Recruitment

Recruitment Status
Completed

Inclusion Criteria

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

Exclusion Criteria

Scalp wounds or infections;
Active alcohol abuse, illicit drug use or drug abuse or significant mental illness
Severe aphasia as measured by a score of > 2 on item 9 (best language) of the NIH stroke scale.
...
Scalp wounds or infections;
Active alcohol abuse, illicit drug use or drug abuse or significant mental illness
Severe aphasia as measured by a score of > 2 on item 9 (best language) of the NIH stroke scale.
patients requiring palliative care
previous stroke with residual deficits (TIAs not a reason for exclusion);
Any metal in head with the exception of dental work or any ferromagnetic metal elsewhere in the body;
Implanted metallic parts of implanted electronic devices, including pacemakers, defibrillators, or implant medication pump;
Severe neglect as measured by a score of 2 on item 11 (extinction and inattention) of the NIH stroke scale.
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.
confirmed or suspected lower-limb fracture preventing mobilization,
An implanted brain stimulator;
Ataxia as measured by a score > 1 on item 7 (limb ataxia) of the NIH stroke scale.
premorbid (retrospective) modified Rankin Scale (mRS) score ≥2 of any aetiology;
A fixed contraction deformity in the affected limb that would prevent normal dexterity if patient were neurologically intact;
A Mini mental status exam (MMSE) <25.
Severe sensory deficits as measured by a score of 2 on item 8 of the NIH stroke scale.
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.
Any condition that would prevent the subject from giving voluntary informed consent;
Claustrophobia precluding MRI;
Enrolled or plans to enroll in an interventional trial during this study;
Pregnant or trying to become pregnant; Lack of pregnancy established in females of child-bearing potential by a negative urine pregnancy test at screening.
a concurrent progressive neurologic disorder, acute coronary syndrome, severe heart disease (NYHA Classification > 3), or other major medical condition,
Based on PI's or local physician's assessment patient unable to tolerate the trial procedure due to medical condition
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.
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.
Patients unable to comprehend or follow verbal commands
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

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 Criteria

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

Exclusion Criteria

Scalp wounds or infections;
Active alcohol abuse, illicit drug use or drug abuse or significant mental illness
Severe aphasia as measured by a score of > 2 on item 9 (best language) of the NIH stroke scale.
...
Scalp wounds or infections;
Active alcohol abuse, illicit drug use or drug abuse or significant mental illness
Severe aphasia as measured by a score of > 2 on item 9 (best language) of the NIH stroke scale.
patients requiring palliative care
previous stroke with residual deficits (TIAs not a reason for exclusion);
Any metal in head with the exception of dental work or any ferromagnetic metal elsewhere in the body;
Implanted metallic parts of implanted electronic devices, including pacemakers, defibrillators, or implant medication pump;
Severe neglect as measured by a score of 2 on item 11 (extinction and inattention) of the NIH stroke scale.
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.
confirmed or suspected lower-limb fracture preventing mobilization,
An implanted brain stimulator;
Ataxia as measured by a score > 1 on item 7 (limb ataxia) of the NIH stroke scale.
premorbid (retrospective) modified Rankin Scale (mRS) score ≥2 of any aetiology;
A fixed contraction deformity in the affected limb that would prevent normal dexterity if patient were neurologically intact;
A Mini mental status exam (MMSE) <25.
Severe sensory deficits as measured by a score of 2 on item 8 of the NIH stroke scale.
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.
Any condition that would prevent the subject from giving voluntary informed consent;
Claustrophobia precluding MRI;
Enrolled or plans to enroll in an interventional trial during this study;
Pregnant or trying to become pregnant; Lack of pregnancy established in females of child-bearing potential by a negative urine pregnancy test at screening.
a concurrent progressive neurologic disorder, acute coronary syndrome, severe heart disease (NYHA Classification > 3), or other major medical condition,
Based on PI's or local physician's assessment patient unable to tolerate the trial procedure due to medical condition
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.
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.
Patients unable to comprehend or follow verbal commands
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

Locations

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

Tracking Information

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