Cognitive Remediation Augmented With Transcranial Direct Current Stimulation (tDCS)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- NYU Langone Health
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Number of Participants Completing at Least 80% of the Targeted Number of Sessions.
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Number of Participants Completing at Least 80% of the Targeted Number of Sessions.
Time Frame: End of treatment (up to 12 weeks)
The protocol is designed to have a decision-tree series of checkpoints that must be met in order to proceed at each step
Number of Participants With Treatment Related Adverse Events
Time Frame: End of treatment (up to 12 weeks)
Secondary Outcomes
- Change in Visual Analogue Scale (VAS) for Pain Score(Baseline, end of treatment (up to 12 weeks))
- Change in Negative Affect Score From the Positive and Negative Affect Scale (PANAS)(Baseline, end of treatment (up to 12 weeks))
- Change in Positive Affect Score From the Positive and Negative Affect Scale (PANAS)(Baseline, end of treatment (up to 12 weeks))
- Change in Symbol Digit Modalities Test (SDMT) Score(Baseline, end of treatment (up to 12 weeks))