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Combined Transcranial Magnetic Stimulation and Therapy for mTBI Related Headaches

Primary Purpose

TBI (Traumatic Brain Injury), Headache, Depression

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Active rTMS
Headache Management Therapy
Sham rTMS
Headache Education Control
Sponsored by
Veterans Medical Research Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for TBI (Traumatic Brain Injury) focused on measuring rTMS, transcranial magnetic stimulation, therapy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Mild Traumatic Brain Injury (mTBI)
  2. Chronic headaches > 3 months after injury
  3. Aged 18-65
  4. No prior TMS treatment
  5. Persistent Headaches with an intensity > 30 / 100
  6. No history of daily headache prior to mTBI

Exclusion Criteria:

  1. Pregnant
  2. Pacemaker or any metal in body that would prevent MRI
  3. History of dementia or major psychiatric disease, such as bipolar disorder or schizophrenia
  4. Presence of any other chronic neuropathic pain states
  5. History of seizure
  6. Pending litigation
  7. Can't understand English
  8. History of chronic headache like migraine prior to mTBI
  9. Evidence in chart of exacerbation of depressive/anxiety symptoms, active substance dependence, suicidal intent or attempt within previous month

Sites / Locations

  • VA San Diego Healthcare SystemRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Other

Other

Sham Comparator

Arm Label

Active rTMS with telehealth headache management therapy

Active rTMS with telehealth headache education control

Sham rTMS with telehealth headache management therapy

Sham rTMS with telehealth headache education control

Arm Description

Participants receive both active rTMS treatment at the left dorsolateral prefrontal cortex and therapy for headache management

Participants receive active rTMS treatment at the left dorsolateral prefrontal cortex and headache education

Participants receive sham rTMS treatment at the left dorsolateral prefrontal cortex and therapy for headache management

Participants receive sham rTMS treatment at the left dorsolateral prefrontal cortex and headache education

Outcomes

Primary Outcome Measures

Intensity of Persistent Headaches
Assesses the intensity of persistent headaches, from a scale of 0, being no pain, to 10, being worst possible pain.
Intensity of Debilitating Headaches
Assesses the intensity of debilitating headaches, from a scale of 0, being no pain, to 10, being worst possible pain.
Persistent Headache Frequency
Assesses the frequency per week of persistent headaches
Debilitating Headache Frequency
Assesses the frequency per week of debilitating headaches
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.

Full Information

First Posted
November 24, 2021
Last Updated
August 7, 2023
Sponsor
Veterans Medical Research Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT05176392
Brief Title
Combined Transcranial Magnetic Stimulation and Therapy for mTBI Related Headaches
Official Title
Combined Nonpharmacological Therapies for MTBI-Related Headaches
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
August 31, 2025 (Anticipated)
Study Completion Date
August 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Veterans Medical Research Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
TBI (Traumatic Brain Injury), Headache, Depression
Keywords
rTMS, transcranial magnetic stimulation, therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
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
ParticipantCare ProviderInvestigator
Masking Description
The participant, study coordinators and the investigators will be blinded to the rTMS treatment. The participant will be blinded to the therapy group (headache management or headache education).
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active rTMS with telehealth headache management therapy
Arm Type
Active Comparator
Arm Description
Participants receive both active rTMS treatment at the left dorsolateral prefrontal cortex and therapy for headache management
Arm Title
Active rTMS with telehealth headache education control
Arm Type
Other
Arm Description
Participants receive active rTMS treatment at the left dorsolateral prefrontal cortex and headache education
Arm Title
Sham rTMS with telehealth headache management therapy
Arm Type
Other
Arm Description
Participants receive sham rTMS treatment at the left dorsolateral prefrontal cortex and therapy for headache management
Arm Title
Sham rTMS with telehealth headache education control
Arm Type
Sham Comparator
Arm Description
Participants receive sham rTMS treatment at the left dorsolateral prefrontal cortex and headache education
Intervention Type
Device
Intervention Name(s)
Active rTMS
Intervention Description
Active rTMS will be given at the left dorsolateral prefrontal cortex with a double blind TMS coil.
Intervention Type
Behavioral
Intervention Name(s)
Headache Management Therapy
Intervention Description
Therapy will be provided on headache management.
Intervention Type
Device
Intervention Name(s)
Sham rTMS
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Headache Education Control
Intervention Description
In the control, educational sessions on headaches will be provided.
Primary Outcome Measure Information:
Title
Intensity of Persistent Headaches
Description
Assesses the intensity of persistent headaches, from a scale of 0, being no pain, to 10, being worst possible pain.
Time Frame
Change from baseline to 2-, 4-, 6-, 8-, 12-, 16-, and 20-weeks follow up visit
Title
Intensity of Debilitating Headaches
Description
Assesses the intensity of debilitating headaches, from a scale of 0, being no pain, to 10, being worst possible pain.
Time Frame
Change from baseline to 2-, 4-, 6-, 8-, 12-, 16-, and 20-weeks follow up visit
Title
Persistent Headache Frequency
Description
Assesses the frequency per week of persistent headaches
Time Frame
Change from baseline to 2-, 4-, 6-, 8-, 12-, 16-, and 20-weeks follow up visit
Title
Debilitating Headache Frequency
Description
Assesses the frequency per week of debilitating headaches
Time Frame
Change from baseline to 2-, 4-, 6-, 8-, 12-, 16-, and 20-weeks follow up visit
Title
Debilitating Headache Interference
Description
Assesses the interference of debilitating headaches for activities of daily living, from 0, being no interference, to 10, being worst possible interference.
Time Frame
Change from baseline to 2-, 4-, 6-, 8-, 12-, 16-, and 20-weeks follow up visit
Secondary Outcome Measure Information:
Title
Headache Impact Test
Description
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.
Time Frame
Change from baseline to 2-, 4-, 6-, 8-, 12-, 16-, and 20-weeks follow up visit
Title
Neurobehavioral Symptom Inventory
Description
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.
Time Frame
Change from baseline to 2-, 4-, 6-, 8-, 12-, 16-, and 20-weeks follow up visit
Title
Hamilton Rating Scale for Depression
Description
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.
Time Frame
Change from baseline to 2-, 4-, 6-, 8-, 12-, 16-, and 20-weeks follow up visit
Title
Rivermead Post-Concussion Symptoms Questionnaire
Description
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.
Time Frame
Change from baseline to 2-, 4-, 6-, 8-, 12-, 16-, and 20-weeks follow up visit
Title
Short Form Health Survey-36
Description
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.
Time Frame
Change from baseline to 2-, 4-, 6-, 8-, 12-, 16-, and 20-weeks follow up visit
Title
Short-Form NEURO-QoL
Description
Assesses quality of life related to neurological disorders. Each item ranges from 1-5, with a higher score indicating a worse outcome.
Time Frame
Change from baseline to 2-, 4-, 6-, 8-, 12-, 16-, and 20-weeks follow up visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Caleb Lopez, BS
Phone
858-552-8585
Ext
2638
Email
caleb.lopez@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Albert Y Leung, MD
Organizational Affiliation
San Diego Veterans Healthcare System
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA San Diego Healthcare System
City
San Diego
State/Province
California
ZIP/Postal Code
92161
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caleb Lopez, BS
Phone
858-552-8585
Ext
2638
Email
caleb.lopez@va.gov
First Name & Middle Initial & Last Name & Degree
Albert Y Leung, MD

12. IPD Sharing Statement

Learn more about this trial

Combined Transcranial Magnetic Stimulation and Therapy for mTBI Related Headaches

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