Recruitment

Recruitment Status
Completed

Inclusion Criterias

≥ 18 years of age
no other known brain abnormalities by history;
A Chedoke-McMaster Stroke Assessment arm stage and hand stage of 3-6 for the affected limb
...
≥ 18 years of age
no other known brain abnormalities by history;
A Chedoke-McMaster Stroke Assessment arm stage and hand stage of 3-6 for the affected limb
A one-sided stroke resulting in upper extremity paresis
An ischemic or hemorrhagic stroke suffered 3-12 months prior to the study;

Exclusion Criterias

Any condition that would prevent the subject from giving voluntary informed consent;
previous stroke with residual deficits (TIAs not a reason for exclusion);
a concurrent progressive neurologic disorder, acute coronary syndrome, severe heart disease (NYHA Classification > 3), or other major medical condition,
...
Any condition that would prevent the subject from giving voluntary informed consent;
previous stroke with residual deficits (TIAs not a reason for exclusion);
a concurrent progressive neurologic disorder, acute coronary syndrome, severe heart disease (NYHA Classification > 3), or other major medical condition,
Ataxia as measured by a score > 1 on item 7 (limb ataxia) of the NIH stroke scale.
A Mini mental status exam (MMSE) <25.
Pregnant or trying to become pregnant; Lack of pregnancy established in females of child-bearing potential by a negative urine pregnancy test at screening.
patients requiring palliative care
A fixed contraction deformity in the affected limb that would prevent normal dexterity if patient were neurologically intact;
Based on PI's or local physician's assessment patient unable to tolerate the trial procedure due to medical condition
confirmed or suspected lower-limb fracture preventing mobilization,
Any metal in head with the exception of dental work or any ferromagnetic metal elsewhere in the body;
Active alcohol abuse, illicit drug use or drug abuse or significant mental illness
Implanted metallic parts of implanted electronic devices, including pacemakers, defibrillators, or implant medication pump;
A recent injection of phenol to the affected upper limb in the last 6 months, or the need of an injection of phenol anytime during the study period and follow up.
Severe neglect as measured by a score of 2 on item 11 (extinction and inattention) of the NIH stroke scale.
premorbid (retrospective) modified Rankin Scale (mRS) score ≥2 of any aetiology;
patients planning to undergo any other occupational therapy during the 6 week active treatment period of the trial (see section 5.2 for study schedule) than what is provided in the study
Claustrophobia precluding MRI;
Severe sensory deficits as measured by a score of 2 on item 8 of the NIH stroke scale.
Patients unable to comprehend or follow verbal commands
Excessive spasticity as indicated by the Modified Ashworth Spasticity (MAS) Scale >2/4 in either elbow flexors, wrist flexors or finger flexors of the affected limb;i
A recent injection of botulinium toxin to the affected upper limb in the last 3 months, or the need of an injection of botulinum toxin anytime during the study period and follow up.
An implanted brain stimulator;
Patients suffering from depression as measured by a score of >10 on the Patient Health Questionnaire (PHQ9). For clarity, patients diagnosed with depression which is controlled with stable anti-depressive medication and in whom PHQ9 is <10 are eligible to participate in the trial.
History of epilepsy, defined as at least two unprovoked seizures occurring greater than 24 hours apart or diagnosis of an epilepsy syndrome, OR a seizure within the last 12 months.
Severe aphasia as measured by a score of > 2 on item 9 (best language) of the NIH stroke scale.
Enrolled or plans to enroll in an interventional trial during this study;
Scalp wounds or infections;

Summary

Conditions
Stroke
Type
Interventional
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Inclusion Criterias

≥ 18 years of age
no other known brain abnormalities by history;
A Chedoke-McMaster Stroke Assessment arm stage and hand stage of 3-6 for the affected limb
...
≥ 18 years of age
no other known brain abnormalities by history;
A Chedoke-McMaster Stroke Assessment arm stage and hand stage of 3-6 for the affected limb
A one-sided stroke resulting in upper extremity paresis
An ischemic or hemorrhagic stroke suffered 3-12 months prior to the study;

Exclusion Criterias

Any condition that would prevent the subject from giving voluntary informed consent;
previous stroke with residual deficits (TIAs not a reason for exclusion);
a concurrent progressive neurologic disorder, acute coronary syndrome, severe heart disease (NYHA Classification > 3), or other major medical condition,
...
Any condition that would prevent the subject from giving voluntary informed consent;
previous stroke with residual deficits (TIAs not a reason for exclusion);
a concurrent progressive neurologic disorder, acute coronary syndrome, severe heart disease (NYHA Classification > 3), or other major medical condition,
Ataxia as measured by a score > 1 on item 7 (limb ataxia) of the NIH stroke scale.
A Mini mental status exam (MMSE) <25.
Pregnant or trying to become pregnant; Lack of pregnancy established in females of child-bearing potential by a negative urine pregnancy test at screening.
patients requiring palliative care
A fixed contraction deformity in the affected limb that would prevent normal dexterity if patient were neurologically intact;
Based on PI's or local physician's assessment patient unable to tolerate the trial procedure due to medical condition
confirmed or suspected lower-limb fracture preventing mobilization,
Any metal in head with the exception of dental work or any ferromagnetic metal elsewhere in the body;
Active alcohol abuse, illicit drug use or drug abuse or significant mental illness
Implanted metallic parts of implanted electronic devices, including pacemakers, defibrillators, or implant medication pump;
A recent injection of phenol to the affected upper limb in the last 6 months, or the need of an injection of phenol anytime during the study period and follow up.
Severe neglect as measured by a score of 2 on item 11 (extinction and inattention) of the NIH stroke scale.
premorbid (retrospective) modified Rankin Scale (mRS) score ≥2 of any aetiology;
patients planning to undergo any other occupational therapy during the 6 week active treatment period of the trial (see section 5.2 for study schedule) than what is provided in the study
Claustrophobia precluding MRI;
Severe sensory deficits as measured by a score of 2 on item 8 of the NIH stroke scale.
Patients unable to comprehend or follow verbal commands
Excessive spasticity as indicated by the Modified Ashworth Spasticity (MAS) Scale >2/4 in either elbow flexors, wrist flexors or finger flexors of the affected limb;i
A recent injection of botulinium toxin to the affected upper limb in the last 3 months, or the need of an injection of botulinum toxin anytime during the study period and follow up.
An implanted brain stimulator;
Patients suffering from depression as measured by a score of >10 on the Patient Health Questionnaire (PHQ9). For clarity, patients diagnosed with depression which is controlled with stable anti-depressive medication and in whom PHQ9 is <10 are eligible to participate in the trial.
History of epilepsy, defined as at least two unprovoked seizures occurring greater than 24 hours apart or diagnosis of an epilepsy syndrome, OR a seizure within the last 12 months.
Severe aphasia as measured by a score of > 2 on item 9 (best language) of the NIH stroke scale.
Enrolled or plans to enroll in an interventional trial during this study;
Scalp wounds or infections;

Locations

Indianapolis, Indiana, 46202
New York, New York, 10032
Durham, North Carolina, 27705
White Plains, New York, 10605
Downey, California, 90242
...
Indianapolis, Indiana, 46202
New York, New York, 10032
Durham, North Carolina, 27705
White Plains, New York, 10605
Downey, California, 90242
Houston, Texas, 77030
Columbus, Ohio, 43210
Chicago, Illinois, 60611
Boston, Massachusetts, 02129
Cincinnati, Ohio, 45267
Phoenix, Arizona, 85054
Atlanta, Georgia, 30309

Tracking Information

NCT #
NCT02089464
Collaborators
Not Provided
Investigators
  • Principal Investigator: Richard L Harvey, MD Shirley Ryan AbilityLab
  • Richard L Harvey, MD Shirley Ryan AbilityLab