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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12-16 minutes after the stimulation contrasting baseline (before stimulation)
Awards & highlights
Study Summary
This trial aims to better understand how HD-tDCS affects the brain to improve medical treatment.
Who is the study for?
This trial is open to individuals who have experienced electrocution but do not have any neurological or psychiatric diseases, especially seizures. Participants should not have metal implants, cardiac pacemakers, and must not be pregnant or breastfeeding. An abnormal MRI also disqualifies someone from participating.Check my eligibility
What is being tested?
The study is examining the effects of a brain stimulation technique called high definition transcranial direct current stimulation (HD-tDCS) on neural connectivity to improve its clinical applications.See study design
What are the potential side effects?
Potential side effects of HD-tDCS may include discomfort at the electrode site, itching, tingling sensations during application, headache, fatigue, nausea or dizziness.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12-16 minutes after the stimulation contrasting baseline (before stimulation)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12-16 minutes after the stimulation contrasting baseline (before stimulation)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
change of functional connectivity
Secondary outcome measures
Toronto Mindfulness Scale (curiosity)
Toronto Mindfulness Scale (decentering)
change of cerebral blood flow
Trial Design
5Treatment groups
Experimental Treatment
Placebo Group
Group I: right DLPFC stimulationExperimental Treatment1 Intervention
HD-tDCS will be used to deliver direct current to the target via rubber electrodes and HD-tDCS gels. The 9 electrodes (8 channels + 1 ground) positions and current intensity will be determined based on computer simulation using HDTargets software (Soterix Inc.) that results in maximum focal current on the right dorsolateral prefrontal cortex (DLPFC; x=+42, y=+14, z=+30) with inward field orientation. The peak current will not exceed 2 mA. A constant current will be delivered for 20 minutes.
Group II: left IPL stimulationExperimental Treatment1 Intervention
HD-tDCS will be used to deliver direct current to the target via rubber electrodes and HD-tDCS gels. The 9 electrodes (8 channels + 1 ground) positions and current intensity will be determined based on computer simulation using HDTargets software (Soterix Inc.) that results in maximum focal current on the left intraparietal lobe (IPL; x=-50, y=-36, z=+42) with inward field orientation. The peak current will not exceed 2 mA. A constant current will be delivered for 20 minutes.
Group III: left DLPFC stimulationExperimental Treatment1 Intervention
HD-tDCS will be used to deliver direct current to the target via rubber electrodes and HD-tDCS gels. The 9 electrodes (8 channels + 1 ground) positions and current intensity will be determined based on computer simulation using HDTargets software (Soterix Inc.) that results in maximum focal current on the left dorsolateral prefrontal cortex (DLPFC; x=-44, y=10, z=30) with inward field orientation. The peak current will not exceed 2 mA. A constant current will be delivered for 20 minutes.
Group IV: VLPFC-PCC stimulationExperimental Treatment1 Intervention
HD-tDCS will be used to deliver direct current to the target via rubber electrodes and HD-tDCS gels. The 9 electrodes (8 channels + 1 ground) positions and current intensity will be determined based on computer simulation using HDTargets software (Soterix Inc.) that results in maximum focal current on the left ventrolateral prefrontal cortex (VLPFC; x=-50, y=+26, z=+8) and posterior cingulate cortex (PCC; x=1, y=-61, z=38) with inward field orientation. The peak current will not exceed 2 mA. A constant current will be delivered for 20 minutes.
Group V: Sham stimulationPlacebo Group1 Intervention
One of the above three targets will be randomly selected. The current will be applied for 30 seconds ramp-up followed by 30 seconds ramp-down.
Find a Location
Who is running the clinical trial?
University of ManitobaLead Sponsor
595 Previous Clinical Trials
199,381 Total Patients Enrolled
Natural Sciences and Engineering Research Council, CanadaOTHER
58 Previous Clinical Trials
3,001 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of or am at risk for neurological or psychiatric diseases, especially seizures.
Research Study Groups:
This trial has the following groups:- Group 1: Sham stimulation
- Group 2: VLPFC-PCC stimulation
- Group 3: right DLPFC stimulation
- Group 4: left IPL stimulation
- Group 5: left DLPFC stimulation
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals can participate in this medical trial?
"Affirmative. Clinicaltrials.gov states that this clinical experiment, which was initially shared on July 1st 2023 is currently recruiting patients. The trial needs to recruit around 100 subjects from one site of study."
Answered by AI
Are participants being accepted into this experiment at the present time?
"Affirmative. On clinicaltrials.gov, the information indicates that this medical trial is actively enrollment participants. It was initially listed on July 1st 2023 and last edited on July 17th 2023. One hundred subjects are being accepted at a single location for participation in the study."
Answered by AI
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