Combined Transcranial Magnetic Stimulation and Therapy for mTBI Related Headaches

Depression Clinical Trial

Official title:

Combined Nonpharmacological Therapies for MTBI-Related Headaches

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05176392
• Other study ID #: CP200229
• Secondary ID: W81XWH2110831H21
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: August 31, 2025

Study information

• Verified date: November 2023
• Source: Veterans Medical Research Foundation
• Contact: Caleb Lopez, BS
• Phone: 858-552-8585
• Email: caleb.lopez[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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: 1. PRE-TREATMENT ASSESSMENTS PHASE (weeks 1-2) which consists of Visit 1 (Screening Visit) and Visit 2 (Baseline Assessments with MRI scan); 2. INDUCTION TREATMENT PHASE (weeks 3-4) consists of Visits 3-12 (10 weekday neuronavigation guided rTMS sessions at >24 and <72 hours apart); and 3. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: August 31, 2025
• Est. primary completion date: August 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Depression
• Headache
• TBI (Traumatic Brain Injury)

Intervention

Device:
• Active rTMS
Active rTMS will be given at the left dorsolateral prefrontal cortex with a double blind TMS coil.

Behavioral:
• Headache Management Therapy
Therapy will be provided on headache management.

Device:
• Sham rTMS
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.

Behavioral:
• Headache Education Control
In the control, educational sessions on headaches will be provided.

Locations

Country	Name	City	State
United States	VA San Diego Healthcare System	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Veterans Medical Research Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intensity of Persistent Headaches	Assesses the intensity of persistent headaches, from a scale of 0, being no pain, to 10, being worst possible pain.	Change from baseline to 2-, 4-, 6-, 8-, 12-, 16-, and 20-weeks follow up visit
Primary	Intensity of Debilitating Headaches	Assesses the intensity of debilitating headaches, from a scale of 0, being no pain, to 10, being worst possible pain.	Change from baseline to 2-, 4-, 6-, 8-, 12-, 16-, and 20-weeks follow up visit
Primary	Persistent Headache Frequency	Assesses the frequency per week of persistent headaches	Change from baseline to 2-, 4-, 6-, 8-, 12-, 16-, and 20-weeks follow up visit
Primary	Debilitating Headache Frequency	Assesses the frequency per week of debilitating headaches	Change from baseline to 2-, 4-, 6-, 8-, 12-, 16-, and 20-weeks follow up visit
Primary	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.	Change from baseline to 2-, 4-, 6-, 8-, 12-, 16-, and 20-weeks follow up visit
Secondary	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.	Change from baseline to 2-, 4-, 6-, 8-, 12-, 16-, and 20-weeks follow up visit
Secondary	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.	Change from baseline to 2-, 4-, 6-, 8-, 12-, 16-, and 20-weeks follow up visit
Secondary	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.	Change from baseline to 2-, 4-, 6-, 8-, 12-, 16-, and 20-weeks follow up visit
Secondary	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.	Change from baseline to 2-, 4-, 6-, 8-, 12-, 16-, and 20-weeks follow up visit
Secondary	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.	Change from baseline to 2-, 4-, 6-, 8-, 12-, 16-, and 20-weeks follow up visit
Secondary	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.	Change from baseline to 2-, 4-, 6-, 8-, 12-, 16-, and 20-weeks follow up visit