Cognitive Remediation Augmented With Transcranial Direct Current Stimulation (tDCS)

Study Overview
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Brief Summary
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The proposed study will test the feasibility and tolerability of transcranial direct current stimulation (tDCS) added to a cognitive remediation program in n=100 adults. For 60 cognitive remediation sessions, participants will receive 20 minutes of active tDCS stimulation (up to 4.0 mA, dorsolateral prefrontal cortex or montage dependent on specific area of deficit) while they complete the cognitive training tasks.

Detailed Description
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Transcranial Direct Current Stimulation (tDCS) is a novel, safe, well-tolerated, and low-cost treatment approach that may enhance the benefits of cognitive remediation. The application of tDCS is a relatively recent therapeutic development that utilizes low amplitude direct currents to induce changes in cortical excitability. To meet this study's objectives, investigators will focus specifically on working memory (WM) in both training and outcome. Limiting training to WM exercises will provide the opportunity to test proof of concept for the combined therapies within this shorter two-week time frame, and maximize the synergistic effect by engaging the same regions as targeted by the tDCS.

Official Title
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Cognitive Remediation Augmented With Transcranial Direct Current Stimulation (tDCS)

Conditions
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Multiple Sclerosis, Neurological Disorder

Intervention / Treatment
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* Device: tDCS stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least 18 years of age Clinician Referral for cognitive remediation. Have undergone a neurological examination and neuropsychological examination as part of standard of care. Has access to internet service at home compatible with the study laptop (Wi-Fi or ethernet cable) Able to commit to the designated period of study training sessions with baseline and follow-up visits. Able to understand the informed consent process and provide consent to participate in the study Exclusion Criteria: Visual, auditory and motor deficits that would prevent full ability to understand study instructions or operate the tDCS device or study laptop, as judged by treating clinician or study staff Primary, uncontrolled psychiatric disorder that would influence ability to participate Poorly controlled epilepsy Medical device implanted in the head (such as Deep Brain Stimulator) or in the neck (such as a Vagus Nerve Stimulator) Any skin disorder/sensitive skin (e.g., eczema, severe rashes), blisters, open wounds, burn including sunburns, cuts or irritation, or other skin defects which compromise the integrity of the skin at or near stimulation locations (where electrodes are placed) Treatment for a communicable skin disorder currently or over the past 12 months Other serious uncontrolled medical condition (e.g., cancer or acute myocardial infarction) Wide Range Achievement Test-4th Edition (WRAT-4) Reading Recognition score <85* Symbol Digit Modalities Test (SDMT) ≥3.0 SD below published norms* Learned English language after 12 years of age Pregnant or breastfeeding In the case of the potential participant having either speech, motor or vision impairment secondary to their condition that will limit the completion of the SDMT and WRAT-4 screening measures the substitutions as mentioned above will be used.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: 20 sessions of cognitive remediation while receiving 20 minutes of up to 2.0 mA tDCS using a DLPFC montage
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cognitive Remediation<br>For the 20 cognitive remediation sessions, eligible participants will receive 20 minutes of active tDCS stimulation (up to 2.0 mA, dorsolateral prefrontal cortex (dlPFC) motage) while they complete the cognitive training tasks. Once the participant has completed his/her 20 sessions a pre/post treatment assessment measures will be completed. | Device: tDCS stimulation<br>* up to 4.0 mA, dorsolateral prefrontal cortex (montage dependent on specific area of deficit) while completing cognitive training tasks<br>* Other names: Soterix Mini-CT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants completing at least 80% of the targeted number of sessions. | The protocol is designed to have a decision-tree series of checkpoints that must be met in order to proceed at each step | 1 Month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerability questionnaire | Administered by study staff (pre- and post-session) | 1 Month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Working Memory, Cognitive Training, Transcranial Magnetic Stimulation