Evaluation of a Cognitive Training Therapy Based on Synchronized Oscillatory Stimulation in Patients With Mild Cognitive Impairment Through a Randomized Clinical Trial
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Universidad del Desarrollo
- Enrollment
- 62
- Locations
- 2
- Primary Endpoint
- Prefrontal theta oscillation activity.
Study Overview
Brief Summary
The aging of the population has led to an increase in the prevalence of disabling and high-cost diseases, such as dementia and Mild Cognitive Impairment (MCI). The latter can be considered a prodromal phase of some dementias and a critical stage for interventions to postpone the impairment of functionality and thus maintain a better quality of life. A cognitive function to intervene in working memory (WM) since it represents the fundamental component of executive functions and is the gateway to maintaining long-term memory. This project proposes an intervention to enhance WM in these users, combining cognitive training with non-invasive brain stimulation, specifically transcranial electrical stimulation of alternating current (tACS). This proposal arises from recent evidence showing that it is possible to increase the capacity of WM in users with MCI through cognitive training. Along with this, tACS has been proposed as a specific neuronal plasticity inducer for the oscillatory pattern required for each mental process. WM is a process particularly susceptible to being enhanced by this technique, as the underlying electrophysiological oscillatory patterns of this process are well described. Thus, tACS would act as a potentiator of the residual capacity of WM in patients with neurodegenerative diseases.
This study is a phase II randomized, double-blind clinical trial with a 3-month follow-up. The study will be of 62 participants diagnosed with MCI over 60 years from Valparaíso, Chile. Participants will receive intervention that will combine 12 cognitive training sessions with non-invasive brain stimulation, specifically tACS. Depending on the intervention group to which they will be assigned, in 8 of these sessions, participants will receive either tACS or sham stimulation. Sessions will last approximately 1 hour and take place twice a week, over six weeks. The primary outcomes will be the electroencephalographic measurements, and the secondary effects will be cognitive assessments of WM. The outcomes will be performed before, immediately after, and three months after the end of the intervention.
The outcomes of this trial will add evidence about the benefits and feasibility of an intervention that combines cognitive training with non-invasive brain stimulation. The objective is to contribute tools for optimal cognitive treatment in patients with MCI. To enhance WM capacity, postpone the impairment of functionality, and obtain a better quality of life.
Detailed Description
Background At the global level, sociodemographic change is happening, characterized by progressive aging of the population and a modification of the epidemiological profile, with an increase in the prevalence of chronic diseases and other pathologies associated with aging, such as dementia. Dementia is an acquired and chronic pathology characterized by an impairment of brain functions involving cognitive, psychological, and behavioral symptoms. These symptoms affect people's ability to carry out their usual daily activities. These disabilities imply a challenge for the people themselves, their families, the state, and public policies.
To date, the therapeutic approach to patients with dementia has focused primarily on late-stage drug treatment. However, this type of intervention has reported good results on specific dimensions, and an efficacy questioned long-term. The use of drugs with non-pharmacological therapies has proposed that it would be more effective to complement the treatment of patients, and the efforts should be directed towards prevention. In this context, in prodromal phases of dementia, such as Mild Cognitive Impairment (MCI), it is suggested early interventions.
MCI refers to the intermediate stage between the cognitive changes observed by normal aging and those that occur due to dementia. Patients with MCI are especially likely to benefit from non-pharmacological intervention. Since these patients would maintain some degree of neuroplasticity, the patients would learn and apply new strategies to improve their cognitive functioning.
One critical component of cognitive skills affected in neurodegenerative diseases and dementias is working memory (WM). WM represents a fundamental pillar of cognitive functions and is the gateway to the maintenance of long-term memory. The traditional view assumes that the capacity of WM is a specific feature of each individual and that it is not modifiable. However, recent evidence has accumulated that the capacity of WM is susceptible to be enhanced by training. This improvement is related to enhanced activity, connectivity, and selectivity between the frontal and parietal cortex.
Despite these findings, most evidence comes from healthy populations with conserved neuroplasticity. This constitutes a problem for neurodegenerative diseases because it has been corroborated that neuroplasticity is limited in these pathologies. In this context, cognitive rehabilitation in these diseases must include therapeutic tools aimed at increasing neuroplasticity. The use of non-invasive brain stimulation offers an opportunity to increase the capacity of neuroplasticity in this population. However, there has not been a rehabilitation proposal that incorporates this technique into intervention programs. Advancements have been made in neuroscience on the mechanisms underlying WM that have not been incorporated into early intervention and cognitive training in subjects with MCI.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Care Provider)
Eligibility Criteria
- Ages
- 60 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age equal to or greater than 60 years.
- •Presence of Mild Cognitive Impairment, according to the diagnostic criteria established in Petersen et al. (2014).
- •Have six or more years of complete schooling (presence of reading and writing).
Exclusion Criteria
- •The previous diagnosis of other neurodegenerative diseases.
- •Attending another cognitive training program.
- •History of Epilepsy or current presence of epileptic seizures.
- •Presence of psychiatric diseases.
- •Presence of a relevant depressive picture (GDS >=2).
- •History of important neurological alterations such as the history of stroke, transient ischemic attack, cranial brain trauma.
- •Important alterations of communication.
Outcomes
Primary Outcomes
Prefrontal theta oscillation activity.
Time Frame: week 1 (pre-intervention), week 8 (1 week post intervention), week 20 (12 weeks post intervention)
The ratio of change of the normalized power (mean/standard error, micro Volt2 ) of prefrontal theta oscillation (5-10 Hz, Fz electrode) related to Successful Memory Performance. The prefrontal theta oscillation related to Successful Memory Performance (SMP) is calculated based on a single-trial general linear model that include SMP as the regressor of interest and Memory Load as a secondary regressor.
Secondary Outcomes
- Parietal theta oscillation activity.(week 1 (pre-intervention), week 8 (1 week post intervention), week 20 (12 weeks post intervention))
- Trail Making Test B (TMT-B). Chilean standard. (Arango-Lasprilla et al., 2015)(week 1 (pre-intervention), week 8 (1 week post intervention), week 20 (12 weeks post intervention))
- WAIS-IV Digit Retention subtest. Chilean standard. (Rosas et al., 2015)(week 1 (pre-intervention), week 8 (1 week post intervention), week 20 (12 weeks post intervention))
Investigators
Pablo Billeke
Social Neuroscience and Neuromodulation Laboratory Director
Universidad del Desarrollo