40 Participants Needed

Combination of tDCS and Cognitive Rehabilitation for Mild Cognitive Impairment and Late Life Depression

SO
Tarek Rajji | Department of Psychiatry
Overseen ByTarek Rajji, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Centre for Addiction and Mental Health
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

The overall goals of this project are to assess the feasibility and impact of designing and implementing an at-home intervention aimed at preventing long-term cognitive decline and improving cognition in individuals currently at-risk for developing AD.

Will I have to stop taking my current medications?

You may need to stop taking certain medications, especially anticonvulsants and some psychotropic drugs, unless they can be safely tapered off. However, some medications like zopiclone, trazodone, benzodiazepines, gabapentin, pregabalin, duloxetine, venlafaxine, or low-dose tricyclic antidepressants are allowed if you've been on a stable dose for at least 4 weeks before joining the study.

What data supports the effectiveness of this treatment for mild cognitive impairment and late life depression?

Research shows that transcranial direct current stimulation (tDCS), a method of gently stimulating the brain, can help improve cognitive function in people with mild cognitive impairment. Combining tDCS with cognitive rehabilitation, which involves exercises to improve thinking skills, has shown promise in enhancing cognitive abilities in conditions like Alzheimer's and stroke.12345

Is the combination of tDCS and cognitive rehabilitation safe for humans?

Transcranial direct current stimulation (tDCS) is generally considered safe and well-tolerated for use in humans, including those with mild cognitive impairment and other neurocognitive disorders.12356

How is the combination of tDCS and cognitive rehabilitation unique for treating mild cognitive impairment and late-life depression?

This treatment is unique because it combines transcranial direct current stimulation (tDCS), a non-invasive method that uses electrical currents to stimulate the brain, with cognitive rehabilitation exercises. This combination aims to enhance cognitive function more effectively than either approach alone, especially in individuals with lower baseline cognitive function.12789

Research Team

TR

Tarek Rajji, MD

Principal Investigator

Centre for Addiction and Mental Health

Eligibility Criteria

This trial is for people over 60 with mild cognitive impairment (MCI) or a history of depression. Participants must meet specific criteria, have had depression in the past decade but currently have low depressive symptoms, and be able to communicate in English. They need a study partner who knows them well. Those with schizophrenia, bipolar disorder, OCD, or recent substance abuse can't join.

Inclusion Criteria

Ability to read and communicate in English (with corrected vision and hearing, if needed)
Availability of a study partner who has regular contact with the participant
MADRS score of 10 or below
See 7 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive active cognitive remediation and transcranial Direct Current Stimulation (tDCS) at home for 8 weeks

8 weeks
5 sessions per week, at-home

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

Treatment Details

Interventions

  • Facilitate tDCS + CR
  • Receive tDCS+CR
Trial OverviewThe trial tests an at-home intervention combining transcranial direct current stimulation (tDCS) and cognitive rehabilitation (CR) to see if it can prevent worsening memory and thinking problems in those at risk for Alzheimer's disease.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Receive tDCS + CRExperimental Treatment1 Intervention
Receive tDCS+CR: Over the course of 8 weeks, for 5 days a week, participants designated a 'Patient' will receive active tDCS \&CR at-home. tDCS will be administered during the 2 hour CR sessions for 30 min/day. The tDCS montage will be bifrontal91 with 1 large anode placed over Fz and the cathode over Iz. The direct current will be 2 mA (current density = 0.57 A/m2). CR sessions will utilize didactic and computerized drill-based exercises which focus on practice and repetition of neurocognitive ability areas that are affected in depression such as attention, processing speed, executive function, verbal memory, and working memory. Performance feedback is given to reinforce progress and the exercises are designed to be enjoyable to complete, with titrated difficulty levels over time.
Group II: Facilitate tDCS + CRExperimental Treatment1 Intervention
Over the course of 8 weeks, for 5 days a week, participants designated a 'facilitator' will trained to deliver tDCS \&CR at-home. tDCS will be administered during the 2 hour CR sessions for 30 min/day. The tDCS montage will be bifrontal91 with 1 large anode placed over Fz and the cathode over Iz. The direct current will be 2 mA (current density = 0.57 A/m2). CR sessions will utilize didactic and computerized drill-based exercises which focus on practice and repetition of neurocognitive ability areas that are affected in depression such as attention, processing speed, executive function, verbal memory, and working memory.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Centre for Addiction and Mental Health

Lead Sponsor

Trials
388
Recruited
84,200+

CAMH Foundation

Collaborator

Trials
3
Recruited
910+

Findings from Research

Transcranial direct current stimulation (tDCS) is a safe and noninvasive method that shows promise in treating cognitive decline associated with Alzheimer's disease and mild cognitive impairment.
The review highlights the need for further large-scale clinical trials to better understand the mechanisms of tDCS and improve its application in clinical settings.
Potential of Transcranial Direct Current Stimulation in Alzheimer's Disease: Optimizing Trials Toward Clinical Use.Pilloni, G., Charvet, LE., Bikson, M., et al.[2022]
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.
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]
In a study involving 11 newly diagnosed stroke patients, the combination of transcranial direct current stimulation (tDCS) and computer-assisted cognitive rehabilitation (CACR) significantly improved cognitive function compared to a control group receiving sham stimulation.
Patients receiving tDCS showed notable enhancements in auditory and visual continuous performance tests, suggesting that targeting the prefrontal cortex with tDCS alongside cognitive training can effectively aid recovery from cognitive dysfunction after a stroke.
A double-blind, sham-controlled, pilot study to assess the effects of the concomitant use of transcranial direct current stimulation with the computer assisted cognitive rehabilitation to the prefrontal cortex on cognitive functions in patients with stroke.Park, SH., Koh, EJ., Choi, HY., et al.[2022]

References

Potential of Transcranial Direct Current Stimulation in Alzheimer's Disease: Optimizing Trials Toward Clinical Use. [2022]
The Effects of Transcranial Direct Current Stimulation on the Cognitive Functions in Older Adults with Mild Cognitive Impairment: A Pilot Study. [2022]
Effect of home-based transcranial direct current stimulation (tDCS) on cognitive function in patients with mild cognitive impairment: a study protocol for a randomized, double-blind, cross-over study. [2020]
A double-blind, sham-controlled, pilot study to assess the effects of the concomitant use of transcranial direct current stimulation with the computer assisted cognitive rehabilitation to the prefrontal cortex on cognitive functions in patients with stroke. [2022]
Effects of multisession transcranial direct current stimulation as an augmentation to cognitive tasks in patients with neurocognitive disorders in Japan: a study protocol for a randomised controlled trial. [2021]
Safety and Feasibility of Transcranial Direct Current Stimulation for Cognitive Rehabilitation in Patients With Mild or Major Neurocognitive Disorders: A Randomized Sham-Controlled Pilot Study. [2022]
Identifying factors influencing cognitive outcomes after anodal transcranial direct current stimulation in older adults with and without cognitive impairment: A systematic review. [2023]
Transcranial Direct Current Stimulation May Improve Cognitive-Motor Function in Functionally Limited Older Adults. [2019]
Behavioural and electrophysiological modulations induced by transcranial direct current stimulation in healthy elderly and Alzheimer's disease patients: A pilot study. [2020]