Contrastim Stroke Trial

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Stroke

In brief

This is a prospective randomized controlled feasibility study to determine whether navigation guided repetitive transcranial magnetic stimulation (rTMS) to the healthy hemisphere in patients with subacute stroke has a beneficial effect when given concurrently with task-oriented motor rehabilitation of the arm and hand. Navigation guided rTMS requires a structural MRI scan for targeting stimulation and therefore structural MRI will be performed on all subjects. In addition the study intends to determine whether measures of motor tract integrity (MTI) assessed by navigated brain stimulation (NBS) and MRI diffusion tensor imaging can be used to clarify prognosis of motor recovery and to monitor progress with rehabilitation. 30 subjects with ischemic or hemorrhagic stroke 3-9 months prior to enrollment and with residual upper limb hemiplegia will be randomized to receive either 1 Hz rTMS to the contralesional hemisphere for 30 minutes 3 times a week for 6 weeks along with rehabilitation therapy or sham rTMS to the contralesional hemisphere for 30 minutes 3 times a week for 6 weeks along with rehabilitation therapy. Primary outcome is improvement on the Action Research Arm Test, a measure of arm and hand function in people with stroke. Outcomes will be measured immediately post treatment, and at 3 months and 6 months post treatment.

Key facts

Study ID

NCT01049802

Run by

Shirley Ryan AbilityLab

People needed

30

Starts

2010-01-01

Expected to finish

2016-09-01

Last updated by the study team

2016-12-29

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥ 18 years of age
• An ischemic or hemorrhagic stroke suffered 3-9 months prior to the study
• no other known brain abnormalities by history or by structural MRI
• A one-sided stroke resulting in upper extremity paresis
• A Chedoke Arm and Hand Activity Inventory score of 3-6 for the affected limb

You may not qualify if…

• Implanted metallic parts of implanted electronic devices, including pacemakers, defibrillators, or implant medication pump
• Pregnant or trying to become pregnant
• History of alcohol abuse, illicit drug use or drug abuse or significant mental illness
• any history of epilepsy
• Any condition that would prevent the subject from giving voluntary informed consent
• An implanted brain stimulator
• Aneurysm clip or other metal in body
• Enrolled or plans to enroll in an interventional trial during this study
• Scalp wounds or infections
• Claustrophobia precluding MRI
• A fixed contraction deformity in the affected limb
• Excessive spasticity as indicated by the Modified Ashworth Spasticity (MAS) Scale >2/4 in the affected limb
• previous stroke with residual deficits (TIAs not a reason for exclusion)
• premorbid (retrospective) modified Rankin Scale (mRS) score ≥2 of any aetiology
• 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
• patients requiring palliative care
• patients undergoing any other occupational therapy than what is provided in the study
• A recent injection of botulinum 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
• Ataxia as measured by a score > 1 on item 7 (limb ataxia) of the NIH stroke scale
• Severe aphasia as measured by a score of > 2 on item 9 (best language) of the NIH stroke scale
• Severe neglect as measured by a score of 2 on item 11 (extinction and inattention) of the NIH stroke scale

Where it is running

• The Rehabilitation Institute of Chicago — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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