Ignite Creation Date:
2025-12-24 @ 7:12 PM
Ignite Modification Date:
2026-01-01 @ 10:44 AM
Study NCT ID:
NCT04906603
Status:
UNKNOWN
Last Update Posted:
2021-05-28
First Post:
2021-05-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Theta Burst Stimulation for Headaches After Traumatic Brain Injury
Sponsor:
Minneapolis Veterans Affairs Medical Center
Organization:
Study Overview
Official Title:
Theta Burst Stimulation for Headaches After Traumatic Brain Injury
Status:
UNKNOWN
Status Verified Date:
2021-05
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Detailed Description:
The primary objective of this study is to investigate the safety and efficacy of theta burst stimulation (TBS) for the management of post-traumatic headaches to improve outcomes and quality of life for individuals who have suffered a traumatic brain injury (TBI). To improve tolerability and logistical burden, we have developed a novel design whereby participants will receive three doses of TBS on alternate days of the week. This design will allow us to assess efficacy while leveraging an accelerated treatment course (nine stimulation sessions per week). We have three specific aims:
Specific Aim 1. To determine the efficacy and safety of TBS for the treatment of post-traumatic headache among individuals who have sustained a mild TBI. Hypothesis 1a: TBS will be safe, well-tolerated, and reduce the number of headache days. Hypothesis 1b: TBS will improve function and quality of life outcomes.
Specific Aim 2: To determine the efficacy and safety of an accelerated time-course of TBS for the management of post-traumatic headache. Hypothesis 2a: The accelerated-time course will be safe, well-tolerated, and improve quality of life outcomes. Hypothesis 2b: The accelerated time-course will produce greater and faster improvement in headache symptoms than that reported in the literature for standard repetitive transcranial magnetic stimulation (rTMS) protocols.
Specific Aim 3: To examine the durability of treatment response to accelerated TBS during a one-month observational period. Hypothesis 3: Accelerated TBS will result in enduring treatment response of post-traumatic headache symptoms over the follow-up period.
This study will be an open-label pilot study and will enroll 20. Participants will complete four weeks of pre-intervention headache assessment via Ecological Momentary Assessment (EMA). Participants will then receive TBS intervention three times a week for four weeks. TBS will be administered in 10-minute sessions, three times per day with 20 minutes between sessions. TBS intervention will be completed using the Magstim Horizon Performance Transcranial Magnetic Stimulation (Magstim Company, Ltd.) device or the MagVenture MagPro X100 with MagOption Transcranial Magnetic Stimulation device (MagVenture, Inc.). Both devices are FDA-cleared to provide TBS for the treatment of Major Depressive Disorder and will be used off-label for this study. After TBS intervention, participants will complete an additional four weeks of EMA headache assessment and return for a one-month follow-up assessment. Participants will be assessed with multiple instruments and at multiple timepoints including interviews, questionnaires, and cognitive functioning assessments.
Specific Aim 1. To determine the efficacy and safety of TBS for the treatment of post-traumatic headache among individuals who have sustained a mild TBI. Hypothesis 1a: TBS will be safe, well-tolerated, and reduce the number of headache days. Hypothesis 1b: TBS will improve function and quality of life outcomes.
Specific Aim 2: To determine the efficacy and safety of an accelerated time-course of TBS for the management of post-traumatic headache. Hypothesis 2a: The accelerated-time course will be safe, well-tolerated, and improve quality of life outcomes. Hypothesis 2b: The accelerated time-course will produce greater and faster improvement in headache symptoms than that reported in the literature for standard repetitive transcranial magnetic stimulation (rTMS) protocols.
Specific Aim 3: To examine the durability of treatment response to accelerated TBS during a one-month observational period. Hypothesis 3: Accelerated TBS will result in enduring treatment response of post-traumatic headache symptoms over the follow-up period.
This study will be an open-label pilot study and will enroll 20. Participants will complete four weeks of pre-intervention headache assessment via Ecological Momentary Assessment (EMA). Participants will then receive TBS intervention three times a week for four weeks. TBS will be administered in 10-minute sessions, three times per day with 20 minutes between sessions. TBS intervention will be completed using the Magstim Horizon Performance Transcranial Magnetic Stimulation (Magstim Company, Ltd.) device or the MagVenture MagPro X100 with MagOption Transcranial Magnetic Stimulation device (MagVenture, Inc.). Both devices are FDA-cleared to provide TBS for the treatment of Major Depressive Disorder and will be used off-label for this study. After TBS intervention, participants will complete an additional four weeks of EMA headache assessment and return for a one-month follow-up assessment. Participants will be assessed with multiple instruments and at multiple timepoints including interviews, questionnaires, and cognitive functioning assessments.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: