Structurally Reorganizing Motor Cortex in Stroke Patients Through Hebbian-type Stimulation

Browse trials for

• Stroke 7,286

Keywords

• Neurophysiology
• Transcranial Magnetic Stimulation (TMS)
• Neurology
• Stroke
• Physical Medicine and Rehabilitation

Stroke

7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.

This study's enrollment of 48 is close to the median of 50 across 5,369 interventional studies indexed under Stroke.

Lead sponsor

Cathrin Buetefisch is the lead sponsor of 2 studies on the registry; none are open to participants now.

Eligibility criteria

Study arms

• Experimental
  Hebbian-type Stimulation

  Participants will be randomized to receive motor training with Hebbian-type stimulation.

  Device: Repetitive Transcranial Magnetic Stimulation (rTMS)

• Sham comparator
  Sham Stimulation

  Participants will be randomized to receive sham stimulation.

  Device: Sham stimulation

Interventions

• DeviceRepetitive Transcranial Magnetic Stimulation (rTMS)

  Training sessions for 5 days in a row

• DeviceSham stimulation

  Sham stimulation

Primary outcomes

1. Primary Motor Cortex (M1) Excitability Derived From Stimulus Response Curve

   Motor evoked potential (MEP) amplitudes were measured prior to treatment (baseline), one week after the treatment (post-training 1), and 4 weeks after treatment (post-training 2).The MEP is elicited by transcranial magnetic stimulation (TMS) at increased intensity. Its amplitude is measured from peak to peak and expressed in millivolts (mV). Measured MEP amplitudes were plotted against the intensity to create a stimulus response curve (SRC). Long-lasting increases in MEP amplitude indicate increases in motor cortex excitability and are associated with motor learning.

   Time frame: Baseline, Post-Training 1 (1 Week), Post-Training 2 (4 Weeks)

Secondary outcomes

1. Mean Time to Completion for Jebsen Hand Function Test (JTT)

   The JTT provides a standardized and objective evaluation of fine and gross motor hand function using simulated activities of daily living assessing the speed of performance. Total score is the sum of time taken for each sub-test, which were normalized to standard scores (also expressed in seconds).Total scores range from +1 to -1 where -1 indicates best function.

   Time frame: Baseline, Post-Training (1 Week), Post-Training (4 Weeks)

2. Mean Peak Acceleration of Wrist Extension Movements

   Mean peak acceleration was measured at baseline, one week after the treatment (post-training 1), and four weeks after the treatment (post-training 2). Increases in the mean peak acceleration of the trained wrist extension movements indicate motor learning. Acceleration was measured in g; a symbol for the average acceleration produced by gravity at the Earth's surface.

   Time frame: Baseline, Post-Training (1 Week), Post-Training (4 Weeks)

3. Mean Reaction Time of Wrist Extension Movements

   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. A longer time indicated longer time to reaction.

   Time frame: Baseline, Post-Training (1 Week), Post-Training (4 Weeks)

4. Mean Motor Activity Log (MAL) Score: Amount Subtest

   Individuals are asked to rate amount of movement during 30 daily functional tasks. Items are scored on a 0 to 6-point ordinal scale as follows: 0 = The weaker arm was not used at all for that activity (never) 1 = Occasionally used weaker arm, but only very rarely (very rarely) 2= Sometimes used weaker arm, but did the activity most of the time with stronger arm (rarely) 3 = Used weaker arm about half as much as before the stroke (half pre-stroke) 4 = Used weaker arm almost as much as before the stroke (3/4 pre-stroke) 5 = The ability to use the weaker arm for that activity was as good as before the stroke (normal) Total scores range from 0 to 140; 0 indicating the least movement 140 indicating the most movement. The scores were converted into percentage scores where higher percent score indicate more movement and lower percent score less movement.

   Time frame: Baseline, Post-Training (1 Week), Post-Training (4 Weeks)

5. Mean Motor Activity Log (MAL): How Well Subtest

   Individuals are asked to rate quality of movement during 30 daily functional tasks. Items are scored on a 6-point ordinal scale as follows: 0=The weaker arm was not used at all for that activity (never); 1=The weaker arm was moved during that activity, but was not helpful (very poor); 2=The weaker arm was of some use during the activity, but needed help from the stronger arm or moved very slowly or with difficulty (poor); 3=The weaker arm was used for the purpose indicated, but movements were slow or were made with only some effort (fair); 4=The movements made by the weaker arm were almost normal, but were not quite as fast or accurate as normal (almost normal); 5=The ability to use the weaker arm for that activity was as good as before the stroke (normal) Total scores range from 0 to 140; 0 indicating the least movement and 140 indicating the most movement.

   Time frame: Baseline, Post-Training (1 Week), Post-Training (4 Weeks)

6. Mean Wolf Motor Function Test (WMFT) Total Time

   The Wolf Motor Function Test (WMFT) is a quantitative index of upper extremity motor ability examinable through the use of timed and functional tasks. There are 15 timed tasks included with a time cap of 120 seconds. The max amount of time to completion is 1800 seconds if all tasks are failed. The time in seconds were summed across all the tasks to obtain the total duration. Values in the table represent the time taken in seconds to successfully complete all 15 tasks).

   Time frame: Baseline, Post-Training (1 Week), Post-Training (4 Weeks)

7. Mean Wolf Motor Function Test Functional Ability (WMFT-FS) Scale Score

   The WMFT is a 17 item scale that quantifies upper extremity (UE) motor ability through timed and functional tasks. The items are rated on a 6-point scale.Total scores can range from 17 to 102. Lower scores indicate debilitating mobility (such as no or limited functionality), while higher score indicate greater mobility (such as slow movement and normal movement).

   Time frame: Baseline, Post-Training (1 Week), Post-Training (4 Weeks)

8. Mean Wolf Motor Function Test (WMFT) Grip Strength

   Participants attempt to grip the dynamometer with greatest grip strength possible. The test should be conducted 3 times with a 1-minute rest between trials. The mean of grip strength exerted (kg) on 3 trials is then calculated.

   Time frame: Baseline, Post-Training (1 Week), Post-Training (4 Weeks)

Baseline characteristics

Publications

• Revill KP, Haut MW, Belagaje SR, Nahab F, Drake D, Buetefisch CM. Hebbian-Type Primary Motor Cortex Stimulation: A Potential Treatment of Impaired Hand Function in Chronic Stroke Patients. Neurorehabil Neural Repair. 2020 Feb;34(2):159-171. doi: 10.1177/1545968319899911. Epub 2020 Jan 24. PubMed 31976804 ↗