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TMS and Exercise for Post-stroke Pain

Primary Purpose

Chronic Post-stroke Headache

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Active rTMS and exercise
Sham rTMS+Exercise
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Post-stroke Headache focused on measuring Vascular Headaches, post-stroke headache

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Birmingham VA Medical Center, Birmingham, ALRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

active rTMS+Exercise

sham rTMS+Exercise

Arm Description

active rTMS

sham rTMS

Outcomes

Primary Outcome Measures

Visual Analogue Scale for Pain
The visual analog scale (VAS) is a validated, subjective measure for pain. Scores are based on self-reported measures of symptoms that are recorded with a single handwritten mark placed at one point along the length of a 10-cm line that represents a continuum between the two ends of the scale-"no pain" on the left end (0 cm) of the scale and the "worst pain" on the right end of the scale (10 cm)

Secondary Outcome Measures

Full Information

First Posted
December 11, 2020
Last Updated
December 21, 2022
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT04672044
Brief Title
TMS and Exercise for Post-stroke Pain
Official Title
Feasibility of Combination Exercise and Neuromodulation Rehabilitation to Improve Post-stroke Chronic Pain
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 14, 2022 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Post-stroke Headache
Keywords
Vascular Headaches, post-stroke headache

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
Feasibility of a double-blind sham-controlled intervention
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Double-blind
Allocation
Randomized
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
active rTMS+Exercise
Arm Type
Active Comparator
Arm Description
active rTMS
Arm Title
sham rTMS+Exercise
Arm Type
Sham Comparator
Arm Description
sham rTMS
Intervention Type
Device
Intervention Name(s)
Active rTMS and exercise
Intervention Description
active
Intervention Type
Combination Product
Intervention Name(s)
Sham rTMS+Exercise
Intervention Description
sham
Primary Outcome Measure Information:
Title
Visual Analogue Scale for Pain
Description
The visual analog scale (VAS) is a validated, subjective measure for pain. Scores are based on self-reported measures of symptoms that are recorded with a single handwritten mark placed at one point along the length of a 10-cm line that represents a continuum between the two ends of the scale-"no pain" on the left end (0 cm) of the scale and the "worst pain" on the right end of the scale (10 cm)
Time Frame
through study completion, an average of 12 weeks
Other Pre-specified Outcome Measures:
Title
modified Rankin Scale
Description
Measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. Score Description: 0 No symptoms at all No significant disability despite symptoms; able to carry out all usual duties and activities Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance Moderate disability; requiring some help, but able to walk without assistance Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance Severe disability; bedridden, incontinent and requiring constant nursing care and attention Dead
Time Frame
through study completion, an average of 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chen Lin, MD
Phone
(205) 933-8101
Email
Chen.Lin@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chen Lin, MD
Organizational Affiliation
Birmingham VA Medical Center, Birmingham, AL
Official's Role
Principal Investigator
Facility Information:
Facility Name
Birmingham VA Medical Center, Birmingham, AL
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chen Lin, MD
Phone
205-933-8101
Email
Chen.Lin@va.gov
First Name & Middle Initial & Last Name & Degree
Chen Lin, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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TMS and Exercise for Post-stroke Pain

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