]>
IRCT20260722070303N1 IRCT 2026-07-24 University of Tabriz Combined rTMS for Mild Cognitive Impairment Combined Effects of Repetitive Transcranial Magnetic Stimulation (rTMS) of the Cerebellum and the Dorsolateral Prefrontal Cortex (DLPFC) on Cognitive Functions in Older Adults with Mild Cognitive Impairment (MCI) 2026-04-21 anticipated 24 Recruiting https://irct.ir/trial/91811 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants who meet the eligibility criteria and provide written informed consent will be randomly allocated to one of four parallel groups, including Sham stimulation, Cerebellar rTMS, DLPFC rTMS, and Combined Cerebellar plus DLPFC rTMS, with an allocation ratio of 1:1:1:1. Block randomization will be performed using a computer-generated random sequence prepared by an independent researcher. Allocation concealment will be maintained using sequentially numbered, opaque, sealed envelopes. After completion of the baseline assessment, the intervention operator will open the corresponding envelope and administer the assigned intervention. The participants will remain blinded to group allocation, while the intervention operator will be aware of the assigned group, Blinding description: Participants who meet the eligibility criteria and provide written informed consent will be randomly allocated to one of four parallel groups, including Sham stimulation, Cerebellar rTMS, DLPFC rTMS, and Combined Cerebellar plus DLPFC rTMS, with an allocation ratio of 1:1:1:1. Block randomization will be performed using a computer-generated random sequence prepared by an independent researcher. Allocation concealment will be maintained using sequentially numbered, opaque, sealed envelopes. After completion of the baseline assessment, the intervention operator will open the corresponding envelope and administer the assigned intervention. The participants will remain blinded to group allocation, while the intervention operator will be aware of the assigned group. N/A Mild Cognitive Impairment (MCI). Intervention 1: Control group: transcranial magnetic stimulation over both the cerebellum and the left dorsolateral prefrontal cortex for 10 sessions, one session per day. During each session, the coil will first be positioned over the cerebellar target and then over the left dorsolateral prefrontal cortex. The coil will be held at a 90-degree angle relative to the scalp to prevent effective brain stimulation. The duration and sequence of sham stimulation will be similar to those used in the active intervention groups, using the same device and figure-of-eight coil. Intervention 2: Intervention group:followed by active repetitive transcranial magnetic stimulation over the left dorsolateral prefrontal cortex for 10 sessions, one session per day. First, the coil will be positioned over the cerebellar target at a 90-degree angle relative to the scalp, and sham stimulation corresponding to 1,000 pulses will be administered. Active stimulation will then be applied over the left dorsolateral prefrontal cortex at 10 Hertz, 100 percent of the resting motor threshold, and 2,000 pulses per session using a figure-of-eight coil. Intervention 3: Intervention group:Participants in this group will receive active cerebellar repetitive transcranial magnetic stimulation followed by sham stimulation over the left dorsolateral prefrontal cortex for 10 sessions, one session per day. Active cerebellar stimulation will be delivered at 5 Hertz, 90 percent of the resting motor threshold, and 1,000 pulses per session using a figure-of-eight coil. The coil will then be positioned over the left dorsolateral prefrontal cortex at a 90-degree angle relative to the scalp, and sham stimulation corresponding to 2,000 pulses will be administered. Intervention 4: Intervention group:magnetic stimulation over both the cerebellum and the left dorsolateral prefrontal cortex for 10 sessions, one session per day. Cerebellar stimulation will first be delivered at 5 Hertz, 90 percent of the resting motor threshold, and 1,000 pulses per session. Active stimulation will then be applied over the left dorsolateral prefrontal cortex at 10 Hertz, 100 percent of the resting motor threshold, and 2,000 pulses per session. Both stimulations will be delivered using the same device and figure-of-eight coil. Yes - There is a plan to make this available What will be shared: Deidentified individual participant data, the data dictionary, study protocol, statistical analysis plan, and a blank copy of the informed consent form will be available for sharing. The shared dataset may include demographic variables, group allocation, intervention parameters, and cognitive outcome scores measured before and after the intervention. All information that could identify participants will be removed before data sharing. When: Data and supporting documents will be available from 12 months after publication of the main study results and will remain available for 5 years. To whom: Researchers affiliated with recognized universities, research institutions, or scientific centers may request access after submitting a specific research proposal that is scientifically and ethically acceptable. Conditions: The data may be used for scientific analyses related to mild cognitive impairment, transcranial magnetic stimulation, reanalysis of study findings, systematic reviews, and meta-analyses. Access will require approval of the research proposal, a commitment to confidentiality, agreement not to attempt participant identification, and completion of a data use agreement. Commercial use or transfer of the data to third parties without written permission will not be allowed. Where to obtain: Requests should be submitted by email to the responsible researcher, Masoud Ghaffarvand Mokari, University of Tabriz, Tabriz, Iran. Applicants should provide their personal and institutional details, the purpose of the request, the proposed analysis plan, and relevant ethics approval documents. How to obtain: Requests must be submitted in writing and include the research objective, analysis plan, institutional affiliation of the researchers, and relevant ethics approval. The request will be reviewed by the responsible researcher and the study supervisor. A decision will be communicated within 30 days. Following approval and completion of a data use agreement, the files will be transferred through a secure electronic method. Comments:
public Masoud Ghaffarvand-Mokari
University of Tabriz, 29 Bahman Boulevard, Tabriz, East Azerbaijan Province, Iran.
Tabriz Iran (Islamic Republic of) 5166616471 +98 41 3334 0081 m.ghaffarvand@gmail.com University of Tabriz scientific Masoud Ghaffarvand Mokari
University of Tabriz, 29 Bahman Boulevard, Tabriz, East Azerbaijan Province, Iran.
Tabriz Iran (Islamic Republic of) 5166616471 +98 41 3334 1300 m.ghaffarvand@gmail.com University of Tabriz Iran (Islamic Republic of) Adults aged 50 years and older Diagnosis of Mild Cognitive Impairment according to Petersen Criteria MoCA score 19-25 Ability to provide informed consent medication during the previous 4 weeks Right-handedStable 50 years no limit Both Diagnosis of dementia History of epilepsy or seizure Metallic implants contraindicated for TMS Major psychiatric disorders History of stroke or other severe neurological disease Current use of medications lowering seizure threshold G31.84 Mild cognitive impairment, so stated Placebo Treatment - Devices Treatment - Devices Treatment - Devices Control group: transcranial magnetic stimulation over both the cerebellum and the left dorsolateral prefrontal cortex for 10 sessions, one session per day. During each session, the coil will first be positioned over the cerebellar target and then over the left dorsolateral prefrontal cortex. The coil will be held at a 90-degree angle relative to the scalp to prevent effective brain stimulation. The duration and sequence of sham stimulation will be similar to those used in the active intervention groups, using the same device and figure-of-eight coil. Intervention group:followed by active repetitive transcranial magnetic stimulation over the left dorsolateral prefrontal cortex for 10 sessions, one session per day. First, the coil will be positioned over the cerebellar target at a 90-degree angle relative to the scalp, and sham stimulation corresponding to 1,000 pulses will be administered. Active stimulation will then be applied over the left dorsolateral prefrontal cortex at 10 Hertz, 100 percent of the resting motor threshold, and 2,000 pulses per session using a figure-of-eight coil. Intervention group:Participants in this group will receive active cerebellar repetitive transcranial magnetic stimulation followed by sham stimulation over the left dorsolateral prefrontal cortex for 10 sessions, one session per day. Active cerebellar stimulation will be delivered at 5 Hertz, 90 percent of the resting motor threshold, and 1,000 pulses per session using a figure-of-eight coil. The coil will then be positioned over the left dorsolateral prefrontal cortex at a 90-degree angle relative to the scalp, and sham stimulation corresponding to 2,000 pulses will be administered. Intervention group:magnetic stimulation over both the cerebellum and the left dorsolateral prefrontal cortex for 10 sessions, one session per day. Cerebellar stimulation will first be delivered at 5 Hertz, 90 percent of the resting motor threshold, and 1,000 pulses per session. Active stimulation will then be applied over the left dorsolateral prefrontal cortex at 10 Hertz, 100 percent of the resting motor threshold, and 2,000 pulses per session. Both stimulations will be delivered using the same device and figure-of-eight coil. Episodic memory score. Timepoint: Before the intervention and after completion of 10 intervention sessions. Method of measurement: Rey Auditory Verbal Learning Test. Visuospatial working memory score. Timepoint: Before the intervention and after completion of 10 intervention sessions. Method of measurement: Corsi Block Tapping Test. Executive function score. Timepoint: Before the intervention and after completion of 10 intervention sessions. Method of measurement: Tower of London Test. Global cognitive function score. Timepoint: Before the intervention and after completion of 10 intervention sessions. Method of measurement: Montreal Cognitive Assessment. University of Tabriz Approved 2026-02-18 Ethics committee of Tabriz University 29 Bahman Blvd.,Tabriz, Iran 5166616471 Tabriz East Azarbaijan Iran (Islamic Republic of)