Healthy ParticipantsNCT04672122
The Effects of Cathodal tDCS on Muscle Strength in Healthy Adults
A study testing Transcranial direct current stimulation in people with Healthy Participants, run by Mahidol University at 1 site in Thailand.
Trial summary
To investigate the effects of different intensity of cathodal tDCS on muscle strength in healthy adults. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- Transcranial direct current stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteThailand
- Study dates
- 16 Nov 2020to 31 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Faculty of Physical Therapy, Mahidol University
Salaya, Changwat Nakhon Pathom, 73170
About this study
To investigate the effects of different intensity of cathodal tDCS on muscle strength in healthy adults.
Read the 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.
- Conditions
- Healthy Participants
- Being tested
- Transcranial direct current stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial direct current stimulationDevice
Cathodal tDCS will be applied for 20 mins.
| Study group | Role | What they receive |
|---|---|---|
| Sham tDCS | Sham comparator | 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. Receives: Device: Transcranial direct current stimulation |
| Cathodal-tDCS 1 mA | Experimental | 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. Receives: Device: Transcranial direct current stimulation |
| Cathodal-tDCS 1.5 mA | Experimental | 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. Receives: Device: Transcranial direct current stimulation |
| Cathodal-tDCS 2 mA | Experimental | 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. Receives: Device: Transcranial direct current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline muscle strength after tDCS
Muscle strength will be measured in Newton by using a hand-held dynamometer.
Measured: Baseline (Pretest) and 40 minutes ( posttest)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start16 Nov 2020
- Primary completion31 Mar 2022
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wanalee Klomjai, PhD, Study director, MU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04672122
- Sponsor's protocol ID
- MU-CIRB2020/314.0210
- Status last verified
- Jun 2022
- First submitted
- 9 Dec 2020
- Last updated
- 22 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vimolratana O, Lackmy-Vallee A, Aneksan B, Hiengkaew V, Klomjai W. Non-linear dose response effect of cathodal transcranial direct current stimulation on muscle strength in young healthy adults: a randomized controlled study. BMC Sports Sci Med Rehabil. 2023 Jan 30;15(1):10. doi: 10.1186/s13102-023-00621-7.
PubMed 36717894
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Cathodal tDCS on Muscle Strength in Healthy Adults
- ClinicalTrials.gov ID
- NCT04672122
- Acronym / sponsor ID
- MU-CIRB2020/314.0210
- Conditions
- Healthy Participants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 16 Nov 2020 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 17 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate the effects of different intensity of cathodal tDCS on muscle strength in healthy adults.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Sham tDCS | Sham comparator | Device: Transcranial direct current stimulationSham 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 1 mA | Experimental | Device: Transcranial direct current stimulationCathodal 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 1.5 mA | Experimental | Device: Transcranial direct current stimulationCathodal 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 2 mA | Experimental | Device: Transcranial direct current stimulationCathodal 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial direct current stimulationCathodal tDCS will be applied for 20 mins. | Device | Cathodal-tDCS 1 mA, Cathodal-tDCS 1.5 mA, Cathodal-tDCS 2 mA, Sham tDCS |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2022.
- Derived from this study: PubMed 36717894Vimolratana O, Lackmy-Vallee A, Aneksan B, Hiengkaew V, Klomjai W. Non-linear dose response effect of cathodal transcranial direct current stimulation on muscle strength in young healthy adults: a randomized controlled study. BMC Sports Sci Med Rehabil. 2023 Jan 30;15(1):10. doi: 10.1186/s13102-023-00621-7.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wanalee Klomjai, PhD study director
MU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial direct current stimulation in people with Healthy Participants, run by Mahidol University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline muscle strength after tDCS (time frame: Baseline (Pretest) and 40 minutes ( posttest)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04672122, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2022.