Clinical trial NCT03049969: Cognitive Remediation Augmented With Transcranial Direct Current Stimulation (tDCS)
Official title: Cognitive Remediation Augmented With Transcranial Direct Current Stimulation (tDCS)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Multiple Sclerosis
Neurological Disorder
Keywords: Working Memory
Cognitive Training
Transcranial Magnetic Stimulation
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2017-02-10
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 20 sessions of cognitive remediation while receiving 20 minutes of up to 2.0 mA tDCS using a DLPFC montage
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants Completing at Least 80% of the Targeted Number of Sessions.
timeFrame: End of treatment (up to 12 weeks)
measure: Number of Participants With Treatment Related Adverse Events
timeFrame: End of treatment (up to 12 weeks)
Secondary outcomes:
measure: Change in Visual Analogue Scale (VAS) for Pain Score
timeFrame: Baseline, end of treatment (up to 12 weeks)
measure: Change in Negative Affect Score From the Positive and Negative Affect Scale (PANAS)
timeFrame: Baseline, end of treatment (up to 12 weeks)
measure: Change in Positive Affect Score From the Positive and Negative Affect Scale (PANAS)
timeFrame: Baseline, end of treatment (up to 12 weeks)
measure: Change in Symbol Digit Modalities Test (SDMT) Score
timeFrame: Baseline, end of treatment (up to 12 weeks)
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University Medical Center
state: New York
Study officials:
affiliation: New York University Medical Center Institutional Review Boards
name: Leigh Charvet, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pilloni G, Shaw M, Feinberg C, Clayton A, Palmeri M, Datta A, Charvet LE. Long term at-home treatment with transcranial direct current stimulation (tDCS) improves symptoms of cerebellar ataxia: a case report. J Neuroeng Rehabil. 2019 Mar 19;16(1):41. doi: 10.1186/s12984-019-0514-z.