Cognitive Training and Brain Stimulation in Prodromal Alzheimer's Disease

Mild Cognitive Impairment Clinical Trial

— AD-Stim  

Official title:

Effects of Cognitive Training and Brain Stimulation in Prodromal Alzheimer's Disease - Randomised, Sham Controlled, Interventional Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04265378
• Other study ID #: AD-Stim
• Status: Completed
• Phase: N/A
• Start date: May 1, 2019
• Est. completion date: October 10, 2022

Study information

• Verified date: November 2022
• Source: University Medicine Greifswald
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to investigate whether a tDCS-accompanied intensive cognitive training of working memory leads to performance improvement in individuals with prodromal Alzheimer's disease.

Description:

The goal of the present study is to assess behavioral (primary) effects of a multi-session cognitive training combined with transcranial direct current stimulation (tDCS). Many studies to date have found tDCS to be an efficient method to enhance various cognitive functions by modulating cortical excitability in young adults, but its behavioral impact and underlying mechanisms in pathological aging still need to be elucidated. Individuals with prodromal Alzheimer's disease, will participate in a three-week cognitive training with concurrent online tDCS application. Cognitive performance (primary) will be examined before, during and after the intervention, in order to draw conclusions about the effect of tDCS. In addition to cognitive training, a control group, receiving sham stimulation during training, will be assessed. Follow-up sessions to assess long-term effects are planned four weeks and seven months after the post assessment. Furthermore, to assess potential predictors of tDCS effects, functional and structural parameters will be measured with MRI. The results of the study will offer valuable insights into efficacy of combined tDCS and cognitive training, as compared to training alone, in individuals with prodromal stages of Alzheimer's disease. Moreover, improved understanding of tDCS effects on cognitive training performance and underlying neural correlates may help to develop novel approaches for modulating cognitive decline in healthy and pathological aging.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: October 10, 2022
• Est. primary completion date: October 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 80 Years

Eligibility

Inclusion Criteria:

• Older adults (60 - 80 years);
• Right handedness;
• subjective cognitive decline (SCD) or mild cognitive impairment (MCI)

Exclusion Criteria:

• Dementia or other neurodegenerative neurological disorders; epilepsy or history of seizures; close relatives with epilepsy or history of seizures; previous stroke;
• Severe and untreated medical conditions that precludes participation in the training, as determined by responsible physician;
• History of severe alcoholism or use of drugs;
• Severe psychiatric disorders such as depression (if not in remission) or psychosis

Related Conditions & MeSH terms

• Alzheimer Disease
• Cognitive Dysfunction
• Mild Cognitive Impairment
• Subjective Cognitive Decline

Intervention

Device:
• anodal tDCS
Anodal transcranial direct current stimulation (tDCS), 9 sessions with 20 minutes stimulation each (current intensity of 1mA)

Behavioral:
• Intensive cognitive training
Intensive cognitive training of a letter memory updating task and a 3-stage Markov decision making task, 9 sessions

Locations

Country	Name	City	State
Germany	University Medicine Greifswald	Greifswald

Sponsors (1)

Lead Sponsor	Collaborator
University Medicine Greifswald

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Working memory training performance (Letter Updating task)	Performance in a memory training task (Letter updating) under anodal tDCS compared to sham condition; operationalized by working Memory Updating performance assessed with number of correctly recalled letter lists in the letter updating task, analyzed immediately after training period (anodal condition versus sham)	3 weeks
Secondary	Working memory training performance (Markov task)	Performance in second memory training task (Markov decision making) under anodal tDCS compared to sham condition, analyzed immediately after training period (anodal condition versus sham)	3 weeks
Secondary	Transfer outcomes: numerical n-back task (% correct)	Comparing performance immediately before and after training period (anodal condition versus sham)	3 weeks
Secondary	Transfer outcomes: AVLT (auditory verbal learning test) (sum of correctly recalled items trials 1-5)	Comparing performance immediately before and after training period (anodal condition versus sham)	3 weeks
Secondary	Transfer outcomes: Wiener Matrices Test (no. correct)	Comparing performance immediately before and after training period (anodal condition versus sham)	3 weeks
Secondary	Long-term outcomes: Letter Updating task (no. of correctly recalled lists)	Comparing performance immediately before and after training period with performance at 4 weeks and 7-months after training period (anodal condition versus sham)	4 weeks and 7 months after training
Secondary	Long-term outcomes: Markov decision making task (% optimal actions)	Comparing performance immediately before and after training period with performance at 4 weeks and 7-months after training period (anodal condition versus sham)	4 weeks and 7 months after training
Secondary	Long-term outcomes: numerical n-back task (% correct)	Comparing performance immediately before and after training period with performance at 4 weeks and 7-months after training period (anodal condition versus sham)	4 weeks and 7 months after training
Secondary	Long-term outcomes: AVLT (auditory verbal learning test) (sum of correctly recalled items trials 1-5)	Comparing performance immediately before and after training period with performance at 4 weeks and 7-months after training period (anodal condition versus sham)	4 weeks and 7 months after training
Secondary	Long-term outcomes: Wiener Matrices Test (no. correct)	Comparing performance immediately before and after training period with performance at 4 weeks and 7-months after training period (anodal condition versus sham)	4 weeks and 7 months after training
Secondary	Neural correlates: Structural neural correlates of tDCS effect	- structural neural correlates; assessed by grey matter volumes, cortical thickness, white matter microstructure (diffusion tensor imaging (DTI) measures: fractional anisotropy, mean diffusivity); before the intervention and at 7-months after training period (correlations in anodal group)	before training; 7 months after training
Secondary	Neural correlates: Functional neural correlates of tDCS effect	- functional neural correlates; assessed by resting-state fMRI analyses to obtain functional connectivities (seed-based connectivity: correlation of BOLD-timeseries between a seed/ROI and every voxel/location in the brain); before the intervention and at 7-months after training period (correlations in anodal group)	before training; 7 months after training