Stroke study: Tele-CE
Official title Tele-CE in Severe Stroke
ClinicalTrials.gov ID: NCT07652970
What this study is testing
- What it's testing
- The study wants to see if training the unaffected leg at home can change brain activity and improve leg function after a severe stroke, and whether people find it doable and acceptable.
- Who it's for
- Adults who have had a severe stroke and can use a computer or phone for remote sessions.
- What's involved
- Participants will do ten remote training sessions, either moving and strengthening the healthy leg or doing cognitive tasks with the healthy leg, while researchers measure brain and spinal activity and leg function before and after each type of training. They will also complete a feedback questionnaire.
- Time commitment
- The study lasts about a few weeks, with ten remote training sessions and pre‑ and post‑testing for each session type.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Single, monohemispheric stroke
- Chronic stroke (\> 6 months prior)
- Severe stroke (Fugl-Meyer Lower Extremity motor scale score \< 21 or 6 Minute Walk Test distance \< 300m)
You likely can't join if
- Use of anti-spasticity medications
- Existence of other neurological disorders
- Have brainstem or cerebellar lesions.
- Mini-Mental State Examiniation score of \<21, to ensure participants have the cognitive capacity to consent and can understand instructions both...
- Non-English-speaking individuals
- Bone, joint or soft tissue injury
See the full eligibility criteria
- Single, monohemispheric stroke
- Chronic stroke (\> 6 months prior)
- Severe stroke (Fugl-Meyer Lower Extremity motor scale score \< 21 or 6 Minute Walk Test distance \< 300m)
- Use of anti-spasticity medications
- Existence of other neurological disorders
- Have brainstem or cerebellar lesions.
- Mini-Mental State Examiniation score of \<21, to ensure participants have the cognitive capacity to consent and can understand instructions both in-person and during remote supervision.
- Non-English-speaking individuals
- Bone, joint or soft tissue injury
- Uncontrolled medical conditions (such as uncontrolled hypertension, untreated cardiac disease, or untreated pulmonary disease)
- Unable to see the tablet and zoom screen
- Unable to move non-paretic ankle (\< 5 degrees of ankle ROM)
- Fugl-Meyer Lower Extremity sensory scale score \< 6 TMS exclusion criteria
- Previous adverse reaction to TMS
- Skull abnormalities or fractures
- Concussion within the prior 6 months
- Unexplained, recurring headaches
- Implanted cardiac pacemaker
- Metal implants in the head or face
- History of seizures or epilepsy
- Use of medications that could alter cortical excitability or increase risk of seizure (e.g., antidepressants, antipsychotics, anxiolytics, anticonvulsants)
- Current pregnancy PNS exclusion criteria
- Skin hypersensitivity at any sites of stimulation, including the scalp, thoracolumbar spine, and peripheral limbs
- History of contact dermatitis at any of the sites of stimulation
- History of allodynia and/or hyperalgesia
- Active skin infection
- Skin lesions
- Deep vein thrombosis
- Any other skin or scalp condition that could be aggravated by stimulation
- Implanted electronic, metallic, or highly conductive devices near site of stimulation that cannot be removed without permission from a health professional
The study team makes the final eligibility decision.
Where it is enrolling
- 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, but 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 to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Chicago, Illinois, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.