Chronic Post-stroke Headache
Conditions
Keywords
Vascular Headaches, post-stroke headache
Brief summary
There are over 7 million people living with stroke in the United States. Per year, approximately 17,000 Veterans are admitted to the VA for acute stroke. Chronic pain after stroke can occur between 10-50% of stroke survivors. Post-stroke pain (PSP) can lead to further complications in a stroke survivor's recovery. Exercise has improved PSP and associated symptoms such as mobility, fatigue, and quality of life. Repetitive transcranial magnetic stimulation (rTMS) is a noninvasive technique using electromagnetic induction for cortical neurostimulation. The use of rTMS has been explored shown to be effective in treating chronic PSP but is limited in effect duration. Our proposal will test the hypothesis that rTMS is feasible and safe to be paired with exercise. Additionally, the investigators believe a complementary effect can develop to enhance the neurostimulation duration of rTMS.
Interventions
DEVICEActive rTMS and exercise
active
COMBINATION_PRODUCTSham rTMS+Exercise
sham
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Double-blind
Intervention model description
Feasibility of a double-blind sham-controlled intervention
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female Veteran of US military 19 years of age * Signed informed consent * Minimum of 3-months since time of stroke and medically stable * Headache has persisted for \>3 months after stabilization of the stroke * Ability to walk or tolerate recumbent cycle ergometry for 10 mins without assistance * Stable pain medication regimen for 1 month prior to study * Females of child-bearing potential (i.e. not postmenopausal or surgically sterile) must be using a medically acceptable method of birth control and should not be pregnant nor have plans for pregnancy or breastfeeding during the study * Completed diagnostic, maximal graded exercise test including 12-lead ECG and indirect calorimetry (i.e. oxygen uptake, minute ventilation, respiratory exchange ratio, etc.) * Minimum pain intensity of 30 on the Mechanical Visual Analogue Scale on average with pain symptoms.
Exclusion criteria
* Moderate to severe cognitive impairment (Montreal Cognitive Assessment score \<16/30) * Pre-stroke modified Rankin \>2 * History of seizures * Presence of any standard TMS or MRI contraindications (see human subjects) * Current diagnosis of DSM-5-defined bipolar disorder I, schizophrenia, schizoaffective disorder, or obsessive-compulsive disorder * Diagnosis of moderate or severe substance use disorder (except for caffeine and nicotine) during the preceding 3 months (Participants must agree to abstain from illicit drugs during the study) * Increased risk of suicide that necessitates inpatient treatment or warrants additional therapy excluded by the protocol; and/or intensity of suicidal ideation (Type 4 or Type 5) or any suicidal behavior in the past 3 months on Columbia Suicide Severity Rating Scale (C-SSRS) * Litigating for compensation for a psychiatric disorder * Veterans who are in the process of applying for or receiving VA service-connected disability are eligible * Current enrollment in another intervention trial for pain or stroke * Persons imprisoned, of minor age, diagnosed with terminal illness, or require surrogate for consent * Fails baseline exercise screening activities * Persistent post-stroke headaches not better accounted for by another diagnosis * Is unable to reliably attend intervention sessions i.e. planning to move, transportation issues * Neurological disorder pre- or post- stroke affecting subject's ability to follow study directions
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Modified Rankin Scale From Baseline to Follow-up 30 Days After Last Intervention | From baseline to follow-up 30 days after last intervention | The modified Ranking scale (mRS) is a single-item, global, Likert-type scale ranging from 0-6 (higher scores mean a worse outcome) to categorize level of functional independence with comparison to pre-stroke function, accounting for activities of daily living. Participants were scored at baseline and 30 days after last intervention. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Active rTMS+Exercise active rTMS
Active rTMS and exercise: active | 5 |
| Sham rTMS+Exercise sham rTMS
Sham rTMS+Exercise: sham | 4 |
| Total | 9 |
Baseline characteristics
| Characteristic | Active rTMS+Exercise | Total | Sham rTMS+Exercise |
|---|---|---|---|
| Age, Continuous | 63.7 years STANDARD_DEVIATION 8.9 | 62 years STANDARD_DEVIATION 8 | 59.9 years STANDARD_DEVIATION 7.6 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 3 Participants | 4 Participants | 1 Participants |
| Region of Enrollment United States | 5 Participants | 9 Participants | 4 Participants |
| Sex: Female, Male Female | 0 Participants | 2 Participants | 2 Participants |
| Sex: Female, Male Male | 5 Participants | 7 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 0 / 4 |
| other Total, other adverse events | 0 / 5 | 0 / 4 |
| serious Total, serious adverse events | 0 / 5 | 0 / 4 |
Outcome results
Primary
Change in Modified Rankin Scale From Baseline to Follow-up 30 Days After Last Intervention
The modified Ranking scale (mRS) is a single-item, global, Likert-type scale ranging from 0-6 (higher scores mean a worse outcome) to categorize level of functional independence with comparison to pre-stroke function, accounting for activities of daily living. Participants were scored at baseline and 30 days after last intervention.
Time frame: From baseline to follow-up 30 days after last intervention
Population: Only participants completing both the baseline and followup mRS assessment were included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active rTMS+Exercise | Change in Modified Rankin Scale From Baseline to Follow-up 30 Days After Last Intervention | 0 units on a scale | Standard Deviation 0 |
| Sham rTMS+Exercise | Change in Modified Rankin Scale From Baseline to Follow-up 30 Days After Last Intervention | 1 units on a scale | Standard Deviation 1.41 |
p-value: 0.896Wilcoxon (Mann-Whitney)