High definition transcranial direct current stimulation as an intervention for cognitive deficits in Alzheimer's dementia: A randomized controlled trial - 02/01/25

Doi : 10.1016/j.tjpad.2024.100023

Christian LoBue ^a,^b,^⁎ , Hsueh-Sheng Chiang ^c, Amber Salter ^c, Shawn McClintock ^a, Trung P. Nguyen ^c, Rebecca Logan ^c, Eric Smernoff ^d, Seema Pandya ^d, John Hart ^a,^c,^e
^a Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, TX, USA
^b Department of Neurological Surgery, University of Texas Southwestern Medical Center, Dallas, TX, USA
^c Department of Neurology, University of Texas Southwestern Medical Center, Dallas, TX, USA
^d AT&T Memory Center, Baylor University Medical Center, Dallas, TX, USA
^e School of Behavioral and Brain Sciences, University of Texas at Dallas, Dallas, TX, USA

^⁎Correspondence author at: 5323 Harry Hines Blvd., Dallas, TX 75390-9044.5323 Harry Hines Blvd.DallasTX75390-9044

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Abstract

Background

Recent disease-modifying treatments for Alzheimer's disease show promise to slow cognitive decline, but show no efficacy towards reducing symptoms already manifested.

Objectives

To investigate the efficacy of a novel noninvasive brain stimulation technique in modulating cognitive functioning in Alzheimer's dementia (AD).

Design

Pilot, randomized, double-blind, parallel, sham-controlled study

Setting

Clinical research site at UT Southwestern Medical Center

Participants

Twenty-five participants with clinical diagnoses of AD were enrolled from cognition specialty clinics.

Intervention

Treatment consisted of high definition transcranial direct current stimulation (HD-tDCS) delivered for 20 min over the medial prefrontal cortex. Ten sessions of sham, 1 mA, or 2 mA stimulation were received.

Measurements

Cognitive outcomes were measured at baseline, after the last HD-tDCS session, and 8-weeks post-treatment. The primary outcome was change in total learning and delayed recall on the Rey Auditory Verbal Learning Test (RAVLT) immediately post-treatment and at 8-weeks. Secondary outcomes included measures of language, processing speed, and executive functioning. A multi-stage approach was used to examine cognitive outcomes, which included evaluation of effect sizes, statistical effects, and rate of clinically meaningful responses.

Results

In this pilot trial, no statistically significant differences on cognitive outcomes were found between sham and active HD-tDCS immediately post-treatment (p's > 0.05). However, moderate-to-large effect sizes were identified for enhanced RAVLT total learning (Cohen's d = 0.69–0.93) and phonemic fluency (d = 1.08–1.49) for both active HD-tDCS conditions compared to sham, with rates of clinically relevant improvement between 25 and 33%. Meaningful enhancement persisted to 8 weeks only for the 1 mA condition.

Conclusions

Multiple sessions of HD-tDCS over the medial prefrontal cortex appears to have potential to produce meaningful cognitive enhancements in a proportion of patients having AD with improvements maintained for at least 8 weeks in some.

Trial Registration Information

ClinicalTrials.gov (NCT05270408). Registered December 30, 2021.

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Keywords : Neuropsychological tests, Neurodegenerative disorders, Alzheimer's disease, Transcranial electrical stimulation, Transcranial direct current stimulation