CClinicalTrials.gg
RecruitingNCT06598683Updated Mar 24, 2025

tDCS and Spasticity in Stroke Patients

An interventional study of tDCS and Conventional in Stroke, sponsored by Riphah International University. Recruiting at 2 sites in Pakistan. Open to participants aged 30 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-03-24.

Sponsored by Riphah International University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jun 2025, 1 year 3 months ago, but the record still lists the study as recruiting.
  • Started Oct 2024; still recruiting 2 years later.
Phase
Not applicable
Study type
Interventional
Enrollment
56
Allocation
Randomized
Ages
30 Years to 70 Years
Sex
All
01

Study summary

Multiple research has worked on tDCS and its impact on stroke. But none have studied the effects of tDCS on stroke in relation to the different stages of stroke like mild, moderate, moderate to severe and severe stroke as per national institute of health (NIH) scale.

Additionally, this study will be conducted to address the few drawbacks in previous studies such as short follow up period by employing evidence based standardized protocols. It can potentially instigate the efficacy of tDCS on spasticity, motor recovery and Quality of life in relation to the different severity levels of stroke.

Read the detailed description

Multiple noninvasive brain stimulation is also introduced over the few years regarding their impact on spasticity, tDCS being the most common due to its effects on spasticity. There are multiple structural and functional changes in motor cortex post stroke, tDCS causes improvement in motor control by reorganizing the motor cortex. Anodal and cathodal tDCS are based on the current direction with cathodal decreasing excitability of the cortex area and anodal increasing it. Anodal tDCS is more effective in reducing spasticity as compared to cathodal. The change in cortical excitation alters the reflex arc i.e. altering the neurons and reducing their excitability which causes a decrease in tone and facilitates neuroplasticity.

Spasticity is often found along with weakness in stroke and is one of the reasons for impaired motor function, increased resistance to stretch and is due to increased excitability and abnormal regulation of spindle and reflex arc. With chronicity and reduced motor control spasticity also increases by 97 %. Spasticity and paresis lead to impaired motor control. Spasticity will not change recovery in function in early stages but is going to affect motor recovery in all stages. Spasticity disrupts motor function and the daily tasks which creates different levels of dependence in the patients hence effecting the QOL. Spasticity is found in almost 40% of individuals suffering from stroke. It affects joints and extremities in a way that impedes function and ADLs. Painful, restricted joints resulting from prolonged spasticity badly impacts the QOL leading to high burden on caregivers

02

Conditions studied

  • Stroke

Keywords

  • Stroke
  • spasticity
  • transcranial direct current stimulation
03

In context

Muscle Spasticity

704 studies on the registry are indexed under Muscle Spasticity; 149 are open to participants now.

This study's planned enrollment of 56 is above the median of 36 across 525 interventional studies indexed under Muscle Spasticity.

Browse Muscle Spasticity studies →

Lead sponsor

Riphah International University is the lead sponsor of 2,133 studies on the registry; 633 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Stroke for more than 6 months.
  • Both genders.
  • Spasticity score ≥1 at modified ashworth scale.
  • National Institutes of Health Stroke Scale (NIHSS) for severity level; Mild (1-4), Moderate (5-15), Moderate to Severe (16-20), Severe (21-42)

Exclusion criteria

Exclusion Criteria:

  • Have any metallic implant including intracranial electrode, pacemaker, surgical clip.
  • Any symptoms effecting understanding of instructions.
  • Any neurological disorder
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
56 participants (estimated)

Study arms

  • Experimental
    tDCS

    Other: tDCS · Other: Conventional

  • Active comparator
    Conventional

    Other: Conventional

Interventions

  • OthertDCS

    Stimulation in each session will be applied for 20 min by two 5 × 4 cm (20 cm2) saline-soaked sponge electrodes at an intensity of 1.5 mA (0.075 mA/cm2). A gradual ramp up and down of stimulation for 10 s at the beginning and the end of stimulation

  • OtherConventional

    ROM exercises for upper and lower extremities, Stretching of agonists, Strengthening of antagonists, Core stability exercises, Static and dynamic balance activities, Gait training, Functional training

06

What researchers measure

Primary outcomes

  1. Modified Ashworth Scale

    MAS is a tool to measure hypertonia. It scores the resistance on a 5 point ordinal scale with an increase value indicating hypertonia. Intrarater reliability of MAS was found to be good to excellent for upper (k= 0.71-0.94) and lower extremities(k= 0.55-0.97) while interrater reliability was poor to moderate for upper (k= 0.25-0.66)and lower extremities (k= 0.41-0.54)

    Time frame: 8 week

  2. Fugl Meyr Assessment

    FMA is used for the assessment of physical performance and sensorimotor function of neurological patients. It uses a 3-point ordinal scale to score individuals' ability to perform a certain task. Total score is 226. It has excellent inter and intrarater reliability. (ICC 0.95)

    Time frame: 8 week

Secondary outcomes

  1. SS-QoL

    It is used for estimating the quality of life of stroke patients. It contains 49 questions related to different personal and social aspects. Scoring is done on a ordinal scale of 1-5 with an increase score indicating independence. It is a valid and reliable tool to use in stroke population (Cronbach's alpha 0.903)

    Time frame: 8 week

07

Study locations

1 of 2 sites recruiting
  • Pakistan Railway General Hospital
    Rawalpindi, Punjab 466000, Pakistan
    Not yet recruiting
  • Pakistan Railway Hospital
    Rawalpindi, Punjab, Pakistan
    Recruiting
08

References and documents

Publications

  • Zeng H, Chen J, Guo Y, Tan S. Prevalence and Risk Factors for Spasticity After Stroke: A Systematic Review and Meta-Analysis. Front Neurol. 2021 Jan 20;11:616097. doi: 10.3389/fneur.2020.616097. eCollection 2020. PubMed 33551975 ↗
  • Cheng H, Fang X, Liao L, Tao Y, Gao C. Prevalence and factors influencing the occurrence of spasticity in stroke patients: a retrospective study. Neurol Res. 2023 Feb;45(2):166-172. doi: 10.1080/01616412.2022.2127249. Epub 2022 Sep 25. PubMed 36153827 ↗
  • Lackritz H, Parmet Y, Frenkel-Toledo S, Banina MC, Soroker N, Solomon JM, Liebermann DG, Levin MF, Berman S. Effect of post-stroke spasticity on voluntary movement of the upper limb. J Neuroeng Rehabil. 2021 May 13;18(1):81. doi: 10.1186/s12984-021-00876-6. PubMed 33985543 ↗
  • Li S, Francisco GE, Rymer WZ. A New Definition of Poststroke Spasticity and the Interference of Spasticity With Motor Recovery From Acute to Chronic Stages. Neurorehabil Neural Repair. 2021 Jul;35(7):601-610. doi: 10.1177/15459683211011214. Epub 2021 May 12. PubMed 33978513 ↗
  • Wang X, Ge L, Hu H, Yan L, Li L. Effects of Non-Invasive Brain Stimulation on Post-Stroke Spasticity: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Brain Sci. 2022 Jun 27;12(7):836. doi: 10.3390/brainsci12070836. PubMed 35884643 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 24, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06598683
Lead sponsor
Riphah International University
Responsible party
Sponsor
First posted
Sep 19, 2024
Start date
Oct 1, 2024
Primary completion
Jun 30, 2025 (estimated)
Completion
Jul 31, 2025 (estimated)
Last update
Mar 24, 2025

Study contacts

Aqsa Liqat, DPT
Contact
aqsa.liaqat@riphah.edu.pk
00923365917386
Mirza Obaid Baig, MSPT
Contact
obaid.baig@riphah.edu.pk
00923332238706
Mirza Obaid Baig, MSPT
principal investigator · Riphah International University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion