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New treatment option for Stroke
Official title Cortical Priming to Optimize Gait Rehabilitation in Stroke: a Renewal
ClinicalTrials.gov ID: NCT04477330
What this study is testing
- What it's testing
- Achieving functional ambulation post stroke continues to be a challenge for stroke survivors, clinicians, and researchers. In the effort to enhance outcomes of motor training, cortical priming using brain stimulation has emerged as a promising adjuvant to conventional rehabilitation.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age greater than 18 years
- First ever monohemispheric stroke \> 3 months since onset
- Residual hemiparetic gait deficits (e.g. abnormal gait pattern)
- Able to walk for 5 minutes at self-paced speed. Handheld assistive device is acceptable.
- Walking speed lesser than 1.2 m/s
You likely can't join if
- General exclusion criteria
- Severe osteoporosis
- Contracture-limiting range of motion of lower limb
- Score of more than 2 on the Modified Ashworth Scale (indicating increased muscle tone through ankle range of motion)
- Uncontrolled anti-spasticity medications during the study period
- Score less than 6 on the Fugl-Meyer Sensory Assessment Scale for the Lower Limb
See the full eligibility criteria
- Age greater than 18 years
- First ever monohemispheric stroke \> 3 months since onset
- Residual hemiparetic gait deficits (e.g. abnormal gait pattern)
- Able to walk for 5 minutes at self-paced speed. Handheld assistive device is acceptable.
- Walking speed lesser than 1.2 m/s
- Lower limb Fugl-Meyer Motor score between 15-30
- At least 5 deg of ankle dorsiflexion necessary to perform the ankle-tracking task
- General exclusion criteria
- Severe osteoporosis
- Contracture-limiting range of motion of lower limb
- Score of more than 2 on the Modified Ashworth Scale (indicating increased muscle tone through ankle range of motion)
- Uncontrolled anti-spasticity medications during the study period
- Score less than 6 on the Fugl-Meyer Sensory Assessment Scale for the Lower Limb
- Cardiorespiratory or metabolic diseases (e.g. cardiac arrhythmia, uncontrolled hypertension or diabetes, chronic emphysema)
- Unhealed decubiti, persistent infection
- Significant cognitive or communication impairment (Mini-Mental State Examination (MMSE)\<21), which could impede the understanding of the purpose of procedures of the study or prevent the patient from performing the...
- Lesions involving the brainstem and cerebellum
- Failure to pass the graded exercise stress test TMS exclusion criteria
- Implanted cardiac pacemaker
- Metal implants in the head or face
- Unexplained, recurring headaches
- History of seizures or epilepsy
- Currently under medication that could increase motor excitability and lower seizure threshold
- Skull abnormalities or fractures
- Concussion within the last 6 months
- Currently pregnant tDCS exclusion criteria
- Skin hypersensitivity
- History of contact dermatitits
- History of allodynia and/or hyperalgesia
- Any other skin or scalp condition that could be aggravated by tDCS
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chicago, Illinois, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.