Clinical trial NCT02465034: Noninvasive Brain Stimulation to Evaluate Neural Plasticity After Stroke
Official title: Noninvasive Brain Stimulation to Evaluate Neural Plasticity After Stroke
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cerebrovascular Stroke
Keywords: Neural plasticity
Noninvasive brain stimulation
Motor cortex
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2015-06-08
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to examine how different areas in the brain interact with each other and how using brain imaging and brain stimulation approaches can influence these interactions.

Detailed description: Subcortical strokes affect small vessels deep in the brain, and typically present with motor hemiparesis. The investigator will assess the effects of Transcranial Magnetic Stimulation (TMS) on motor function and examine how different areas in the human brain interact with each other using brain imaging and brain stimulation. The investigator will also evaluate the capacity for noninvasive stimulation to transiently modify brain activity supporting arm movement.

Eligibility criteria: Inclusion Criteria:

1. Age between 18-85 years
2. Middle cerebral artery stroke
3. Individuals with a first time stroke that affects the corona radiata and/or internal capsule

Exclusion Criteria:

1. Age outside the age range of 18-85 years
2. Signs of dementia (score \< 24 on the Montreal Cognitive Assessment)
3. Aphasia (score \< 13 on the Frenchay Aphasia Screen)
4. History of head trauma
5. History of a major psychiatric diagnosis
6. History of a neurodegenerative disorder
7. History of substance abuse
8. Contraindications to Transcranial Magnetic Stimulation

Primary outcomes:
measure: Change in Long-term Potentiation-like Plasticity
timeFrame: Baseline, 1 Minute Post-Paired Associative Stimulation
measure: Electroencephalography Recordings at Baseline and 5 MInutes Post-PAS
timeFrame: Baseline, 5 Minutes Post-Paired Associative Stimulation
measure: Abbreviated Wolf Motor Function Test Time
timeFrame: Baseline, 10 Minutes Post-Paired Associative Stimulation
Secondary outcomes:
measure: Wolf Motor Function Test
timeFrame: Baseline
measure: Abbreviated Wolf Motor Function Test Time
timeFrame: 30 minutes post-Paired Associative Stimulation, 24 hours post-Paired Associative Stimulation
measure: Long-term Potentiation-like Plasticity
timeFrame: 30 minutes post-Paired Associative Stimulation, 24 hours post-Paired Associative Stimulation
measure: Electroencephalography Recordings at 30 Minutes and 24 Hours Post-PAS
timeFrame: 30 minutes post-Paired Associative Stimulation, 24 hours post-Paired Associative Stimulation
measure: Serial Reaction Time Task (SRTT) Performance
timeFrame: Baseline, 10 minutes post-PAS, 30 minutes post-PAS, and 24 hours post-PAS
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Atlanta
country: United States
facility: Wesley Woods Center
state: Georgia
Study officials:
affiliation: Emory University
name: Michael Borich, DPT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Borich MR, Wolf SL, Tan AQ, Palmer JA. Targeted Neuromodulation of Abnormal Interhemispheric Connectivity to Promote Neural Plasticity and Recovery of Arm Function after Stroke: A Randomized Crossover Clinical Trial Study Protocol. Neural Plast. 2018 Mar 12;2018:9875326. doi: 10.1155/2018/9875326. eCollection 2018.