Trials / Completed
CompletedNCT03845595
Cortical Excitability Sequential Changes in Response to Transcranial Magnetic Stimulation Post Stroke
The Sequential Rate of Change in Cortical Excitability in Response to Transcranial Magnetic Stimulation in Stroke Patients
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 40 (actual)
- Sponsor
- Cairo University · Academic / Other
- Sex
- All
- Age
- 50 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
This study was conducted to investigate the cortical excitability changes per session in response to the application of low frequency repetitive transcranial magnetic stimulation \*LF-rTMS\* on the contralesional hemisphere and its impact upon the upper limb motor performance post stroke. As well as, the minimum and maximum number of (LF-rTMS) sessions that would be recommended to achieve boosted enhancement in the cortical excitability findings and subsequently its impact upon the functional performance of the upper limb in stroke patients.Half of the patients were treated with the contralesional (LF-rTMS) in addition to conventional upper limb physical therapy interventions, while the other half received the conventional upper limb physical therapy interventions.
Detailed description
Forty first ever ischemic stroke patients (3 to 6 months) were recruited and randomly assigned into two groups. Intervention for the study group consisted of 10 therapeutic( LF- rTMS) sessions, applied daily for two consecutive weeks in addition to their conventional upper limb physical therapy program. 1-hertz \*HZ\* stimulation was delivered at 90% of the contralesional Active Motor Threshold \*cAMT\* for 20 minutes over the contralesional motor' hot spot'. Sequential cortical excitability changes were examined by recording the contralesional Active Motor Threshold \*cAMT\* and the ipsilesional Active Motor Threshold \*iAMT\* at the end of every session for all patients in both groups throughout the 10 therapeutic consecutive sessions, While the sequential cortical excitability rate of change was measured by calculating the difference in the sessional values of (cAMT and iAMT) between two successive recordings throughout the 10 therapeutic consecutive sessions. Active motor threshold was assessed by the visible election of the contralateral first dorsal interosseous \*FDI\*. Upper limb motor performance was assessed using the Fugal-Myer Assessment Upper Extremity scale \*FMA-UE\* and hand grip dynamometer before and after the whole treatment protocol for all patients in both groups. All the forty patients had successfully accomplished the study procedures. The post treatment findings for cortical excitability and upper limb motor performance declared considerable difference between both groups. It was concluded that Four sessions is the recommended minimal number of (LF-rTMS) sessions that revealed highest significant difference in cortical excitability findings between both groups, relying on both the sessional findings of (cAMT) and the sessional findings of (iAMT). Also, The maximum recommended number of the inhibitory (rTMS) sessions that showed boosted enhancement in cortical excitability in relation to the control group was Eight sessions after which there was a plateau in the findings of the sequential rate of change either for the (cAMT) or the (iAMT) findings. Recovery of the upper limb motor function is closely related to the regain of cortical interhemispheric balance in stroke patients. Further research is needed to reveal whether the sequential changes in cortical excitability is correlated to the stroke onset or the degree of the general motor impairment post stroke. Also, further studies are recommended to figure out whether the recovery of the upper limb motor function is related to implemented number of inhibitory (rTMS) sessions.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | (LF-rTMS) group | The (LF-rTMS) (low frequency repetitive transcranial magnetic stimulation) group received 1-hertz (HZ) stimulation at 90% of motor threshold to the "hot spot" of the primary cerebral cortex, using a 70-mm figure- 8 coil and Magstim Rapid2 stimulator (Magstim Company, USA). Contralesional 1 HZ \*rTMS\* applied over the primary motor area "hot spot" at 90% of Active motor threshold . Each rTMS session consisted of 1,200pulses; lasting 20 minutes The optimal site of stimulation on the skull are known as the "hot spot" . "Hot spots" were found by searching for loci that triggered maximum visible contraction in the contralateral first dorsal interosseous \*FDI\* muscle, while the patient is contracting his whole limb as much as possible . |
| OTHER | Control group | neurodevelopmental technique (NDT) ( including Bobath and Brunnstrom approaches , proprioceptor and exteroceptor stimulation for the weak and inhibition for the hyperactive muscle groups, proprioceptive neuromuscular facilitation (PNF) specific techniques, Approximation and weight bearing, placing technique). Task-oriented training (moving, grasping and releasing bottles ,cups , small toys). Active participation of the whole hemiparetic upper extremity in different motor task training with coordination and Bilateral arm training exercise. |
Timeline
- Start date
- 2018-01-14
- Primary completion
- 2018-09-27
- Completion
- 2018-11-11
- First posted
- 2019-02-19
- Last updated
- 2019-02-19
Locations
1 site across 1 country: Egypt
Source: ClinicalTrials.gov record NCT03845595. Inclusion in this directory is not an endorsement.