Recruitment

Recruitment Status
Completed

Inclusion Criteria

no other known brain abnormalities by history;
≥ 18 years of age
A one-sided stroke resulting in upper extremity paresis
...
no other known brain abnormalities by history;
≥ 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;
A Chedoke-McMaster Stroke Assessment arm stage and hand stage of 3-6 for the affected limb

Exclusion Criteria

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

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

no other known brain abnormalities by history;
≥ 18 years of age
A one-sided stroke resulting in upper extremity paresis
...
no other known brain abnormalities by history;
≥ 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;
A Chedoke-McMaster Stroke Assessment arm stage and hand stage of 3-6 for the affected limb

Exclusion Criteria

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

Tracking Information

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