Clinical trial NCT02565199: Premotor Cortex: A New Target for Stroke Motor Rehabilitation
Official title: Premotor Cortex: A New Target for Stroke Motor Rehabilitation Using Transcranial Magnetic Stimulation
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Stroke
Keywords: Transcranial Magnetic Stimulation
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: American Heart Association
First posted: 2015-10-01
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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: Motor training is an important part of recovery after stroke. During motor training, stroke 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. Healthy adults made larger training-related improvements in their motor performance when they received rTMS over the primary motor cortex during motor training. 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 healthy adults.

Eligibility criteria: Inclusion Criteria:

Motor training only (pilot participants):

* Have the ability to give informed, written consent
* Be aged 18-80 years old
* Be right-handed using the Edinburgh handedness inventory
* Have intact cognitive abilities (score higher than 75th percentile on the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS))
* No current depression (score less than 7 on the Hamilton Depression Rating Scale (HDRS))
* No neurological disease
* No contradictions to Transcranial Magnetic Stimulation (TMS)
* TMS over the extensor carpi ulnaris (ECU) hotspot must evoke a motor evoked potential (MEP) in the ECU muscle
* MEP amplitude must increase by at least 20% as the TMS intensity increases
* The subjects must be comfortable when receiving TMS of all strengths.

Remaining study participants:

* Have the ability to give informed, written consent
* Be aged 55-80 years old
* Be right-handed using the Edinburgh handedness inventory
* Have intact cognitive abilities (score higher than 75th percentile on the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS))
* No current depression (score less than a 7 on the Hamilton Depression Rating Scale (HDRS))
* No neurological disease
* No contradictions to Transcranial Magnetic Stimulation (TMS)
* TMS over the extensor carpi ulnaris (ECU) hotspot must be able to evoke a motor evoked potential (MEP) in the ECU muscle
* MEP amplitude must increase by at least 20% as the TMS intensity increases
* The subjects must be comfortable when receiving TMS of all strengths.

Exclusion Criteria:

* Impaired cognitive abilities (score lesser than 75th percentile on the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS))
* Current depression (score more than 7 on the Hamilton Depression Rating Scale (HDRS))
* Neurological disease
* Has a contradiction to TMS
* MEP cannot be evoked with TMS in the ECU muscle
* Inability to tolerate one or more TMS strengths

Primary outcomes:
measure: Change in wrist acceleration
timeFrame: Baseline, post-motor training (1 minute, 30 minutes and 60 minutes after completion of motor training)
measure: Change in stimulus response curve (SRC)
timeFrame: Baseline, post-motor training (1 minute, 30 minutes and 60 minutes after completion of motor training)
measure: Change in short interval intracortical inhibition (SICI)
timeFrame: Baseline, post-motor training (1 minute, 30 minutes and 60 minutes after completion of motor training)
Secondary outcomes:
measure: Change in wrist force
timeFrame: Baseline, post-motor training (1 minute, 30 minutes and 60 minutes after completion of motor training)
measure: Change in reaction time
timeFrame: Baseline and post-motor training (1 minute, 30 minutes and 60 minutes after completion of motor training)
measure: Change in task accuracy
timeFrame: Baseline and post-motor training (1 minute after completion of motor training)
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University
state: Georgia
Study officials:
References: