Anodal Transcranial Direct Current Stimulation on Strength in Subacute Stroke

NCT ID: NCT05878626

Last Updated: 2024-01-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-20

Study Completion Date

2023-12-31

Brief Summary

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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

Detailed Description

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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.

Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Group A

receive Anodal TDCS with spongy electrodes applied to the M1 (supplementary motor area) of the skull which corresponds to C3 and C4 on the 10/20 EEG system. 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.

Group Type EXPERIMENTAL

Transcranial Direct Current Stimulation

Intervention Type OTHER

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.

Group B

receive conventional treatment in the form of motor relearning program (MRP). And Sham application of anodal TDCS

Group Type SHAM_COMPARATOR

Transcranial Direct Current Stimulation

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Riphah International University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mirza Obaid Baig, MSPT

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

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Rafsan Rehabilitation Center

Peshawar, KPK, Pakistan

Site Status

Countries

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Pakistan

References

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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.

Reference Type BACKGROUND
PMID: 34785599 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34113308 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29439362 (View on PubMed)

Other Identifiers

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REC01355 Hamad

Identifier Type: -

Identifier Source: org_study_id

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