A study to find out the safety and efficacy of a medical device called â??BQ 1.0â?? in the treatment of patients suffering from stroke.
- Conditions
- Health Condition 1: I678- Other specified cerebrovascular diseases
- Registration Number
- CTRI/2018/08/015518
- Lead Sponsor
- BrainQ Technologies
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1. Diagnosis of 1st ever ischemic stroke confirmed by imaging
2. 72h to 15 days from stroke onset.
3. Medically stable patients
4. Age: greater than 18, less than 80 years, and independent in their daily activities before the stroke
5. Right dominant hand
6. FM greater than 10, less than 35 of upper tested limb.
7. Able to sit in a chair for 70 consecutive minutes and follow three verbal instructions:
- Bring your healthy arm to the level of your shoulder
- Pick up this pen with your healthy hand.
- Put your healthy hand on your waist
8. Able to understand the information provided and provide informed consent
1. Previous stroke
2. Contraindication for performing MRI scanning
3. History of recent epileptic seizures or epilepsy and/or currently taking medication that are known to lower the seizure threshold
4. Patients with an acute problem such as active infection at the time of recruitment for research
5. Previous disease of the central nervous system
6. Damage to the joints, bones and muscles causing restriction of movement of the upper limb being tested
7. Patients known to suffer from some peripheral nerve damage of the upper limb that being tested
8. Pregnant women and women who have the ability to become pregnant unless they are on an acceptable method of contraception during the study.
9. Alcoholism or drug addiction as defined by DSM-IV within last 5 years.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method