The Effect of tDCS Combined With TMS on Cognitive Impairment and Motor Function After Stroke

NCT07573475 | Not Yet Recruiting DMC

• 1 other identifier: Nos.82302848a
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial aims to investigate whether transcranial electrical stimulation (tDCS) combined with transcranial magnetic stimulation(TMS) has an impact on the cognitive and motor functions of stroke patients, and to evaluate the safety of this protocol. The main objective is to answer the following question: Can electromagnetic combined stimulation of the left Dorsolateral prefrontal lobe(DLPFC) improve the performance of working memory, motor function and cognitively motor dual tasks in stroke patients? What is its mechanism of action? Participants will undergo a combined real or sham electromagnetic stimulation of 20 minutes of tDCS and 40 seconds of TMS once a day for 7 days. Researchers will compare the effects of real stimulation with sham stimulation to see if the real stimulation can bring better results to patients. Clinical evaluations (cognitive and motor scales) and functional Near-Infrared Spectroscopy(fNIRS) were conducted before and after stimulation to record relevant brain activities

Conditions

Stroke; Cognition Disorders

Outcome Measures

Primary Outcomes (6)

• n-back task accuracy rate

  n-back task record accuracy rate

  Baseline and 7-days

• n-back task reaction time

  n-back task record reaction time

  Baseline and 7-days

• functional connectivity during n-back task

  n-back task with fNIRS to record Oxy-Hb concentration

  Baseline and 7-days

• Verbal fluency test（VFT）accuracy rate

  VFT task record accuracy rate

  Baseline and 7-days

• Verbal fluency test（VFT）reaction time

  VFT task record reaction time

  Baseline and 7-days

• functional connectivity during Verbal fluency test（VFT）

  VFT task with fNIRS to record Oxy-Hb concentration

  Baseline and 7-days

Secondary Outcomes (2)

• Montreal Cognitive Assessment(MoCA)

  Baseline and 7-days

• isokinetic muscle strength test

  Baseline and 7-days

Study Arms (2)

real tDCS-TMS

EXPERIMENTAL

Behavioral: occupational therapy; Other: real tDCS; Other: real TMS

sham tDCS-TMS

SHAM COMPARATOR

Behavioral: occupational therapy; Other: sham tDCS; Other: sham TMS

Interventions

occupational therapy BEHAVIORAL

occupational therapy 1 hour a day for 7 days

real tDCS-TMS; sham tDCS-TMS

real tDCS OTHER

real 20 minutes of tDCS once a day for 7 days

real tDCS-TMS

sham tDCS OTHER

sham 20 minutes of tDCS once a day for 7 days

sham tDCS-TMS

real TMS OTHER

40 seconds of real TMS once a day for 7 days

real tDCS-TMS

sham TMS OTHER

40 seconds of sham TMS once a day for 7 days

sham tDCS-TMS

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Meeting the diagnostic criteria for hemorrhagic or ischemic stroke in the Chinese Guidelines for the Prevention and Treatment of Cerebrovascular Diseases(2nd edition), with the first onset, single hemisphere stroke, and confirmed by CT or MRI,course of diease 1-6 months;
• Age ranging from 30 to 80 years old;
• Native language is Mandarin or Cantonese;
• Right-handed;
• Diagnosed with post-stroke cognitive impairment(PSCI) by the MoCA scale;
• Able to cooperate in completing the speech repetition test;
• Normal hearing.

You may not qualify if:

• Currently receiving non-invasive brain stimulation treatment;
• Lesions involving the left DLPFC brain regions;
• History of epilepsy, mental illness,or other neurological or mental disorders;
• Any contraindications for transcranial electrical stimulation.

Sponsors & Collaborators

• Ke Dong, MD: lead

Study Sites (1)

Department of Rehabilitation Medicine, The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

Location

MeSH Terms

Conditions

Stroke; Cognition Disorders

Interventions

Occupational Therapy

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics

Central Study Contacts

Jingting Li

CONTACT

+86 13560365827; lijt53@mail.sysu.edu.cn

Hanjun Liu

CONTACT

+86 15920175118; lhanjun@mail.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 22, 2026
• First Posted: May 7, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: May 11, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: year 2028 data will become available and for 5 years

Locations

CN (1)