Dual-tDCS and Anodal PMC tDCS Over the Contralesional Hemisphere on the Upper Limb Function in Stroke Patients

NCT05180929 | Completed DMC FDA Device

• 1 other identifier: IAU
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Transcranial direct current stimulation (tDCS) has been gaining increasing interest as a potential therapeutic tool to improve upper extremity (UE) rehabilitation outcomes following stroke. Within the concept of interhemispheric inhibition (IHI), most tDCS studies have applied anodal ipsilesional and/or cathodal contralesional primary motor cortex (M1) tDCS to rebalance IHI and enhance motor recovery. However, compelling evidence suggests that an excitation/inhibition model is oversimplified, and the role of both hemispheres in the encoding of information during motor learning should be acknowledged. Moreover, multiple lines of evidence have demonstrated the potential relevance of contralesional premotor cortex (PMC) for recovery after M1 injury. Objective: We are aiming to investigate and compare the effects of two tDCS montages at different cortical sites (Dual-M1 vs. a-tDCS over contralesional PMC) by measuring the clinical outcomes of the most affected UE in patients with chronic subcortical stroke. Methods: 35 participants will be randomly assigned to 1 of 3 groups (Group A received dual- M1 tDCS, Group B received a-tDCS over contralesional PMC, and Group C received sham stimulation). tDCS will be applied using intensity of 2 mA for 20 min. (5 times/week) for 2 consecutive weeks. Fugl-Meyer Assessment of the Upper Extremity (FMA-UE) and Action Research Arm Test (ARAT) will be used to quantify the UE functional motor ability. Box and Block Test (BBT) will be used for gross manual dexterity and Nine Hole Peg Test (NHPT) will be used to measure fine hand dexterity. All measurements will be taken pre-treatment (T0) and post-treatment (T1) immediately after the 10th session, then 4 weeks after the end of stimulation period (T2) to assess the long-term effects. Expected results: This study would verify whether enhancing the motor cortical hyperexcitability in the contralesional hemisphere has a beneficial on recovery of the paretic hand, or regaining the balance of transcallosal inhibitory circuits between the motor areas in both hemispheres has more positive effects on the motor outcomes . This study would also provide a predictive approach to enable realistic rehabilitation goal-setting by identifying the proper tDCS montage for patients with stroke depending on their impairment level.

Conditions

Stroke

Keywords

tDCS; PMC; IHI; Stroke

Outcome Measures

Primary Outcomes (1)

• Change from Baseline 'Fugl-Meyer Assessment of the Upper Extremity (FMA-UE)' at 4 weeks

  the most frequently used outcome measure when assessing UE function after stroke within the research context (Santisteban et al., 2016). We will exclude the 3 reflex items because they make no difference to the overall scores of the test (Gladstone, Danells and Black, 2002; Woodbury et al., 2007; Woytowicz et al., 2017). It is composed of 30 items, each scored on a scale of 0 to 2. It has an excellent overall reliability (Duncan, Propst and Nelson, 1983; Sanford et al., 1993), validity and responsiveness as an indicator of motor impairment severity across different stroke recovery time points (Platz et al., 2005; Hsieh et al., 2009).

  T0: Baseline measurements (immediately prior stimulation), T1: Post-stimulation measurements (2 weeks after T0), T2: 4 weeks after T1 to evaluate the long-term effects

Secondary Outcomes (3)

• Change from Baseline 'Action Research Arm Test (ARAT)' at 4 weeks

  T0: Baseline measurements (immediately prior stimulation), T1: Post-stimulation measurements (2 weeks after T0), T2: 4 weeks after T1 to evaluate the long-term effects

• Change from Baseline 'Box and Block Test (BBT)' at 4 weeks

  T0: Baseline measurements (immediately prior stimulation), T1: Post-stimulation measurements (2 weeks after T0), T2: 4 weeks after T1 to evaluate the long-term effects

• Change from Baseline 'Nine Hole Peg Test (NHPT)' at 4 weeks

  T0: Baseline measurements (immediately prior stimulation), T1: Post-stimulation measurements (2 weeks after T0), T2: 4 weeks after T1 to evaluate the long-term effects

Study Arms (3)

Dual-M1 tDCS

EXPERIMENTAL

In the M1- dual tDCS montage, the anodal electrode will be placed above ipsilesional M1 and the cathode will be positioned over contralesional M1.

Device: Dual M1-tDCS

a-tDCS over contralesional PMC

EXPERIMENTAL

In the anodal-tDCS for PMC, the anodal electrode will be placed over the contralesional PMC. The PMC is defined as being 2.5 cm anterior to the M1. The cathodal electrode will be positioned over the contralateral suborbital region

Device: a-tDCS over contralesional PMC

Sham tDCS

SHAM COMPARATOR

For sham stimulation, there is no particular electrode configuration to be followed, thus, 6 participants will receive sham stimulation with the configuration will be used in group A, and 5 participants will receive sham stimulation with the configuration will be used in group B. By pressing the sham button, the current will automatically ramped up over 10 sec. till reaching 1 mA, then it will be decreased gradually over 30 seconds till turning off the apparatus. This is to ensure the typical initial itching sensation

Device: Sham tDCS

Interventions

Dual M1-tDCS DEVICE

In the M1- dual tDCS montage, the anodal electrode will be placed above ipsilesional M1 and the cathode will be positioned over contralesional M1.

Dual-M1 tDCS

a-tDCS over contralesional PMC DEVICE

In the anodal-tDCS for PMC, the anodal electrode will be placed over the contralesional PMC. The PMC is defined as being 2.5 cm anterior to the M1. The cathodal electrode will be positioned over the contralateral suborbital region

a-tDCS over contralesional PMC

Sham tDCS DEVICE

For sham stimulation, there is no particular electrode configuration to be followed, thus, 6 participants will receive sham stimulation with the configuration will be used in group A, and 5 participants will receive sham stimulation with the configuration will be used in group B. By pressing the sham button, the current will automatically ramped up over 10 sec. till reaching 1 mA, then it will be decreased gradually over 30 seconds till turning off the apparatus. This is to ensure the typical initial itching sensation

Sham tDCS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• First ever, unilateral, ischemic, subcortical stroke in the territories supplied by the Middle Cerebral Artery (MCA) verified by brain imaging, at chronic stage (≥ 6 months).
• Upper Extremity impairment verified by Fugl-Meyer Assessment-Upper Extremity (FMA-UE)
• Mini Mental State Examination Score ≥ 24

You may not qualify if:

• History of epileptic seizures.
• Pre-stroke motor impairment(s) affecting UE.
• Presence of UE contractures or deformities.
• Botulinum toxin to UE muscles in the last 6 months.
• Presence of damaged skin on the scalp that would interfere with tDCS stimulation.
• Individuals with metallic implant in the brain or medical devices (i.e., cardiac pacemaker, deep brain stimulator, cochlear implants).
• Use of CNS-affecting drugs.
• Additional neurological or psychiatric problem.
• Pregnancy.

Sponsors & Collaborators

• Turki Abualait: lead

Study Sites (1)

BrainStim Lab, Imam Abdulrahman Bin Faisal University

Dammam, Eastern Province, 32210, Saudi Arabia

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chair of Physical Therapy Department, Assistant Professor of Cognitive Neuroscience and Neurorehabilitation

Study Record Dates

• First Submitted: November 16, 2021
• First Posted: January 6, 2022
• Study Start: November 10, 2017
• Primary Completion: March 10, 2020
• Study Completion: March 14, 2020
• Last Updated: January 6, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)