- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04672122
The Effects of Cathodal tDCS on Muscle Strength in Healthy Adults
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation technique that can modulate cortical excitability. In 2000, Nitsche and Paulus reported the polarity-dependent effect of tDCS in humans, i.e., anodal tDCS facilitates cortical excitability while cathodal tDCS decreases it. (Nitsche & Paulus, 2000). TDCS studies have been replicated by many researchers and reported similar effects of tDCS in humans when using anodal and cathodal tDCS with an intensity of 1 mA. The linear effect of tDCS also has been reported by various studies, i.e., when increase intensity, the polarity-dependent effect of tDCS also enhances. However, conflicting results of cathodal tDCS efficacy have been reported.
Cortical excitability has been used to represent the efficacy of tDCS on neuroplasticity. The linear effect of cathodal tDCS on cortical excitability have been reported by researchers when using intensities at 1, 2, and 3 mA stimulated at the primary motor cortex in healthy participants (Batsikadze et al., 2013; Jamil et al., 2017; Kuo et al., 2013; Mosayebi Samani et al., 2019; Nitsche et al., 2003). Nevertheless, some studies showed the non-linear effects of cathodal tDCS (i.e., when increases intensity, cathodal tDCS enhances the cortical excitability) when using intensities at 1.5 and 2 mA in healthy participants (Batsikadze et al., 2013; Jamil et al., 2017; Mosayebi Samani et al., 2019). Hence, cathodal tDCS efficacy on cortical excitability is still controversy.
Muscle performance is an outcome that represents clinical change induced by tDCS. Previous studies reported the tendency of cathodal tDCS efficacy in decreasing muscle performance of both upper and lower extremities in healthy participants (Cogiamanian et al., 2007; Tanaka et al., 2009). However, previous studies used a single intensity of tDCS in each study. Hence, there was no direct comparison between different intensities of cathodal tDCS on muscle performance in healthy participants.
In our study, we aim to investigate the effect of different intensities of cathodal tDCS on muscle strength in healthy participants.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Nakhon Pathom
-
Salaya, Nakhon Pathom, Thailand, 73170
- Faculty of Physical Therapy, Mahidol University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Male and female healthy adults
- Age range between 18 - 60 years old
- Right-handed dominant identified by the Edinburg Handedness Inventory
- No recent muscle injuries of both limbs for a past 6-months
Exclusion Criteria:
- Consumed caffeine within 24 hours prior the experiment
- History of neurological symptoms i.e. seizures, weakness, loss of sensation or unclear history of pass illness
- Presence of metal implantation, intracranial shunt, cochlear implantation or cardiac pacemakers
- Presence of opened wound or infectious wound around scalp
- Presence of pain in evaluating muscle groups
- History of surgery in evaluating limbs
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Sham Comparator: Sham tDCS
Sham transcranial direct current stimulation (tDCS) will be applied for 20 mins.
Cathode on the primary motor area (M1) and Anode on the supraorbital area of contralateral side.
Current intensity will be at 2 mA (sham mode).
The scope of intervention is to investigate effect of sham tDCS on muscle strength.
|
Cathodal tDCS will be applied for 20 mins.
|
Experimental: Cathodal-tDCS 1 mA
Cathodal transcranial direct current stimulation (tDCS) will be applied for 20 mins.
Cathode on the primary motor area (M1) and Anode on the supraorbital area of contralateral side.
Current intensity is fixed at 1 mA and current will flow continuously.
The scope of intervention is to investigate effect of cathodal tDCS on muscle strength.
|
Cathodal tDCS will be applied for 20 mins.
|
Experimental: Cathodal-tDCS 1.5 mA
Cathodal transcranial direct current stimulation (tDCS) will be applied for 20 mins.
Cathode on the primary motor area (M1) and Anode on the supraorbital area of contralateral side.
Current intensity is fixed at 1.5 mA and current will flow continuously.
The scope of intervention is to investigate effect of cathodal tDCS on muscle strength.
|
Cathodal tDCS will be applied for 20 mins.
|
Experimental: Cathodal-tDCS 2 mA
Cathodal transcranial direct current stimulation (tDCS) will be applied for 20 mins.
Cathode on the primary motor area (M1) and Anode on the supraorbital area of contralateral side.
Current intensity is fixed at 2 mA and current will flow continuously.
The scope of intervention is to investigate effect of cathodal tDCS on muscle strength.
|
Cathodal tDCS will be applied for 20 mins.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline muscle strength after tDCS
Time Frame: Baseline (Pretest) and 40 minutes ( posttest)
|
Muscle strength will be measured in Newton by using a hand-held dynamometer.
|
Baseline (Pretest) and 40 minutes ( posttest)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- MU-CIRB2020/314.0210
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Healthy Participants
-
PfizerRecruitingHealthy Subjects | Healthy ParticipantsUnited States
-
PfizerRecruitingHealthy ParticipantsUnited States
-
PfizerNot yet recruiting
-
Aeovian Pharmaceuticals, Inc.RecruitingHealthy ParticipantsAustralia
-
Suzhou Zelgen Biopharmaceuticals Co.,LtdRecruitingHealthy ParticipantsChina
-
CelgeneRecruitingHealthy ParticipantsUnited States
-
Bristol-Myers SquibbRecruiting
-
AstraZenecaParexelRecruiting
-
ProMis Neurosciences, IncRecruiting
-
Novo Nordisk A/SRecruiting
Clinical Trials on Transcranial direct current stimulation
-
Medical University of South CarolinaEunice Kennedy Shriver National Institute of Child Health and Human Development...Recruiting
-
Federal University of ParaíbaCompleted
-
University of Campinas, BrazilUnknownEpilepsy IntractableBrazil
-
Dina Hatem ElhammadyUnknown
-
Shirley Ryan AbilityLabNational Institute on Deafness and Other Communication Disorders (NIDCD)CompletedStroke | Nonfluent AphasiaUnited States
-
University of Texas Rio Grande ValleyRecruitingSpinal Cord Diseases | Spinal Cord InjuriesUnited States
-
Federal University of ParaíbaUnknown
-
Riphah International UniversityRecruiting
-
Universidade Federal do Rio Grande do NorteNot yet recruitingLow Back Pain | Transcranial Direct Current Stimulation
-
University of CalgaryAlberta Health servicesCompletedCervicogenic HeadacheCanada