Feasibility of Enhancing Recovery of Sensory Deficits After Stroke With rTMS

Cerebrovascular Accident Clinical Trial

Official title:

Feasibility of Enhancing Recovery of Sensory Deficits After Stroke With rTMS

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04535232
• Other study ID #: IRB 12025-H13
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 2013
• Est. completion date: April 2021

Study information

• Verified date: August 2020
• Source: Louis Stokes VA Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Problem: Stroke is a leading cause of disability in the United States . Motor deficits caused by stroke are commonly paired with loss of sensory perception. Sensory deficits significantly impair functional activity and slow down motor recovery during rehabilitation. Several studies demonstrated that for individuals whose sensation was preserved, motor recovery was achieved faster. The main objective of this study is to test the feasibility and preliminary efficacy of novel approach to treat sensory deficits after stroke with combination of repetitive Transcranial Magnetic Stimulation (rTMS) and peripheral arm and hand sensory therapy. Rationale: Sensory deficits can be partially recovered with peripheral manipulation of skin, muscles and joints using sensory re-education-based rehabilitation. Sensory re-education is associated with adaptive functional and structural alterations in the brain, called neuroplasticity. Despite mechanisms of reorganization, sensory recovery is usually slow and incomplete. There is a non-invasive method of brain modulation, called repetitive Transcranial Magnetic Stimulation (rTMS) that can potentially drive the adaptive functional and structural brain changes that lead to functional improvements. Although rTMS of motor control regions has been shown to enhance motor rehabilitation after stroke, evidence in support of enhancement of sensory abilities is only preliminary and rTMS has not been tested to treat sensory deficits. We propose to test the feasibility and preliminary efficacy of rTMS targeting sensory cortical regions to augment effectiveness of sensory rehabilitation. Study Design. We propose to enroll a total of up to 16 individuals with sensory deficits after a first ever stroke (stroke onset > 6 months prior). Subjects will be treated with 5 sensory treatment sessions one week apart that will consist of rTMS with the peripheral sensory re-education rehabilitation therapies (vibration and functional electrical stimulation of the affected arm). rTMS be either facilitatory or inhibitory and will target contralesional primary sensory region. The First Hypothesis is that a combination of rTMS and sensory re-education therapy results in a greater improvement of sensory deficits than sensory therapy alone. We will test this hypothesis by comparing subject's sensory evaluation results between the active and sham rTMS treatment sessions. Sensory evaluation will include a battery of sensory testing measures. The Second Hypothesis is that a combination of facilitatory rTMS and peripheral sensory therapy leads to functional brain changes. We will test this hypothesis by measuring functional brain changes using somatosensory evoked potential (SEP) induced by median nerve stimulation. Overall, the study is designed as a proof of concept to be used for development of a novel approach for sensory rehabilitation after stroke.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 16
• Est. completion date: April 2021
• Est. primary completion date: April 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Medically stable at least 6 months after first ever stroke.

2. Sufficient endurance to participate in the study.

3. Cognition sufficiently intact to give valid informed consent to participate.

4. Age > 18years.

5. Ability to follow 2 stage commands.

6. Impaired but not absent ability to feel touch, vibration and movement of the affected arm.

Exclusion Criteria:

1. Acute or progressive cardiac, renal, respiratory, neurological disorders or malignancy.

2. Any psychiatric diagnosis or active psychological condition.

3. History of substance abuse within the last 6 months

4. More than one ischemic stroke or stroke affecting both sides.

5. Contraindications for MRI.

6. Lower motor neuron damage or radiculopathy

7. Contraindications for rTMS.

8. Inability to understand English.

Related Conditions & MeSH terms

• Cerebrovascular Accident
• CVA
• Stroke

Intervention

Other:
• rTMS and peripheral sensory re-education
repetitive Transcranial Magnetic Stimulation (rTMS) is a non-invasive method of brain modulation while sensory re-education therapy consists of using vibration and sensory level electrical stimulation of the upper limb.

Locations

Country	Name	City	State
United States	Louis Stokes Cleveland Department of Veterans Affairs Medical Center	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Louis Stokes VA Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	somatosensory evoked potentional (SEP)	SEP is a measure of functional brain changes. The SEP is induced by median nerve stimulation and short-latency afferent inhibition.	change from pre interevention to immediately after the intervention
Primary	Sensory evaluation	the sensory evaluation will include a tactile acuity test(monofilament discrimination sensory test) and a test of proprioception.	change from pre interevention to immediately after the intervention