Combined Nonpharmacological Therapies for MTBI-Related Headaches
This study will assess the combined effectiveness of repetitive transcranial magnetic stimulation (rTMS) and telehealth based therapy in helping manage mild traumatic brain injury (mTBI) related headaches. The investigators hypothesize that active rTMS combined with telehealth therapy will provide marked reduction in mTBI related headaches and symptoms in comparison to their placebo counterparts.
Read the detailed description
This study will be enrolling a total of 240 veterans or active military over a 4 year period at the VA San Diego Healthcare System (VASDHS). Participants will be randomized into one of four groups:
Group A: active rTMS with telehealth headache management therapy Group B: active rTMS with telehealth headache education control Group C: sham rTMS with telehealth headache management therapy Group D: sham rTMS with telehealth headache education control
Individual participation will consist of 19 visits to the VASDHS and 11 telehealth sessions over the course of 6-7 months. The in person visits will be divided into the following phases:
- PRE-TREATMENT ASSESSMENTS PHASE (weeks 1-2) which consists of Visit 1 (Screening Visit) and Visit 2 (Baseline Assessments with MRI scan);
- INDUCTION TREATMENT PHASE (weeks 3-4) consists of Visits 3-12 (10 weekday neuronavigation guided rTMS sessions at >24 and <72 hours apart); and
- POST-TREATMENT ASSESSMENTS AND MAINTENANCE TREATMENT PHASE (weeks 5-24) consists of 4 initial biweekly post-induction treatment assessments and maintenance treatments (Visits 13-16)) and two additional monthly post-induction assessments and maintenance treatments (Visits 17-18) and one final study visit (Visit 19).
Eight weekly telehealth therapy/education sessions will be conducted from week 3 to 10 with additional three bolster sessions at 4 weeks apart. During the baseline and follow up visits, assessments will be conducted to evaluate headaches, neurobehavioral symptoms, depressive symptoms, post-concussion symptoms, and quality of life.
- Conditions
- TBI (Traumatic Brain Injury), Headache, Depression
- Being tested
- Active rTMS, Headache Management Therapy, Sham rTMS, Headache Education Control
- Keywords
- rTMS, transcranial magnetic stimulation, therapy
- Medical subject headings
- Brain Injuries, Traumatic, Headache, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active rTMSDevice
Active rTMS will be given at the left dorsolateral prefrontal cortex with a double blind TMS coil.
Headache Management TherapyBehavioural
Therapy will be provided on headache management.
Sham rTMSDevice
Sham rTMS will be given at the left dorsolateral prefrontal cortex. All parameters of the treatment will appear identical to the active treatment, with only the rTMS coil used to administer the treatment flipped 180 degrees to prevent stimulation.
Headache Education ControlBehavioural
In the control, educational sessions on headaches will be provided.
| Study group | Role | What they receive |
|---|---|---|
| Active rTMS with telehealth headache management therapy | Active comparator | Participants receive both active rTMS treatment at the left dorsolateral prefrontal cortex and therapy for headache management Receives: Device: Active rTMS; Behavioral: Headache Management Therapy |
| Active rTMS with telehealth headache education control | Other | Participants receive active rTMS treatment at the left dorsolateral prefrontal cortex and headache education Receives: Device: Active rTMS; Behavioral: Headache Education Control |
| Sham rTMS with telehealth headache management therapy | Other | Participants receive sham rTMS treatment at the left dorsolateral prefrontal cortex and therapy for headache management Receives: Behavioral: Headache Management Therapy; Device: Sham rTMS |
| Sham rTMS with telehealth headache education control | Sham comparator | Participants receive sham rTMS treatment at the left dorsolateral prefrontal cortex and headache education Receives: Device: Sham rTMS; Behavioral: Headache Education Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intensity of Persistent Headaches
Assesses the intensity of persistent headaches, from a scale of 0, being no pain, to 10, being worst possible pain.
Measured: Change from baseline to 2-, 4-, 6-, 8-, 12-, 16-, and 20-weeks follow up visit
Intensity of Debilitating Headaches
Assesses the intensity of debilitating headaches, from a scale of 0, being no pain, to 10, being worst possible pain.
Measured: Change from baseline to 2-, 4-, 6-, 8-, 12-, 16-, and 20-weeks follow up visit
Persistent Headache Frequency
Assesses the frequency per week of persistent headaches
Measured: Change from baseline to 2-, 4-, 6-, 8-, 12-, 16-, and 20-weeks follow up visit
Debilitating Headache Frequency
Assesses the frequency per week of debilitating headaches
Measured: Change from baseline to 2-, 4-, 6-, 8-, 12-, 16-, and 20-weeks follow up visit
Debilitating Headache Interference
Assesses the interference of debilitating headaches for activities of daily living, from 0, being no interference, to 10, being worst possible interference.
Measured: Change from baseline to 2-, 4-, 6-, 8-, 12-, 16-, and 20-weeks follow up visit
Secondary outcomes (6)
Headache Impact Test
Measures the impact of headache on an individual's ability to function at work, school, home, and/or social situations. Each item is measured from never, rarely, sometimes, very often, or always, with scores of 6, 8, 10, 11, and 13 respectively. A higher score correlates to a greater negative impact of headaches on quality of life.
Measured: Change from baseline to 2-, 4-, 6-, 8-, 12-, 16-, and 20-weeks follow up visit
Neurobehavioral Symptom Inventory
Assesses the severity of symptoms in the following areas: somatic, cognitive, affective, and sensory. Each item ranges from 0-4 with a higher score indicating a worse outcome.
Measured: Change from baseline to 2-, 4-, 6-, 8-, 12-, 16-, and 20-weeks follow up visit
Hamilton Rating Scale for Depression
Rates the severity of symptoms observed in depression such as low mood, insomnia, agitation, anxiety and weight loss. Scores range from 0 to 53, with a higher score indicating a larger degree of depression.
Measured: Change from baseline to 2-, 4-, 6-, 8-, 12-, 16-, and 20-weeks follow up visit
Rivermead Post-Concussion Symptoms Questionnaire
Assesses somatic, cognitive, and emotional symptoms experiences after traumatic brain injury. Each item ranges from 0-4, with a higher score indicating a worse outcome.
Measured: Change from baseline to 2-, 4-, 6-, 8-, 12-, 16-, and 20-weeks follow up visit
Short Form Health Survey-36
Measures health status and quality of life in regards to eight main areas: vitality, physical functioning, bodily pain, health perceptions, physical, emotional, and social role functioning and mental health. Each item is scored on a 0 to 100 range, with a higher score indicating a worse outcome.
Measured: Change from baseline to 2-, 4-, 6-, 8-, 12-, 16-, and 20-weeks follow up visit
Short-Form NEURO-QoL
Assesses quality of life related to neurological disorders. Each item ranges from 1-5, with a higher score indicating a worse outcome.
Measured: Change from baseline to 2-, 4-, 6-, 8-, 12-, 16-, and 20-weeks follow up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2022
- Study start1 Jan 2022
- Primary completion31 Aug 2025 (estimated)
- Study completion31 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Randomised
- Intervention model
- Factorial
- Model description
- Each participant will be randomized into one of 4 groups. Blocked randomization will be used with random block size of 4 or 8. Participants will be randomized to study groups in a 1:1:1:1 ratio.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Veterans Medical Research Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Albert Y Leung, MD, Principal investigator, San Diego Veterans Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05176392
- Sponsor's protocol ID
- CP200229
- Other IDs
- W81XWH2110831, H210076
- Status last verified
- Nov 2024
- First submitted
- 24 Nov 2021
- Last updated
- 21 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Nonpharmacological Therapies for MTBI-Related Headaches
- ClinicalTrials.gov ID
- NCT05176392
- Acronym / sponsor ID
- CP200229
- Conditions
- TBI (Traumatic Brain Injury), Headache, Depression
- Keywords
- rTMS, transcranial magnetic stimulation, therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Veterans Medical Research FoundationUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 4 Jan 2022 (actual)
- 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 will assess the combined effectiveness of repetitive transcranial magnetic stimulation (rTMS) and telehealth based therapy in helping manage mild traumatic brain injury (mTBI) related headaches. The investigators hypothesize that active rTMS combined with telehealth therapy will provide marked reduction in mTBI related headaches and symptoms in comparison to their placebo counterparts.
Detailed description
This study will be enrolling a total of 240 veterans or active military over a 4 year period at the VA San Diego Healthcare System (VASDHS). Participants will be randomized into one of four groups:
Group A: active rTMS with telehealth headache management therapy Group B: active rTMS with telehealth headache education control Group C: sham rTMS with telehealth headache management therapy Group D: sham rTMS with telehealth headache education control
Individual participation will consist of 19 visits to the VASDHS and 11 telehealth sessions over the course of 6-7 months. The in person visits will be divided into the following phases:
- PRE-TREATMENT ASSESSMENTS PHASE (weeks 1-2) which consists of Visit 1 (Screening Visit) and Visit 2 (Baseline Assessments with MRI scan);
- INDUCTION TREATMENT PHASE (weeks 3-4) consists of Visits 3-12 (10 weekday neuronavigation guided rTMS sessions at >24 and <72 hours apart); and
- POST-TREATMENT ASSESSMENTS AND MAINTENANCE TREATMENT PHASE (weeks 5-24) consists of 4 initial biweekly post-induction treatment assessments and maintenance treatments (Visits 13-16)) and two additional monthly post-induction assessments and maintenance treatments (Visits 17-18) and one final study visit (Visit 19).
Eight weekly telehealth therapy/education sessions will be conducted from week 3 to 10 with additional three bolster sessions at 4 weeks apart. During the baseline and follow up visits, assessments will be conducted to evaluate headaches, neurobehavioral symptoms, depressive symptoms, post-concussion symptoms, and quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
- Model description
- Each participant will be randomized into one of 4 groups. Blocked randomization will be used with random block size of 4 or 8. Participants will be randomized to study groups in a 1:1:1:1 ratio.
| Arm | Type | Receives |
|---|---|---|
| Active rTMS with telehealth headache management therapy | Active comparator | Device: Active rTMS, Behavioral: Headache Management TherapyParticipants receive both active rTMS treatment at the left dorsolateral prefrontal cortex and therapy for headache management |
| Active rTMS with telehealth headache education control | Other | Device: Active rTMS, Behavioral: Headache Education ControlParticipants receive active rTMS treatment at the left dorsolateral prefrontal cortex and headache education |
| Sham rTMS with telehealth headache management therapy | Other | Behavioral: Headache Management Therapy, Device: Sham rTMSParticipants receive sham rTMS treatment at the left dorsolateral prefrontal cortex and therapy for headache management |
| Sham rTMS with telehealth headache education control | Sham comparator | Device: Sham rTMS, Behavioral: Headache Education ControlParticipants receive sham rTMS treatment at the left dorsolateral prefrontal cortex and headache education |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Mild Traumatic Brain Injury (mTBI)
- Chronic headaches > 3 months after injury
- Aged 18-65
- No prior TMS treatment
- Persistent Headaches with an intensity > 30 / 100
Key exclusion criteria (9 listed)
- Pregnant
- Pacemaker or any metal in body that would prevent MRI
- History of dementia or major psychiatric disease, such as bipolar disorder or schizophrenia
- Presence of any other chronic neuropathic pain states
- History of seizure
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 |
|---|---|---|
| Active rTMSActive rTMS will be given at the left dorsolateral prefrontal cortex with a double blind TMS coil. | Device | Active rTMS with telehealth headache education control, Active rTMS with telehealth headache management therapy |
| Headache Management TherapyTherapy will be provided on headache management. | Behavioural | Active rTMS with telehealth headache management therapy, Sham rTMS with telehealth headache management therapy |
| Sham rTMSSham rTMS will be given at the left dorsolateral prefrontal cortex. All parameters of the treatment will appear identical to the active treatment, with only the rTMS coil used to administer the treatment flipped 180 degrees to prevent stimulation. | Device | Sham rTMS with telehealth headache education control, Sham rTMS with telehealth headache management therapy |
| Headache Education ControlIn the control, educational sessions on headaches will be provided. | Behavioural | Active rTMS with telehealth headache education control, Sham rTMS with telehealth headache education control |
Primary outcome
Intensity of Persistent Headaches
Time frame: Change from baseline to 2-, 4-, 6-, 8-, 12-, 16-, and 20-weeks follow up visit
Assesses the intensity of persistent headaches, from a scale of 0, being no pain, to 10, being worst possible pain.
Intensity of Debilitating Headaches
Time frame: Change from baseline to 2-, 4-, 6-, 8-, 12-, 16-, and 20-weeks follow up visit
Assesses the intensity of debilitating headaches, from a scale of 0, being no pain, to 10, being worst possible pain.
Persistent Headache Frequency
Time frame: Change from baseline to 2-, 4-, 6-, 8-, 12-, 16-, and 20-weeks follow up visit
Assesses the frequency per week of persistent headaches
Debilitating Headache Frequency
Time frame: Change from baseline to 2-, 4-, 6-, 8-, 12-, 16-, and 20-weeks follow up visit
Assesses the frequency per week of debilitating headaches
Debilitating Headache Interference
Time frame: Change from baseline to 2-, 4-, 6-, 8-, 12-, 16-, and 20-weeks follow up visit
Assesses the interference of debilitating headaches for activities of daily living, from 0, being no interference, to 10, being worst possible interference.
6 secondary outcomes
Headache Impact Test
Time frame: Change from baseline to 2-, 4-, 6-, 8-, 12-, 16-, and 20-weeks follow up visit
Neurobehavioral Symptom Inventory
Time frame: Change from baseline to 2-, 4-, 6-, 8-, 12-, 16-, and 20-weeks follow up visit
Hamilton Rating Scale for Depression
Time frame: Change from baseline to 2-, 4-, 6-, 8-, 12-, 16-, and 20-weeks follow up visit
Rivermead Post-Concussion Symptoms Questionnaire
Time frame: Change from baseline to 2-, 4-, 6-, 8-, 12-, 16-, and 20-weeks follow up visit
Short Form Health Survey-36
Time frame: Change from baseline to 2-, 4-, 6-, 8-, 12-, 16-, and 20-weeks follow up visit
Short-Form NEURO-QoL
Time frame: Change from baseline to 2-, 4-, 6-, 8-, 12-, 16-, and 20-weeks follow up visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2024.
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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.
Albert Y Leung, MD principal investigator
San Diego Veterans Healthcare System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active rTMS and Headache Management Therapy in people with TBI (Traumatic Brain Injury) and Headache, run by Veterans Medical Research Foundation 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 6 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 21 Nov 2024. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Caleb Lopez, BS (858-552-8585 ext. 2638, caleb.lopez@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intensity of Persistent Headaches (time frame: Change from baseline to 2-, 4-, 6-, 8-, 12-, 16-, and 20-weeks follow up visit). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Nov 2024.