Cognitive Remediation Augmented With Transcranial Direct Current Stimu
Cognitive Remediation Augmented With Transcranial Direct Current Stimulation (tDCS)
What it found
The trial ended early for another reason (see below).
Reason given: New controlled trial was funded, this study was no longer needed.
What was tested
Treatment tested
- tDCS stimulation
Results by group
Number of Participants Completing at Least 80% of the Targeted Number of Sessions.
End of treatment (up to 12 weeks)
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Cognitive Remediation | 10 Participants | 15 |
Number of Participants With Treatment Related Adverse Events
End of treatment (up to 12 weeks)
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Cognitive Remediation | 14 Participants | 15 |
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| Cognitive Remediation | 15 | 0 (0.0%) | 0 |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
Number of Participants Completing at Least 80% of the Targeted Number of Sessions.
End of treatment (up to 12 weeks)
Number of Participants With Treatment Related Adverse Events
End of treatment (up to 12 weeks)
Safety
Other measures (4)
Change in Visual Analogue Scale (VAS) for Pain Score
Baseline, end of treatment (up to 12 weeks)
PainChange 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)
Thinking and memory
Who could take part
MS (type not specified) · 18 and over
Show the full 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.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Loading reviews and guidelines…
History
Started
Feb 2017
Main results due
Mar 2023
Finished
Mar 2023
Results posted
Jun 2024