Effects of High Frequency rTMS Combined Motor Learning on Upper Limb Motor Function in Subacute Stroke

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages Any age
• All sexes
• No healthy volunteers
• Child, Adult, Older adult

About this study

Official title: Effects of High Frequency Repetitive Transcranial Magnetic Stimulation Combined Motor Learning on Motor Function and Grip Force for Upper Limbs and Activities of Daily Living in Sub-acute Stroke Patients

Conditions

Stroke, Acute, Hemiplegia

Being tested

HF-rTMS, ML, Sham-rTMS

Medical subject headings

Stroke, Hemiplegia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• HF-rTMSDevice

  Also called High Frequency repetitive Transcranial Magnetic Stimulation(HF-rTMS)

  HF-rTMS stimulated a 70-mm, 8-shaped coil stimulator (The Magstim Company, UK, 2012) on the damaged cerebral cortex. Prior to the application of HF-rTMS, the motor point was identified that stimulates maximum thresholds on the primary motor cortex, causing flexion of the opposite index finger. If the cerebral hemisphere does not show a kinetic response even at the maximum stimulus, the motor point of the opposite hemisphere was found to be symmetrically changed. The intensity of the stimulus was 80% of the resting motor threshold, which means the motor eveked potential above which the first dorsal interosseous muscle can produce 50 μV more than five times out of 10 stimuli. The subject sat on a chair made to hold the head. The stimulation was stimulated at high frequency (10 Hz) for 2 seconds, and the rest was performed for 58 seconds for a total of 200 times for 10 minutes.

• MLBehavioural

  Also called Motor Learning(ML)

  Motor learning was conducted for two minutes each in five sessions, and the first is the external rotation training to maximum range of the shoulder joint in sitting position. The second method is to stack cups by transferring them from the non-affected side to the affected side by transferring 25 plastic cups of five colors in sitting position with both hands inserted. Third, by pushing and pulling the ball forward and backward with the hands folded, the subject puts a 55 cm healing ball on the table in a sitting position, and pushes and pulls it forward with the upper limb. The fourth method is to insert and remove pegs from the peg board, and the target uses the affected side hand in sitting position. The fifth method is to tear a newspaper, in which the subject overlaps a newspaper on the table in a sitting position, holds it with the non-affected hand, and tears it with the hands of the damage. A total of 10 minutes of motor learning.

• Sham-rTMSDevice

  Also called Sham repetitive Transcranial Magnetic Stimulation(Sham-rTMS)

  Sham rTMS gives a small intensity of 2% of the resting motor threshold that cannot cause excitement in the motor cortex, and is set to listen to the same frequency of noise as HF-rTMS, and motor learning is applied equally. A total of 20 minutes were applied three times a week for four weeks by applying 10 minutes of Sham rTMS and 10 minutes of motor learning.

What is being measured

The primary outcome is the main question the study is designed to answer.

1. Fugl Meyer Assessment - Upper Limb(FMA-U/L)

   The FMA-U/L score is a tool for evaluating the body's structure, function, and activity level as an evaluation tool for evaluating motor function according to Brunnstrom's recovery phase of Step 6. The minimum value is 0 point and the maximum value is 66 points, and the higher the score, the better the outcome.

   Measured: Change from baseline at the end of four weeks intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted4 Jan 2022
2. Study start13 May 2016
3. Primary completion29 Jul 2016
4. Study completion5 Aug 2016

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for Stroke, AcuteStudies of the same condition, open and under way.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.