Noninvasive Brain Stimulation on Memory in Individuals With Mild Cognitive Impairment and History of Brain Injury
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|ClinicalTrials.gov Identifier: NCT04504630|
Recruitment Status : Recruiting
First Posted : August 7, 2020
Last Update Posted : December 10, 2020
|Condition or disease||Intervention/treatment||Phase|
|Amnestic Mild Cognitive Impairment Traumatic Brain Injury Mild Traumatic Brain Injury||Device: High Definition Transcranial Direct Current Stimulation Device: Sham HD-tDCS||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||High-Definition Transcranial Direct Current Stimulation on Episodic Memory in Individuals With Amnestic Mild Cognitive Impairment and History of TBI|
|Actual Study Start Date :||December 5, 2020|
|Estimated Primary Completion Date :||January 31, 2023|
|Estimated Study Completion Date :||August 31, 2023|
Active Comparator: Active HD-tDCS
Participants will receive 10 sessions of active stimulation (1 mA anodal HD-tDCS targeting dorsal anterior cingulate region for 20 minutes) across 2 weeks, with episodic memory tasks completed at baseline, immediate follow-up after session 10, and a 3-month follow-up.
Device: High Definition Transcranial Direct Current Stimulation
This wireless device delivers a very low electrical current to focused regions on the scalp in order to modulate underlying brain circuits to promote neuroplasticity. The device will be fitted onto a neoprene EEG cap, with 1 anode electrode placed and surrounded by 4 cathode electrodes in a ring pattern. Electrical stimulation will be applied using a constant voltage cortical stimulator (Model D185, Digitimer Ltd, UK, maximal output 1000 V/1.5 A) with single square-wave 50-μs pulses (0.1 A/μs rise time).
Sham Comparator: Sham HD-tDCS
Participants will receive 10 sessions of sham stimulation across 2 weeks, with episodic memory tasks completed at baseline, immediate follow-up after session 10, and a 3-month follow-up.
Device: Sham HD-tDCS
- Mean change from baseline in episodic memory functioning immediately following the last HD-tDCS session and at 3-month follow-up [ Time Frame: Baseline, immediately following last HD-tDCS session, and again at 3-month follow-up ]Episodic verbal memory will be assessed with the Hopkins Verbal Learning Test-Revised (HVLT-R). This measures rate of learning for verbal material and the amount retained after a delay. Episodic visual memory will be assessed with the Brief Visuospatial Memory Test-Revised (BVMT-R). This measures rate of learning for visual material and the amount retained after a delay. Both measures provide standardized scores based on a normative sample adjusted for key demographic factors, with higher scores reflecting better performances.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04504630