NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

Cognitive Remediation Augmented With Transcranial Direct Current Stimulation (tDCS)

TerminatedNA

Sponsor: NYU Langone Health

Conditions: Multiple Sclerosis, Neurological Disorder

Interventions: tDCS stimulation

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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.

Locations (1)

New York, New York, United States