Anodal Transcranial Direct Current Stimulation on Strength in Subacute Stroke

Stroke Clinical Trial

Official title:

Effects of Anodal Transcranial Direct Stimulation on Strength in Subacute Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05878626
• Other study ID #: REC01355 Hamad
• Status: Completed
• Phase: N/A
• Start date: May 20, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: January 2024
• Source: Riphah International University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Loss of strength is a common complication post stroke which leads to loss of balance and walking ability. Variety of interventions are adopted to improve muscle strength after stroke. These include progressive resistance training, specific task training or functional training, functional electrical stimulation and high intensity aerobic exercises

Description:

Transcranial direct current stimulation (TDCS) is a relatively new treatment approach for stroke recovery. TDCS is a neuromodulation method which involves application of weak direct current stimulations over the scalp via electrodes. It could induce plasticity via modulation of resting membrane potential and modification of spontaneous discharge rate.

TDCS has been shown to have beneficial effects on mobility, muscle strength, motor learning, lower limb function, balance, gait, functionality and walking ability in post stroke patients. TDCS appears to be a promising intervention for stroke patients however its effects are not significant if used in isolation. Thus, it should be used as an adjunct to some other treatment.

Review of available literature indicates TDCS can be a good option in short and intermediate run but its effects in the long run have not been studied yet. Furthermore, to the best of my knowledge there is little literature available about the long-term effects of TDCS on muscle strength in subacute stage. Therefore, this study is designed to test the long-term effects of TDCS stimulation on subacute stroke patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 31, 2023
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 60 Years

Eligibility

Inclusion Criteria:

• Subacute and first MCA stroke

• Ischemic stroke

• Medium to high fall risk on BBS (BBS score = 40)

Exclusion Criteria:

• Hearing and Visual loss/deficit

• Recurrent CVA

• Neurological condition affecting balance like Multiple Sclerosis, Parkinson disease etc

• Wound at skull

• Presence of shunt and/or metallic implant at cranial region

• Brain tumors

• Musculoskeletal conditions affecting lower limbs

• Cognitively compromised

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• Transcranial Direct Current Stimulation
The intensity of TDCS will be 2.5 mA and the duration will be 20 mints. The intervention will be applied twice a day with a time difference of 30 minutes between the two sessions.

Locations

Country	Name	City	State
Pakistan	Rafsan Rehabilitation Center	Peshawar	KPK

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (3)

Dong K, Meng S, Guo Z, Zhang R, Xu P, Yuan E, Lian T. The Effects of Transcranial Direct Current Stimulation on Balance and Gait in Stroke Patients: A Systematic Review and Meta-Analysis. Front Neurol. 2021 May 25;12:650925. doi: 10.3389/fneur.2021.650925. eCollection 2021. — View Citation

Li Y, Fan J, Yang J, He C, Li S. Effects of transcranial direct current stimulation on walking ability after stroke: A systematic review and meta-analysis. Restor Neurol Neurosci. 2018;36(1):59-71. doi: 10.3233/RNN-170770. — View Citation

Saini V, Guada L, Yavagal DR. Global Epidemiology of Stroke and Access to Acute Ischemic Stroke Interventions. Neurology. 2021 Nov 16;97(20 Suppl 2):S6-S16. doi: 10.1212/WNL.0000000000012781. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Manual muscle testing	MMT is used to determine the extent and degree of muscular weakness resulting from disease, injury or disuse. It is an important part of assessment in many patient groups including patients with stroke, spinal cord injury, neuropathy and other neurological and musculoskeletal conditions. The patient can be scored by 5 grades where grade 5 is the patient completes full ROM against maximum resistance from therapist, grade 4 is patient completes full ROM against moderate resistance, grade 3 is patient completes full ROM against gravity, grade 2 is completion of ROM with gravity eliminated, grade 1 is flickering of muscles when movement is attempted and grade 0 is when there is no palpable contraction or flickering. A review on the validity and reliability of MMT reported ICC values of up to 0.96 suggesting it is a reasonably valid tool to assess muscle strength The assessment will be made at baseline, fourth and eighth week	8th week
Secondary	Berg Balance Scale	BBS is used to objectively determine a patient's ability to safely balance during a series of predetermined tasks. It is a 14 item list with each item consisting of a five point scale ranging from 0 to 4, 0 indicating the lowest level of function and 4 indicating the highest level of function. The maximum score is 56 indicating normal function. A score of 41 to 56 indicates mild risk fall, 21 to 40 indicates medium risk fall and 0 to 20 indicates high risk fall. A study on various scales used for assessing balance and function has reported ICC values of 0.99 The assessment will be made at baseline, fourth and eighth week.	8th week