Theta Burst Stimulation for Headaches After Traumatic Brain Injury

NCT04906603 | Unknown FDA Device

• 1 other identifier: VAM-19-00458
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate if theta burst stimulation (TBS) can reduce chronic headaches caused by a traumatic brain injury (TBI). TBS is a safe, drug-free brain stimulation technique that uses magnets to create electricity and stimulate nerve cells in the brain. After repeated TBS sessions, the increased stimulation of nerve cells can alter the way the brain communicates with itself (by creating new neural pathways) which, in turn, can reduce pain symptoms. Participants in this study will complete a baseline assessment followed by four weeks of daily home headache assessment. Participants will then receive four weeks of TBS administered three times per day and three days per week. After TBS is completed, participants will complete an additional four weeks of daily home headache assessment and return for a one-month follow-up assessment. Participation is expected to last three months.

Conditions

Post-Traumatic Headache; Transcranial Magnetic Stimulation; Brain Injuries, Traumatic; Quality of Life

Outcome Measures

Primary Outcomes (4)

• Ecological Momentary Assessment (EMA) for Headache Frequency, Intensity, and Impairment

  EMA will be used for repeated real-time sampling of headaches symptoms prior to intervention, during intervention, and after intervention. Participants will access the EMA application (app) on their personal smartphones.

  Participants will take the daily headache assessment every day for 2 weeks pre-intervention, every day for 4 weeks during intervention, and every day for 4 weeks post-intervention to track their change in headache frequency, intensity, and impairment.

• World Health Organization Quality of Life Scale (WHOQOL-BREF)

  The WHOQOL-BREF is a 26-item self-report assessment of quality of life and will be used to assess changes in QOL over the course of the study. Items are rated on a scale from 1 (very poor) to 5 (very good).

  Baseline visit, pre-intervention (2 weeks after baseline), post-intervention (4 weeks after pre-intervention), and at follow-up (1 month post-intervention).

• Migraine Disability Assessment (MIDAS)

  The MIDAS is a 5-item self-report assessment of headache disability and will be used to assess change in headache impairment over the course of the study. Participants are to respond with the number of days they have experienced various types of headache disability. The last question asks them to rate on a scale from 0 (no pain at all) to 10 (pain as bad as it can be).

  Baseline visit, pre-intervention (2 weeks after baseline), post-intervention (4 weeks after pre-intervention), and at follow-up (1 month post-intervention).

• Patient-Reported Outcomes Measurement Information System - Pain Interference - Short Form 6b (PROMIS-SF6b)

  The PROMIS-SF6b is a 6-item self-report assessment of pain interference and will be used to assess change in universal (non-headache specific) pain over the course of the study. Items are rated on a 5 point scale from "Not at all" to "Very Much".

  Baseline visit, pre-intervention (2 weeks after baseline), post-intervention (4 weeks after pre-intervention), and at follow-up (1 month post-intervention).

Secondary Outcomes (8)

• Barratt Impulsiveness Scale - Version 11 (BIS-11)

  Baseline visit, pre-intervention (2 weeks after baseline), post-intervention (4 weeks after pre-intervention), and at follow-up (1 month post-intervention).

• Beck Anxiety Inventory (BAI)

  Baseline visit, pre-intervention (2 weeks after baseline), post-intervention (4 weeks after pre-intervention), and at follow-up (1 month post-intervention).

• Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR)

  Baseline visit, pre-intervention (2 weeks after baseline), post-intervention (4 weeks after pre-intervention), and at follow-up (1 month post-intervention).

• PTSD Checklist for DSM-V (PCL-5)

  Baseline visit, pre-intervention (2 weeks after baseline), post-intervention (4 weeks after pre-intervention), and at follow-up (1 month post-intervention).

• Dot Counting (Cognitive Task)

  The dot counting task will be administered at every stimulation visit during the 4 weeks of intervention (total of 12 times).

Study Arms (1)

TBS Headache

EXPERIMENTAL

Device: Theta Burst Stimulation

Interventions

Theta Burst Stimulation DEVICE

TBS will be administered three times per day and three days per week for four weeks (totaling 12 TBS intervention visits and 36 TBS intervention sessions). Each TBS intervention session will last approximately 10 minutes (stimulation parameters = 50 Hz, 3 pulses, 10 bursts, 10 second cycle time, 60 cycles, 1800 total pulses).

TBS Headache

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Veterans receiving services through the MVAHCS
• History of mild TBI according to VA/DoD Clinical Practice Guidelines (2009) with one or more of the following criteria present after head injury:
• Loss of consciousness between 0-30 minutes
• Post-traumatic amnesia between 0-24 hours
• Alteration of consciousness/mental state up to 24 hours
• Glasgow Coma Score between 13-15 (best available score within first 24 hours)
• Post-traumatic headaches defined by International Classification for Headache Diagnosis 3rd Edition (ICHD-3) guidelines with the following criteria present:
• Headaches developing within seven days following trauma or injury to the head and/or neck
• Headaches persisting beyond three months
• Chronic daily headaches defined by clinical standards with the following criterion present:
• o 15 or more headache days per month
• Men and women 18-75 years of age
• Possess a smartphone and agree to download and use the EMA application on their personal device
• Capable and willing to provide voluntary informed consent

You may not qualify if:

• History of moderate or severe TBI according to VA/DoD Clinical Practice Guidelines (2009) with one or more of the following criteria present after head injury:
• Loss of consciousness greater than 30 minutes
• Post-traumatic amnesia greater than 24 hours
• Worst Glasgow Coma Scale less than 13 within the first 24 hours unless invalidated upon review (e.g., attributable to intoxication, sedation, systemic shock)
• Abnormal structural imaging
• Current (within six months of enrollment) psychosis and mania
• Personal history of epilepsy or seizure disorder
• o Does not include seizures therapeutically-induced by ECT or identified as a single seizure event (based on the principal investigator's judgement)
• Metal particles in the eye or head (exclusive of the mouth) (e.g., shrapnel, fragments from welding or metalwork, etc.)
• Implanted medical device above the clavicle (e.g., aneurysm clips, shunts, stimulators, cochlear implants, electrodes, etc.)
• Significant neurological disorder or insult that would impact risk (based on the principal investigator's judgement and research literature)
• Current use of medications with significant potential for lowering seizure threshold
• Current benzodiazepine usage at a dose higher than 3mg of lorazepam or equivalent
• Electroconvulsive therapy (ECT) or cortical energy exposure within one month of enrollment (including participation in any other neuromodulation treatments or studies)
• Current (within one month of enrollment) participation in another interventional study that would impact the results of this research

Sponsors & Collaborators

• Minneapolis Veterans Affairs Medical Center: lead
• Minnesota Office of Higher Education: collaborator
• The Defense and Veterans Brain Injury Center: collaborator

Study Sites (1)

Minneapolis VA Health Care System

Minneapolis, Minnesota, 55417, United States

RECRUITING

MeSH Terms

Conditions

Post-Traumatic Headache; Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Headache Disorders, Secondary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Injuries; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Central Study Contacts

Katrina Friedrich

CONTACT

612-467-1811; katrina.friedrich@va.gov

Alyssa Krueger

CONTACT

612-467-1829; Alyssa.Krueger@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Model Details: Open-label pilot study

Study Record Dates

• First Submitted: May 4, 2021
• First Posted: May 28, 2021
• Study Start: November 1, 2019
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2023
• Last Updated: May 28, 2021

Record last verified: 2021-05

Locations

US (1)