Niche Trial: Navigated Inhibitory rTMS to Contralesional Hemisphere Trial
Last updated on April 2022Recruitment
- Recruitment Status
- Completed
Inclusion Criteria
- 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
- ≥ 18 years of age
- no other known brain abnormalities by history;
- A one-sided stroke resulting in upper extremity paresis
- An ischemic or hemorrhagic stroke suffered 3-12 months prior to the study;
Exclusion Criteria
- Implanted metallic parts of implanted electronic devices, including pacemakers, defibrillators, or implant medication pump;
- 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
- Any condition that would prevent the subject from giving voluntary informed consent;
- ...
- Implanted metallic parts of implanted electronic devices, including pacemakers, defibrillators, or implant medication pump;
- 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
- Any condition that would prevent the subject from giving voluntary informed consent;
- Any metal in head with the exception of dental work or any ferromagnetic metal elsewhere in the body;
- Severe neglect as measured by a score of 2 on item 11 (extinction and inattention) of the NIH stroke scale.
- 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.
- Claustrophobia precluding MRI;
- 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.
- An implanted brain stimulator;
- Active alcohol abuse, illicit drug use or drug abuse or significant mental illness
- confirmed or suspected lower-limb fracture preventing mobilization,
- Severe aphasia as measured by a score of > 2 on item 9 (best language) of the NIH stroke scale.
- A fixed contraction deformity in the affected limb that would prevent normal dexterity if patient were neurologically intact;
- Enrolled or plans to enroll in an interventional trial during this study;
- 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
- Based on PI's or local physician's assessment patient unable to tolerate the trial procedure due to medical condition
- previous stroke with residual deficits (TIAs not a reason for exclusion);
- Scalp wounds or infections;
- 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.
- 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.
- 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.
- Pregnant or trying to become pregnant; Lack of pregnancy established in females of child-bearing potential by a negative urine pregnancy test at screening.
- 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.
- patients requiring palliative care
- Patients unable to comprehend or follow verbal commands
- premorbid (retrospective) modified Rankin Scale (mRS) score ≥2 of any aetiology;
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
- 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
- ≥ 18 years of age
- no other known brain abnormalities by history;
- A one-sided stroke resulting in upper extremity paresis
- An ischemic or hemorrhagic stroke suffered 3-12 months prior to the study;
Exclusion Criteria
- Implanted metallic parts of implanted electronic devices, including pacemakers, defibrillators, or implant medication pump;
- 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
- Any condition that would prevent the subject from giving voluntary informed consent;
- ...
- Implanted metallic parts of implanted electronic devices, including pacemakers, defibrillators, or implant medication pump;
- 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
- Any condition that would prevent the subject from giving voluntary informed consent;
- Any metal in head with the exception of dental work or any ferromagnetic metal elsewhere in the body;
- Severe neglect as measured by a score of 2 on item 11 (extinction and inattention) of the NIH stroke scale.
- 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.
- Claustrophobia precluding MRI;
- 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.
- An implanted brain stimulator;
- Active alcohol abuse, illicit drug use or drug abuse or significant mental illness
- confirmed or suspected lower-limb fracture preventing mobilization,
- Severe aphasia as measured by a score of > 2 on item 9 (best language) of the NIH stroke scale.
- A fixed contraction deformity in the affected limb that would prevent normal dexterity if patient were neurologically intact;
- Enrolled or plans to enroll in an interventional trial during this study;
- 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
- Based on PI's or local physician's assessment patient unable to tolerate the trial procedure due to medical condition
- previous stroke with residual deficits (TIAs not a reason for exclusion);
- Scalp wounds or infections;
- 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.
- 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.
- 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.
- Pregnant or trying to become pregnant; Lack of pregnancy established in females of child-bearing potential by a negative urine pregnancy test at screening.
- 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.
- patients requiring palliative care
- Patients unable to comprehend or follow verbal commands
- premorbid (retrospective) modified Rankin Scale (mRS) score ≥2 of any aetiology;
Tracking Information
- NCT #
- NCT02089464
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Richard L Harvey, MD Shirley Ryan AbilityLab
- Richard L Harvey, MD Shirley Ryan AbilityLab