|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
CTRI |
|
Last refreshed on:
|
26 June 2023 |
|
Main ID: |
CTRI/2017/07/009037 |
|
Date of registration:
|
13-07-2017 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Brain modulation with transcranial direct current stimulation (tDCS) for examining effect on cognitive functioning
|
|
Scientific title:
|
A pilot randomized controlled trial of targeted prefrontal cortex modulation with anodal transcranial direct current stimulation (tDCS) for examining task dependent effect on executive functioning |
|
Date of first enrolment:
|
16-07-2017 |
|
Target sample size:
|
36 |
|
Recruitment status: |
Open to Recruitment |
|
URL:
|
http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=19243 |
|
Study type:
|
Interventional |
|
Study design:
|
Randomized, Parallel Group, Placebo Controlled Trial Method of generating randomization sequence:Permuted block randomization, fixed Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Participant and Investigator Blinded
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
India
| | | | | | | |
|
Contacts
|
|
Name:
|
Rohit Verma
|
|
Address:
|
Department of Psychiatry, Room No. 4096, 4th Floor, Teaching Block, AIIMS, Ansari Nagar New Delhi
110029
South, DELHI
India |
|
Telephone:
|
9868005491 |
|
Email:
|
rohit.aiims@gmail.com |
|
Affiliation:
|
All India Institute of Medical Sciences |
|
|
Name:
|
Rohit Verma
|
|
Address:
|
Department of Psychiatry, Room No. 4096, 4th Floor, Teaching Block, AIIMS, Ansari Nagar New Delhi
110029
South, DELHI
India |
|
Telephone:
|
9868005491 |
|
Email:
|
rohit.aiims@gmail.com |
|
Affiliation:
|
All India Institute of Medical Sciences |
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria: 1. Right handed males of age 18-50 years.
2. Having passed at least 10th standard.
3. Those willing to give written informed consent.
Exclusion criteria: 1.History of chronic neurological, psychiatric or physical illness.
2.History of substance use disorder or history of substance intake (other than nicotine/caffeine) on the day prior to stimulation.
3.History of significant head trauma/ seizure.
4.Having implanted device or metals in brain/head or cardiac pacemaker.
5.Those using anti-depressants or any other psychoactive medications
Age minimum:
Age maximum:
Gender:
|
|
Health Condition(s) or Problem(s) studied
|
|
|
|
Intervention(s)
|
Intervention1: transcranial direct current stimulation (tDCS): tDCS is a pure neuromodulation technique: cathodal tDCS inhibits neuronal firing whereas anodal stimulation increases it. Two active tDCS stimulation in form of 1mA and 2mA will be provided in two different groups (12 participants in each group).
Control Intervention1: Sham tDCS: No stimulation will be provided by the electrodes kept over the participants head (12 participants).
|
|
Primary Outcome(s)
|
|
Stroop test scores for executive function evaluationTimepoint: Three visits separated by an interval by at least 48 hours
|
|
Secondary Outcome(s)
|
|
Side effect checklist for tDCSTimepoint: Three visits separated by an interval by at least 48 hours
|
|
Source(s) of Monetary Support
|
|
Non funded
|
|
Ethics review
|
Status: Approved
Approval date: 16/06/2017
Contact:
Institute Ethics Committee
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|