NCT04770363

Comparison Between Unihemispheric and Bihemispheric TCDS in Subacute Ischemic Stroke Patients

Comparison Between the Effect of Unihemispheric and Bihemispheric Transcranial Direct Current Stimulation on Spasticity and Motor Outcome in Subacute Ischemic Stroke Patients: as Add on Therapy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Alexandria University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized clinical trial to study the effect of tDCS in participants with subacute ischemic stroke, the study participants will be randomly assigned into three groups; bihemispheric, unihemispheric and sham group.

Detailed description

Despite the central origin of stroke affecting the primary motor cortex M1, majority of the rehabilitative techniques of physical therapy and occupational therapy practice depending peripheral methods for gaining motor functions. There is a great need to develop methods in order to improve the outcome of physical or medical rehabilitation and enhance long-term functional outcome. Many researches' work over the past several years have inspected the use of transcranial direct current stimulation (tDCS) to promote the advantageous effect of neurological rehabilitation. The aim of This study Is to compare between the effect of unihemispheric and bihemispheric tDCS on the motor outcome, and spasticity in sub-acute ischemic stroke patients. Thirty sub-acute ischemic stroke patients participated in the study, randomly assigned to one of three groups-tDCS bihemispheric or unihemispheric or sham group. Those patients had stroke in the last 3 months at maximum with NIH stroke score less than 25. ActivaDose tDCS (USA), the only FDA cleared device available for tDCS used in the clinical study to deliver noninvasive brain stimulation, consisted of 20 minutes of 2 mA in each session for twelve sessions three sessions per week. All participants received physiotherapy and rehabilitation therapy was tailored to meet all patients' deficits, and lasted a total of 45 minutes per day, 3 days per week for four weeks.

Conditions

• Stroke, Ischemic
• Stroke, Acute
• Stroke, Lacunar
• Hemiparesis
• Hemiplegia
• Motor Activity
• Spastic
• Spasticity, Muscle
• Hemiplegic Gait

Interventions

Type	Name	Description
DEVICE	Transcranial Direct Current Stimulation (tDCS)	Transcranial direct current stimulation (tDCS) is an emerging non-invasive brain stimulation technique which has been utilized in examining cortical function in healthy subjects and also showed significant outcome in neurological rehabilitation. A safe, portable, noninvasive painless, reversible, selective and focal brain stimulation technique, applied by sponge electrodes over the scalp. tDCS is capable of modulating the excitability of targeted brain zones through delivering a sustained direct current (DC), showed altering neuronal membrane potentials based on the polarity of the current. Researchers demonstrated modulating effects of anodal (increases cortical excitability) and cathodal (decreases cortical excitability) tDCS on brain tissue. The expected effects of tDCS brain stimulation exceeds the duration. Animal studies showed neuronal depolarization and increasing neuronal excitability of the anodal stimulation, and opposite results with cathodal stimulation.

Timeline

• Start date: 2021-02-01
• Primary completion: 2021-05-30
• Completion: 2021-06-20
• First posted: 2021-02-25
• Last updated: 2023-03-27

Locations

1 site across 1 country: Egypt

Regulatory

• FDA-regulated device study