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IRCT20251020067695N1 IRCT 2025-10-24 The Institute for Cognitive Science Studies (ICSS) Effect of direct current brain stimulation on attention and balance in stroke patients Effectiveness of transcranial direct current stimulation (tDCS) on attention and balance in patients with stroke patients under dual-task conditions 2025-11-26 anticipated 32 Complete https://irct.ir/trial/86934 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Crossover, Purpose: Supportive, Other design features: Each participant will undergo four separate sessions, with a wash-out period of 7±2 days between sessions to prevent carryover effects. The order of tDCS conditions for each participant is randomized and counterbalanced. The tDCS device appears identical in all conditions to maintain participant blinding. Outcome assessors and the principal investigator remain blinded to the stimulation type until data collection is complete, and data analysis is performed after unblinding, Randomization description: Participants are randomly assigned to one of four tDCS conditions (DLPFC, M1, DLPFC+M1, Sham) using a four-by-four Latin square design. For each participant, a random number between 1 and 8 is generated; numbers 1 and 2 correspond to Sequence 1, 3 and 4 to Sequence 2, 5 and 6 to Sequence 3, and 7 and 8 to Sequence 4. If a sequence reaches its capacity, the selection range is adjusted according to the remaining sequences. Randomization unit: individual Randomization tool: Google Randomizer Allocation concealment: The codes and sequences are managed by a person independent of the principal investigator, who sets up the tDCS device. The principal investigator remains unaware of the stimulation type until the end of data collection, Blinding description: All participants are blinded to the type of tDCS stimulation they receive. Group allocation and session coding are performed by an independent person. The principal investigator and outcome assessors remain unaware of the stimulation type until data collection is completed, and are therefore blinded during this period. After data collection is completed and the codes are unblinded, the principal investigator has access to analyze the data. This procedure ensures a double-blind study, preventing prior knowledge of the stimulation type from affecting participants or outcome assessors. N/A stroke. Intervention 1: Intervention group 1: DLPFC stimulation; the anodal electrode is placed at F3 (left dorsolateral prefrontal cortex) and the cathode at AF8 (right supraorbital area). The M1 region receives sham stimulation, so only DLPFC is actually stimulated. The current intensity is 2 mA for 20 minutes, with gradual ramp-up and ramp-down over 30 seconds at the beginning and end of stimulation. Intervention 2: Intervention group 2: M1 stimulation; the anodal electrode is symmetrically placed at Cz (lower limb motor area) and the cathode on the left shoulder (extracephalic). The DLPFC region receives sham stimulation, so only M1 is actually stimulated. Current intensity is 2 mA for 20 minutes, with gradual ramp-up and ramp-down over 30 seconds at the start and end. Intervention 3: Intervention group 3: Simultaneous DLPFC and M1 stimulation; two anodal electrodes are placed simultaneously at F3 and Cz, and the cathodes at AF8 and left shoulder, respectively. Real stimulation is applied concurrently to both regions. The current intensity is 2 mA for 20 minutes, with gradual ramp-up and ramp-down over 30 seconds at the beginning and end. Intervention 4: Control group: Sham stimulation; the montage similar to the combined stimulation is applied, but the current is gradually ramped up for 30 seconds and then ramped down. This method allows the participant to feel initial stimulation without receiving real stimulation. The appearance and number of electrodes remain the same across all sessions to maintain blinding. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Individual participant data have not yet been collected, and the decision to share them will be determined after the completion of the study.
public Ali Sattari Dehkordi
4th Floor, Faraz Complex, Shahriar Alley, Robat 1st Street,
Isfahan Iran (Islamic Republic of) 8138916419 +98 31 3438 0274 sattari_a@icss.ac.ir The Institute for Cognitive Science Studies (ICSS) scientific Dr. Peyman Hassani Abharian
Institute for Cognitive Science Studies, Cognitive Science Boulevard, Shahid Qasem Soleimani Boulevard,
Pardis Iran (Islamic Republic of) 1658344575 +98 21 7629 1130 abharian1972@yahoo.com The Institute for Cognitive Science Studies (ICSS) Iran (Islamic Republic of) Diagnosed ischemic or hemorrhagic stroke confirmed by a neurologist and at least six months post-stroke Ability to walk independently for at least 9 meters without assistance or cane Ability to press the space key using the unaffected upper limb No severe visual or auditory impairments Mini-Mental State Examination (MMSE) score of 25 or higher Stability of routine pharmacological and rehabilitation treatments during the study period (without any change in the standard care of patients) Providing informed consent personally or through family representative no limit no limit Both History or presence of uncontrolled seizures or epilepsy Presence of active neurological or psychiatric disorders (e.g., Parkinson’s disease, multiple sclerosis, schizophrenia, bipolar disorder, major depression) Use of medications affecting neural excitability such as benzodiazepines or antiepileptic drugs Presence of metallic implants in the skull or electronic devices such as pacemakers Intolerance to electrical stimulation or occurrence of severe adverse effects during the first session Current or significant history of substance or alcohol abuse Severe or uncontrolled cardiac diseases Skin or skull abnormalities at electrode placement sites Absence from more than one intervention session Occurrence of balance disturbances in three or more trials (e.g., loss of balance requiring assistance or early termination for safety reasons) Recurrent stroke during the intervention period Withdrawal from participation during the study G46 Vascular syndromes of brain in cerebrovascular diseases Treatment - Devices Treatment - Devices Treatment - Devices Treatment - Devices Intervention group 1: DLPFC stimulation; the anodal electrode is placed at F3 (left dorsolateral prefrontal cortex) and the cathode at AF8 (right supraorbital area). The M1 region receives sham stimulation, so only DLPFC is actually stimulated. The current intensity is 2 mA for 20 minutes, with gradual ramp-up and ramp-down over 30 seconds at the beginning and end of stimulation. Intervention group 2: M1 stimulation; the anodal electrode is symmetrically placed at Cz (lower limb motor area) and the cathode on the left shoulder (extracephalic). The DLPFC region receives sham stimulation, so only M1 is actually stimulated. Current intensity is 2 mA for 20 minutes, with gradual ramp-up and ramp-down over 30 seconds at the start and end. Intervention group 3: Simultaneous DLPFC and M1 stimulation; two anodal electrodes are placed simultaneously at F3 and Cz, and the cathodes at AF8 and left shoulder, respectively. Real stimulation is applied concurrently to both regions. The current intensity is 2 mA for 20 minutes, with gradual ramp-up and ramp-down over 30 seconds at the beginning and end. Control group: Sham stimulation; the montage similar to the combined stimulation is applied, but the current is gradually ramped up for 30 seconds and then ramped down. This method allows the participant to feel initial stimulation without receiving real stimulation. The appearance and number of electrodes remain the same across all sessions to maintain blinding. Sustained attention. Timepoint: Before and after each stimulation session (4 sessions per participant); the interval between sessions is 7±2 days to allow washout of previous stimulation effects. Method of measurement: Visual Continuous Performance Test (CPT) with 150 visual stimuli, including 30 target stimuli; outcome measures: number of correct responses, omission errors, commission errors, and reaction time. Balance in single-task condition. Timepoint: Before and after each stimulation session (4 sessions); interval between sessions is 7±2 days (washout period). Method of measurement: Timed Up and Go (TUG) single-task test; measuring time to complete 3-meter path, number of responses, number of errors, and percentage of correct responses. Balance in dual-task condition (walking with serial subtraction). Timepoint: Before and after each stimulation session (4 sessions); interval between sessions is 7±2 days (washout period). Method of measurement: TUG with serial subtraction from a randomly selected three-digit number between 400 and 500; measuring time to complete the path, number of correct responses, and only the first calculation error in each walking trial is recorded as an error. Subsequent consecutive errors arising from the same initial mistake within the same trial are not counted. Errors in a new trial or independent errors are recorded separately. The Institute for Cognitive Science Studies (ICSS) Approved 2025-10-19 Research Ethics Committees of Institute for cognitive science studies Ministry of Health and Medical Education, Block A, 13th Floor, Central Headquarters, Simaye Iran Street, Between Flammak Jonoubi and Zarafshan, Qods Town Tehran Tehran Iran (Islamic Republic of)