---
title: Effects of the Quantity of Repetitive Transcranial Magnetic Stimulation(rTMS) on the Recovery After Stroke
nct_id: NCT01311271
overall_status: TERMINATED
phase: PHASE2, PHASE3
sponsor: Seoul National University Bundang Hospital
study_type: INTERVENTIONAL
primary_condition: Stroke
countries: South Korea
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01311271.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01311271"
ct_last_update_post_date: 2015-05-19
last_seen_at: "2026-05-12T07:21:35.685Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Effects of the Quantity of Repetitive Transcranial Magnetic Stimulation(rTMS) on the Recovery After Stroke

**Official Title:** Effects of the Quantity of Repetitive Transcranial Magnetic Stimulation on the Recovery of Upper Motor Function After Stroke: a Randomized Controlled Trial

**NCT ID:** [NCT01311271](https://clinicaltrials.gov/study/NCT01311271)

## Key Facts

- **Status:** TERMINATED
- **Why Stopped:** Only two subjects have been recruited from start of the study. We decided to start the study in this topic, after revising the study protocol.
- **Phase:** PHASE2, PHASE3
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 2
- **Lead Sponsor:** Seoul National University Bundang Hospital
- **Collaborators:** Asan Medical Center, Gyeongsang National University Hospital, Hanyang University, Seoul National University Boramae Hospital
- **Conditions:** Stroke, Hemiplegia
- **Start Date:** 2011-01
- **CT.gov Last Update:** 2015-05-19

## Brief Summary

The aim of this multicentric double blind study (randomized study) is to demonstrate the relationship between the amount of rTMS and the efficacy in the treatment of upper extremity motor deficits of stroke patients.

## Detailed Description

Repetitive transcranial magnetic stimulation (rTMS) can modulate excitability of the brain via non-invasive methods. In that sense, rTMS has been used to treat a variety of symptoms of stroke during last two decades. Especially, improvement of upper extremity function has been proved by many studies. However, it remains uncertain about the optimum amount of rTMS.

The aim of this multicentric double blind study (randomized study) is to demonstrate the relationship between the amount of rTMS and the efficacy in the treatment of upper extremity motor deficits of stroke patients.

Fifty-seven patients will be included with written consent. After randomization, the subject will receive 3 different amount of treatment rTMS-rTMS, Sham-rTMS, Sham-Sham) in double blind methods.

## Eligibility

- **Minimum age:** 20 Years
- **Maximum age:** 90 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* single mono-hemispheric ischemic or hemorrhagic stroke
* 1st onset stroke patient
* Upper extremity functional deficit attributable to acute stroke
* A stage of at least 3 on brunnström pre-treatment
* Written signed consent

Exclusion Criteria:

* Multiple lesion
* Bilateral cortical lesion and motor problems
* Cerebellar, or brainstem lesions
* History of more than one stroke
* Uncontrolled medical problems, such as: cardiopulmonary disease, severe rheumatoid arthritis, active joint deformity of arthritic origin, active cancer, or renal disease;
* Increased intracranial pressure
* History of seizure confirmed by interview and medical chart review
* Any individual who is on medication which is known to lower seizure threshold
* Other conditions that increase the risk of side effects due to rTMS procedures: a metal plate or metal object in the skull or eye, intracardiac line, increased intracranial pressure, cardiac pacemaker, implanted medication pump, tricyclic antidepressants, neuroleptics, history of seizure in the immediate family
* An age of less than 20 years old
* Any current actively treated medical or surgical condition or neurological or psychiatric illness other than stroke
* Complications that would prevent participation in the intervention, such as severe pain and severe spasticity
* Inability to cooperate outcome measure-related task
* Severe language disturbances
* Serious cognitive deficits
* Non-vascular cause for the neurological symptoms other central nervous system
* Disorder or peripheral neuropathy of the upper extremity
* Taking medication which interrupt brain activity
* Women who are pregnant
```

## Arms

- **Sham rTMS-Sham rTMS** (SHAM_COMPARATOR) — Sham rTMS for 2 weeks
- **Sham rTMS-Real rTMS** (EXPERIMENTAL) — Sham rTMS in the first week and real rTMS in the second week
- **Real rTMS-Real rTMS** (EXPERIMENTAL) — Real rTMS for 2 weeks

## Interventions

- **repetitive transcranial magnetic stimulation (rTMS)** (DEVICE) — 1 Hz frequency, 15 minutes, intensity of 90% resting motor threshold, with one session a day,

* Real: unaffected M1 hotspot
* Sham: coil perpendicular to scalp

## Primary Outcomes

- **Change in the Fugl-Meyer Assessment scale (upper extremity)** _(time frame: Baseline, weekly during treatment, at 4-week follow-up,and at 12-week follow-up)_

## Secondary Outcomes

- **Change in grip strength, lateral pinch force, tip pinch force, Purdue pegboard test, K-MBI, mRS,and brunnström stage** _(time frame: Baseline, weekly during treatment, at 4-week follow-up,and at 12-week follow-up)_

## Locations (1)

- Seoul National University Bundang Hospital, Seongnam-si, Gyeonggi-do, South Korea

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.whyStopped` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.seoul national university bundang hospital|seongnam-si|gyeonggi-do|south korea` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT01311271.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT01311271*  
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