Cognitive Remediation + tDCS for Mental Health Disorders in Seniors

(CREAtE Trial)

Overseen By Shima Ovaysikia, MA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Centre for Addiction and Mental Health

Disqualifiers: Active substance use, ECT, Cognitive impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 40

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how certain treatments can help seniors with mental health conditions live more independently. It involves cognitive remediation (CR), which uses exercises to enhance thinking skills like memory and attention, and transcranial direct current stimulation (tDCS), a non-invasive brain stimulation technique. Participants will be randomly assigned to receive either active tDCS or a placebo version during CR sessions. This trial suits seniors who have been stable with their mental health condition and have not needed recent hospitalization. If you can read a newspaper headline and hear a conversation, you might qualify. As an unphased trial, this study offers a unique opportunity to contribute to innovative research aimed at enhancing mental health treatments for seniors.

Do I need to stop my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, you must be clinically stable, which includes not having any changes in your psychotropic medication dosage within the 4 weeks before assessment.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that combining cognitive exercises (CR) with transcranial direct current stimulation (tDCS), a gentle brain stimulation technique, is generally safe and well-tolerated. In one study involving individuals with mild memory problems and recurring depression, this combination proved practical and raised no safety concerns. Another study confirmed the safety and tolerability of using tDCS to improve thinking skills.

While some studies did not find significant improvements in thinking skills with tDCS compared to a placebo, they reported no major safety issues. In fact, CR and tDCS have been shown to help slow memory and thinking problems in older adults with certain mental health conditions over time.

Overall, existing evidence suggests that CR and tDCS are safe for participants, with no major side effects reported in the reviewed studies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using Cognitive Remediation combined with Transcranial Direct Current Stimulation (tDCS) for mental health disorders in seniors because it offers a unique approach to enhancing cognitive function. Unlike traditional treatments that may rely on medication, this method combines targeted brain stimulation with strategic cognitive exercises to improve attention, memory, and learning. The direct current stimulation used in tDCS is thought to prime the brain for better learning and adaptation, potentially leading to faster and more sustainable cognitive improvements. Plus, the group setting encourages social interaction and support, which can be beneficial for seniors.

What evidence suggests that Cognitive Remediation and tDCS could be effective for mental health disorders in seniors?

This trial will compare two approaches: Cognitive Remediation combined with Active Transcranial Direct Current Stimulation (tDCS) and Cognitive Remediation with Sham tDCS. Research has shown that combining cognitive exercises with gentle electrical brain stimulation, like the active tDCS used in this trial, can slow memory and thinking problems in older adults. One study found that this combination improved mental abilities for up to six years in individuals over 72. It has been found to be safe and may assist those with mild memory issues or recurring depression. However, the level and duration of these improvements can vary among individuals. Overall, this treatment appears promising for helping seniors maintain their mental skills longer. ^{1 3 6 7 8}

Who Is on the Research Team?

Angela Golas, MD

Principal Investigator

Centre for Addiction and Mental Health

Are You a Good Fit for This Trial?

This trial is for seniors aged 50+ with mental health conditions who are stable, haven't been hospitalized for psychiatric reasons in the last 3 months, and haven't changed their psychotropic meds in the last month. They must be able to see, hear well enough to participate, speak English, and give informed consent.

Inclusion Criteria

Corrected visual ability that enables reading of newspaper headlines and corrected hearing capacity that is adequate to respond to a raised conversational voice.

Willingness to provide informed consent or assent as applicable.

Clinically stable as operationalized by (1) having not been admitted to a psychiatric hospital within the 3 months prior to assessment, (2) having had no change in psychotropic medication dosage within the 4 weeks prior to assessment, and (3) ascertained to be clinically and medically stable by one the study psychiatrists.

Exclusion Criteria

Has significant cognitive impairment that, in the opinion of the PI, precludes benefit from CR and therefore study participation.

I don't have skin diseases, pacemakers, metal in my head, brain devices, or conditions like epilepsy.

I have not had electroconvulsive therapy in the last 6 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo clinical, neuropsychological, and functional assessments before enrollment

1-2 weeks

Treatment

Participants receive Cognitive Remediation (CR) and tDCS for 8 weeks, 5 days per week

8 weeks

40 sessions (in-person)

Booster Sessions

Monthly booster sessions of CR and tDCS for 3-5 days each month

24-60 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, with annual assessments

24-60 months

What Are the Treatments Tested in This Trial?

Interventions

• Cognitive Remediation and Transcranial Direct Current Stimulation

Trial Overview

The study tests an 8-week daily cognitive remediation (CR) training with monthly boosters over up to five years. It also examines if brain stimulation using tDCS can enhance CR's effectiveness. Participants will be randomly assigned to active or sham (fake) tDCS groups.

How Is the Trial Designed?

Group I: Cognitive Remediation and Active Transcranial Direct Current Stimulation Active Control 1 Intervention

Cognitive Remediation (CR) is a form of group psychosocial intervention that uses a hybrid approach of restorative and strategy based methods to improve areas of cognition (ie. attention, memory, processing speed and learning) through the use of computerized exercises. Transcranial Direct Current Stimulation (tDCS): tDCS will be administered for 30 min/day, at the beginning of each group session. tDCS montage will be frontal with anode placed over Fz and the cathode over Iz. The direct current will be of 2 mA (current density = 0.57 A/m2). CR + tDCS is administered in groups consisting of 2-10 participants and one or two therapists. The groups meet 5 times per week for two hours per session over eight weeks, for a total of 40 sessions in induction phase. Afterwards 3 to 5 sessions per week on monthly boosters.

Group II: Cognitive Remediation and Sham Transcranial Direct Current Stimulation Placebo Group 1 Intervention

CR is identical to the one described under the Active Comparator Arm. However, sham tDCS will consist of active stimulation for only 1 min/day, at the beginning of each group session. tDCS montage and the frequency of the sessions and the boosters will be the same as for the Active Arm.

Who Is Running the Clinical Trial?

Centre for Addiction and Mental Health

Lead Sponsor

Trials

388

Recruited

84,200+

LOFT Community Services

Collaborator

LOFT Community Services

Collaborator

Trials

4

Recruited

490+

Published Research Related to This Trial

Transcranial Direct Current Stimulation (tDCS) has been shown to be safe, with no reports of Serious Adverse Effects or irreversible injuries across over 33,200 sessions involving more than 1,000 subjects, including vulnerable populations.

Safety assessments indicate that the current densities used in conventional tDCS (≤4 milliamperes) are significantly lower than those that could potentially cause brain injury, suggesting that tDCS protocols are well within safe limits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of Transcranial Direct Current Stimulation: Evidence Based Update 2016. Bikson, M., Grossman, P., Thomas, C., et al.[2022]

Transcranial direct current stimulation (tDCS) has shown potential to improve cognitive functions such as processing speed, working memory, and executive functions in patients with mood disorders and schizophrenia, based on a systematic review of 41 studies.

The effects of tDCS on cognitive functioning and memory in Alzheimer's disease and mild cognitive impairment are less clear, with evidence being inconclusive or weak, highlighting the need for standardized protocols in future research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial Direct Current Stimulation and Cognition in Neuropsychiatric Disorders: Systematic Review of the Evidence and Future Directions. Ciullo, V., Spalletta, G., Caltagirone, C., et al.[2022]

Transcranial direct current stimulation (tDCS) is a non-invasive technique that can influence neuronal activity and induce lasting synaptic changes, making it a promising treatment for neuropsychiatric disorders, particularly unipolar depression.

tDCS is advantageous due to its minimal side effects and potential for portability, which could allow for home use and enhance patient care in the future.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Non-invasive cortical stimulation: Transcranial direct current stimulation (tDCS). Sudbrack-Oliveira, P., Razza, LB., Brunoni, AR.[2022]

In a pilot study involving 30 older adults with depression and/or anxiety, transcranial direct current stimulation (tDCS) significantly improved executive functioning, particularly inhibitory processing and cognitive flexibility, as evidenced by better performance on the Stroop test and Trail Making Test-Part B.

The study suggests that tDCS may be a promising non-invasive treatment to enhance cognitive processing in geriatric patients, although it did not show significant effects on attention or working memory.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

tDCS over the left prefrontal Cortex improves mental flexibility and inhibition in geriatric inpatients with symptoms of depression or anxiety: A pilot randomized controlled trial. Figeys, M., Villarey, S., Leung, AWS., et al.[2022]

Anodal transcranial direct current stimulation (tDCS) significantly improved cognitive performance in healthy elderly individuals by increasing neural activity, as evidenced by enhanced P200 and P300 amplitudes during a working memory task.

Cathodal tDCS also showed potential benefits for Alzheimer's disease patients, increasing P200 amplitude and frontal theta activity, suggesting that tDCS can modulate neural function differently based on the individual's cognitive state.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioural and electrophysiological modulations induced by transcranial direct current stimulation in healthy elderly and Alzheimer's disease patients: A pilot study. Cespón, J., Rodella, C., Miniussi, C., et al.[2020]

Anodal transcranial direct current stimulation (tDCS) applied to the left dorsolateral prefrontal cortex significantly improved cognitive tasks related to processing speed, selective attention, and planning in five older adults with mild cognitive impairment (MCI).

The study suggests that combining tDCS with cognitive stimulation programs may enhance cognitive performance in individuals with MCI, but further research is needed to explore long-term effects and practical applications in daily life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effects of Transcranial Direct Current Stimulation on the Cognitive Functions in Older Adults with Mild Cognitive Impairment: A Pilot Study. Cruz Gonzalez, P., Fong, KNK., Brown, T.[2022]

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tDCS may improve cognitive functions in older adults with MCI, but inconsistencies persist in its magnitude and duration.

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According to the findings, CR and tDCS slowed cognitive decline in older adults with rMDD or MCI (month 60: 0.21; 95% CI, 0.07 to 0.35; ...

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