Clinical trial NCT03268070: Transcranial Magnetic Stimulation in Stroke Motor Rehabilitation Treatment
Official title: Targeting Motor Areas for Customized Transcranial Magnetic Stimulation in Motor Rehabilitation Treatment of Chronic Stroke Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Keywords: Transcranial Magnetic Stimulation
Neurophysiology
Neuroscience
Stroke Rehabilitation
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2017-08-31
Enrollment: 70
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The goal of the study is to determine the effect of repetitive transcranial magnetic stimulation (rTMS) over the premotor cortex on training-related improvements in motor performance and associated neural plasticity.

Detailed description: Occlusion of the middle cerebral artery is the most common cause of stroke. Because the middle cerebral artery supplies blood to the motor cortices, middle cerebral artery stroke often impacts the integrity of the motor cortex and its associated corticospinal projections. Less than half of all individuals post-stroke regain complete motor function. Because motor deficits, especially of the upper extremities, can dampen the quality of life, there is an urgent need to improve current rehabilitation programs to allow more stroke survivors to achieve higher functional gains.

Motor training is an important part of recovery after stroke. During motor training, patients practice performing a movement and become better at performing the trained movement over time. Repetitive transcranial magnetic stimulation (rTMS), which uses magnetism to excite neurons near the surface of the brain, may further improve performance. There is evidence that the premotor cortex may be a more effective target than the primary motor cortex for rTMS for some stroke survivors. In the current study, the investigator will determine the effect of rTMS over the premotor cortex on training-related improvements in motor performance in adults who experienced a stroke more than 6 months ago.

Eligibility criteria: Inclusion Criteria:

* Have the ability to give informed, written consent
* Be aged 30-80 years old
* Have a single ischemic infarction affecting the primary motor system
* Have intact cognitive abilities
* No current depression
* No neurological disease
* No contradictions to TMS

  * No history of seizures or epilepsy
  * No implanted medical device
  * No metal in neck or head
  * No history of migraine headaches
  * No intake of medication that lowers seizure threshold

Exclusion Criteria:

* none

Primary outcomes:
measure: Change in wrist velocity
timeFrame: Before, 0 mins after, 30 mins after, and 60 mins after motor training.
measure: Change in Stimulus Response Curve parameters
timeFrame: Before, 0 mins after, 30 mins after and 60 mins after motor training.
Secondary outcomes:
measure: Change in wrist force
timeFrame: Before, 0 mins after, 30 mins after, and 60 mins after motor training.
measure: Change in reaction time
timeFrame: Before, 0 mins after, 30 mins after and 60 mins after motor training.
measure: Change in task accuracy
timeFrame: During motor training (will compare first block to last block).
measure: Change in Short interval intracortical inhibition (SICI) of the primary motor cortex
timeFrame: Before, 0 mins after, 30 mins after, and 60 mins after motor training.
measure: Change in Resting Motor Threshold
timeFrame: Before, 0 mins after, 30 mins after, and 60 mins after motor training.
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory Hospital
state: Georgia
Study officials:
affiliation: Emory University
name: Cathrin Buetefisch, MD
role: PRINCIPAL_INVESTIGATOR
References: