NCT05381740CompletedEarly phase 1
A Novel Brain Stimulation for Bimanual Motor Function and Control in Chronic Stroke
Source: ClinicalTrials.gov · Last updated 3 Jun 2024
Brief summary (registry, in English)
The long-term goal of this project is to develop and test upper Iimb rehabilitation interventions that can improve bimanual motor function, or the ability to use both arms and hands together, for stroke survivors with moderate to severe impairment. This study will utilize a novel method of non-invasive brain stimulation in conjunction with upper limb training given for 12 visits over a period of 6 weeks. The study will include the following site visits: * Eligibility Screening and Informed Consent Visit * Baseline testing (4 visits total): 1 visit each for MRI, upper limb and bimanual motor function test, bimanual motor control, and neurophysiology related to control of the upper limbs * Repeat baseline testing (4 visits total) of MRI, upper limb and bimanual motor function test, bimanual motor control, and neurophysiology related to control of the upper limbs * 12 intervention visits during which patients will receive upper limb therapy in conjunction with non-invasive brain stimulation * Repeat testing (4 visits total) of MRI, upper limb and bimanual motor function test, bimanual motor control, and neurophysiology related to control of the upper limbs * A follow-up visit 1 month after the completion of interventions
- Status (registry)
- Completed
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 17 (actual)
- First submitted
- 16 May 2022
- Start date
- 8 Mar 2022
- Primary completion date
- 6 Dec 2023
- Lead sponsor
- The Cleveland Clinic
- Diseases
- Stroke
- NCT number
- NCT05381740
What you commit to
- Study type: Interventional · Early phase 1
- Participants enrolled: 17
- From 8 Mar 2022 to the primary completion date, 6 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Occupational therapy or upper limb Botox completed ≤ 2 months prior
Other illness
- Brainstem or cerebellar stroke
- Cognitive impairment (Mini-Mental State Examination \<24)
- Severe impairment of the paretic hand that limits functional task practice (UEFM hand score \< 4 out of 14)
- Contraindications to TMS or MRI (e.g. metal implant in head, seizure history, cardiac pacemaker)
Other
- Bilateral strokes or multiple strokes affecting sensorimotor structures
- Severe spasticity (Modified Ashworth Scale \>3) or upper limb contracture
Who the study is looking for
- Age 18-90 yrs
- ≥6 months since first clinical stroke
- Impairment of the paretic hand, indicated by a score of \<= 11 out of 14 on the hand section of UEFM
- Sufficient range of motion in the wrist and fingers for functional task practice: have at least 10 degrees active wrist extension, 10 degrees active thumb abduction/extension, and 10 degrees active extension in at least 2 additional digits
- Sufficient active shoulder and elbow movement to volitionally position the paretic hand in the workspace for table-top task practice
Age in the registry: 18 years to 90 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Lerner Research Institute; Cleveland Clinic Foundation Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.