Transcranial Magnetic Stimulation in Stroke Motor Rehabilitation Treatment

Not Applicable

Not yet recruiting

• Conditions: Stroke
• Interventions: Device: Repetitive TMS over ipsilateral premotor cortex.; Device: Single TMS over extensor carpi ulnaris spot of motor cortex; Device: Repetitive TMS over contralateral premotor cortex.; Device: Repetitive TMS over contralateral primary motor cortex.; Device: Sham Repetitive TMS over contralateral premotor cortex.

• Registration Number: NCT03268070
• Lead Sponsor: Emory University

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.

Study Timeline

• Study First Submitted: 2017-08-29
• Study First Submitted QC: 2017-08-29
• Study First Posted: 2017-08-31
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-06
• Last Update Posted: 2023-03-07
• Study Start: 2024-02
• Primary Completion: 2025-02
• Study Completion: 2025-02

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 70

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

Read More

Exclusion Criteria

• none

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Repetitive TMS over ipsilateral premotor cortex	Repetitive TMS over ipsilateral premotor cortex.	Location of repetitive Transcranial Magnetic Stimulation (rTMS): ipsilateral premotor cortex.
Single TMS over extensor carpi ulnaris spot of motor cortex	Single TMS over extensor carpi ulnaris spot of motor cortex	Location of single-pulse Transcranial Magnetic Stimulation (sTMS): extensor carpi ulnaris (ECU) hotspot of primary motor cortex (M1).
Repetitive TMS over contralateral premotor cortex	Repetitive TMS over contralateral premotor cortex.	Location of repetitive Transcranial Magnetic Stimulation (rTMS): contralateral premotor cortex.
Repetitive TMS over contralateral primary motor cortex	Repetitive TMS over contralateral primary motor cortex.	Location of repetitive Transcranial Magnetic Stimulation (rTMS): contralateral primary motor cortex.
Sham repetitive TMS over contralateral premotor cortex	Sham Repetitive TMS over contralateral premotor cortex.	Location of Sham repetitive Transcranial Magnetic Stimulation (rTMS): contralateral premotor cortex.

Primary Outcome Measures

Name	Time	Method
Change in Stimulus Response Curve parameters	Before, 0 mins after, 30 mins after and 60 mins after motor training.	To measure organization of a motor region in the primary motor cortex supporting wrist movement, a Stimulus Response Curve (SRC) will be collected before and after motor training. SRC is a set of motor evoked potentials (MEP) that characterizes input-output parameters of the primary motor cortex and associated corticospinal tract. A change in the SRC parameters after training will reflect a change in the organization of the primary motor cortex.
Change in wrist velocity	Before, 0 mins after, 30 mins after, and 60 mins after motor training.	The subjects will be asked to perform 7 isometric wrist extensions before and after motor training. Wrist velocity will be measured by a gyroscope taped to the dorsum of the wrist that was used during motor training. An increase in the maximum velocity that persists at least an hour after training is indicative of motor learning.

Secondary Outcome Measures

Name	Time	Method
Change in reaction time	Before, 0 mins after, 30 mins after and 60 mins after motor training.	Subjects will be asked to perform 7 auditory-cued ballistic wrist extensions before and after motor training. Electromyographic (EMG) activity recorded during the ballistic wrist extensions will be used to measure reaction time. Reaction time is the length of time between the auditory cue and the onset of the movement-related EMG burst of the extensor carpi ulnaris muscle.
Change in Short interval intracortical inhibition (SICI) of the primary motor cortex	Before, 0 mins after, 30 mins after, and 60 mins after motor training.	Short interval intracortical inhibition (SICI) is an inhibitory phenomenon in the motor cortex. To test for SICI, a sub-threshold conditioning stimulus (CS) will precede a supra-threshold test stimulus (TS) by 2 milliseconds. The amplitude of a conditioned TS-evoked MEP will be expressed as a percent of the amplitude of an unconditioned TS-evoked MEP (% MEP). A decrease in the % MEP after training would indicate a increase in SICI. An increase in the % MEP after training would indicate a decrease in SICI.
Change in Resting Motor Threshold	Before, 0 mins after, 30 mins after, and 60 mins after motor training.	Parametric Estimation by Sequential Testing (PEST) will be used to determine the Resting Motor Threshold (rMT). The mathematical algorithm implemented by PEST will determine the rMT with fewer TMS pulses than the traditional method.
Change in task accuracy	During motor training (will compare first block to last block).	Task accuracy will be determined by the number of successful trials over the number of total trials. A trial will be considered successful when the subject moves a cursor from the home position into a target box by modulating the acceleration of their wrist. An increase in task accuracy after training will indicate motor learning.
Change in wrist force	Before, 0 mins after, 30 mins after, and 60 mins after motor training.	The subjects will be asked to perform 7 isometric wrist extensions before and after motor training. A force transducer will record the maximum force produced during the wrist extensions.

Trial Locations

Locations (1)

Emory Hospital; 🇺🇸 Atlanta, Georgia, United States