Cognitive FunctionsNCT06252480
Effect of Various Intensities of tDCS on Dual Task Cognitive Functions in Normal Subjects
A study testing tDCS in people with Cognitive Functions, run by Maharishi Markendeswar University (Deemed to be University) at 1 site in India.
Trial summary
Transcranial Direct Current Stimulation (tDCS) is a neuroregulatory method that delivers a weak straight tendency to neuronal areas with the intention of changing the brain's basic metabolic processes. Read more about this study
- Who is it for?
- Ages 18 to 26 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Functions
- What is being tested?
- tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteIndia
- Study dates
- 1 Aug 2023to 10 Mar 2024
- 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 26 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Physically healthy students only
- Willing to participate in the study
Who cannot join
- Any recent trauma or injury on the head of subjects
- If contact with the scalp is not possible
- Any resonant implant close to electrode placement site
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
MMIPR
Ambāla, Haryana, 133207
Subhashish Chatterjee, MPT(NEURO), +918950037407, subhasishphysio@gmail.com
Subhashish Chatterjee, MPT
About this study
Official title: Effect of Various Intensities of tDCS on Dual Task Cognitive Functions in Normal Subjects: A Pilot Study
Transcranial Direct Current Stimulation (tDCS) is a neuroregulatory method that delivers a weak straight tendency to neuronal areas with the intention of changing the brain's basic metabolic processes. Degradation of executive performance may not necessarily arise from cathodal stimulation, and vice versa for anodal stimulation.
Read the detailed description
Total 48 samples were taken, were randomly allocated into an experimental group of 4 variance of different intensities of tDCS. At F3 and F4, tDCS was applied to the desired region. Electrodes were put in using the 10-20 EEG technique throughout the parietal cortex, with the current electrode being set on F3 area and control electrode being positioned on the F4 area. For 20 minutes over three days per week for up to three weeks, current intensities of 0.5mA for group A, 1.0mA for group B, 1.5mA for group C, and 2.0mA for group D were administered. when engaging in dual-task cognitive processes. The groups are going to receive 9 sessions of tDCS treatment. The MoCA and TMT scale was completed by samples before and after the intervention. Finally, specifics investigation will be carried out using SPSS 26.0 software.
- Conditions
- Cognitive Functions
- Being tested
- tDCS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCSDevice
4 variance of different intensities of tDCS (0.5mA, 1 mA, 1.5mA and 2mA). At F3 and F4, tDCS was applied to the desired region. Electrodes were put in using the 10-20 EEG technique throughout the parietal cortex, with the current electrode being set on F3 area and control electrode being positioned on the F4 area. For 20 minutes over three days per week for up to three weeks, current intensities of 0.5mA for group A, 1.0mA for group B, 1.5mA for group C, and 2.0mA for group D were administered. when engaging in dual-task cognitive processes. The groups are going to receive 9 sessions of tDCS treatment.
| Study group | Role | What they receive |
|---|---|---|
| Intensities of tDCS and dual task cognitive functions | Experimental | We have done in a one arm type. The participants are divided into different intensity group (0.5 mA, 1.0 mA, 1.5 mA and 2.0 mA). Receives: Device: tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
MoCA
A quick test for minor cognitive impairment. It evaluates a variety of cognitive processes, including executive functioning, recall, speech and direction. The assessment has 30 points and requires 10 mins to finish for each person. A typical result is that 26 and more is normal.
Measured: 10 mins
Secondary outcomes (1)
TRAIL MAKING TEST
TMT part A includes 25 rounds containing the digits 1 to 25 scribbled haphazardly within every round on a sheet of paper. TMT part B similarly includes 25 rounds on a sheet of paper, but this rounds includes digits (1-12) and alphabet (A-L) instead of only being digits.
Measured: 3 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2024
- Study start1 Aug 2023
- Primary completion10 Feb 2024 (estimated)
- Study completion10 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive FunctionsStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maharishi Markendeswar University (Deemed to be University)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Subhasish Chatterjee, Maharishi Markendeswar University (Deemed to be University)
- Investigators
- Subhashish Chatterjee, MPT(NEURO), Principal investigator, Maharishi Markendeshwar Institute of Physiotherapy and Rehabilitation, Ambala, Haryana, 133207
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06252480
- Sponsor's protocol ID
- SPC-PA-07
- Status last verified
- Feb 2024
- First submitted
- 2 Feb 2024
- Last updated
- 9 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Various Intensities of tDCS on Dual Task Cognitive Functions in Normal Subjects: A Pilot Study
- ClinicalTrials.gov ID
- NCT06252480
- Acronym / sponsor ID
- SPC-PA-07
- Conditions
- Cognitive Functions
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Maharishi Markendeswar University (Deemed to be University)University, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 10 Feb 2024 (estimated)
- Study completion
- 10 Mar 2024 (estimated)
- First posted
- 9 Feb 2024 (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.
Transcranial Direct Current Stimulation (tDCS) is a neuroregulatory method that delivers a weak straight tendency to neuronal areas with the intention of changing the brain's basic metabolic processes. Degradation of executive performance may not necessarily arise from cathodal stimulation, and vice versa for anodal stimulation.
Detailed description
Total 48 samples were taken, were randomly allocated into an experimental group of 4 variance of different intensities of tDCS. At F3 and F4, tDCS was applied to the desired region. Electrodes were put in using the 10-20 EEG technique throughout the parietal cortex, with the current electrode being set on F3 area and control electrode being positioned on the F4 area. For 20 minutes over three days per week for up to three weeks, current intensities of 0.5mA for group A, 1.0mA for group B, 1.5mA for group C, and 2.0mA for group D were administered. when engaging in dual-task cognitive processes. The groups are going to receive 9 sessions of tDCS treatment. The MoCA and TMT scale was completed by samples before and after the intervention. Finally, specifics investigation will be carried out using SPSS 26.0 software.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intensities of tDCS and dual task cognitive functions | Experimental | Device: tDCSWe have done in a one arm type. The participants are divided into different intensity group (0.5 mA, 1.0 mA, 1.5 mA and 2.0 mA). |
Who may qualify
- Ages
- 18 to 26 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Physically healthy students only
- Willing to participate in the study
Key exclusion criteria (3 listed)
- Any recent trauma or injury on the head of subjects
- If contact with the scalp is not possible
- Any resonant implant close to electrode placement site
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 |
|---|---|---|
| tDCS4 variance of different intensities of tDCS (0.5mA, 1 mA, 1.5mA and 2mA). At F3 and F4, tDCS was applied to the desired region. Electrodes were put in using the 10-20 EEG technique throughout the parietal cortex, with the current electrode being set on F3 area and control electrode being positioned on the F4 area. For 20 minutes over three days per week for up to three weeks, current intensities of 0.5mA for group A, 1.0mA for group B, 1.5mA for group C, and 2.0mA for group D were administered. when engaging in dual-task cognitive processes. The groups are going to receive 9 sessions of tDCS treatment. | Device | Intensities of tDCS and dual task cognitive functions |
Primary outcome
MoCA
Time frame: 10 mins
A quick test for minor cognitive impairment. It evaluates a variety of cognitive processes, including executive functioning, recall, speech and direction. The assessment has 30 points and requires 10 mins to finish for each person. A typical result is that 26 and more is normal.
1 secondary outcome
TRAIL MAKING TEST
Time frame: 3 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2024.
- 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.
Subhashish Chatterjee, MPT(NEURO) principal investigator
Maharishi Markendeshwar Institute of Physiotherapy and Rehabilitation, Ambala, Haryana, 133207
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tDCS in people with Cognitive Functions, run by Maharishi Markendeswar University (Deemed to be University) at 1 site in India.
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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 9 Feb 2024. 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 India. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elina Osik, BPT (7629956147, elinaosik18@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MoCA (time frame: 10 mins). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Feb 2024.