tDCS as Treatment for Motor Function
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorBaycrest
About this trial
Previous preliminary results are sufficiently impressive to suggest that tDCS stimulation does have the potential to improve motor function when that ability is trained during stimulation. In the proposed study, the investigation will assess whether walking sessions combined with tDCS lead to improvements in motor function: gait, articulation, eye gaze, and motor dexterity. In addition, the investigators wish to examine if such results can be replicated in people with other conditions, such as cortical basal syndrome, and Parkinson's disease.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
3. Individuals with metal implants within the brain such as shunts will be excluded.
Trial design
Design model
Crossover
Treatments tested in this trial
Transcranial direct current stimulation (TDCS)
DeviceThe Crossover design will enable us to use each participant as their own control.
Stimulation Arm
DeviceParticipants will be exposed to the brain stimulation protocol while undergoing certain motor task during the training sessions.
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: Real tDCS Stimulation:Experimental treatment 1 intervention
Group B: Sham ArmPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Gait speed
Within each round, scores from the final week and final session of real tDCS stimulation will be compared to performance during the first week and final sham tDCS session to check for significant improvement. Our primary outcome measures will be those found for gait; for example, a faster walking time subsequent to tDCS stimulation compared to the placebo baseline. Participants will also return two weeks later for a post-stimulation evaluation to check if improvement was maintained. To check if the arrangement of electrodes impacts the effect, times from the final tDCS session of each round will be compared.
Time frame
Measures collected at three points each round: baseline in week 1, post-treatment at the final stimulation session, and follow-up two weeks after the final session.Secondary outcomes
1
Articulation Quality (Clinician-Rated Speech Production on Word and Sentence Repetition)
Articulation will be assessed using a clinician-administered repetition task involving single words and short sentences. Speech production quality will be rated by the clinician using a standardized 5-point articulation quality scale (1 = severely distorted, 5 = normal/near-normal production). The reported value will be the rating score.
Time frame
Measures collected at three points each round: baseline in week 1, post-treatment at the final stimulation session, and follow-up two weeks after the final session.2
Eye-Gaze Control (Clinician-Rated Ability to Track a Moving Target)
Eye-gaze performance will be evaluated using a bedside oculomotor task. Participants are asked to follow a moving pencil with their eyes while keeping their head still. A clinician will rate eye-gaze control on a standardized 3-point scale (0 = unable, 1 = inconsistent, 2 = consistent and accurate). The reported value will be the rating score.
Time frame
Measures collected at three points each round: baseline in week 1, post-treatment at the final stimulation session, and follow-up two weeks after the final session. Source ClinicalTrials.gov