clinical-tms-clinic/SOPs/Treatment-Protocols/SOP-TMS-001-Treatment-Protocol.md

# Standard Operating Procedure: TMS Treatment Protocol

| Document ID | SOP-TMS-001 |
|-------------|-------------|
| Title | Transcranial Magnetic Stimulation Treatment Protocol |
| Revision | 1.0 |
| Effective Date | [DATE] |
| Author | [AUTHOR] |
| Approved By | [APPROVER] |
| Department | TMS Clinic |

---

## 1. Purpose

To establish standardized procedures for the safe and effective administration of Transcranial Magnetic Stimulation (TMS) therapy in accordance with FDA clearances, manufacturer guidelines, and clinical best practices.

## 2. Scope

This procedure applies to all TMS treatments including:
- Repetitive TMS (rTMS) for Major Depressive Disorder
- rTMS for Obsessive-Compulsive Disorder
- Intermittent Theta Burst Stimulation (iTBS)
- Other FDA-cleared or investigational protocols

## 3. Responsibilities

### 3.1 TMS Technician/Operator
- Position patient and equipment
- Determine motor threshold
- Administer treatment per prescription
- Monitor patient during treatment
- Document treatment parameters

### 3.2 Prescribing Physician
- Evaluate patient eligibility
- Prescribe treatment protocol
- Review progress and adjust treatment
- Manage adverse events
- Provide medical oversight

### 3.3 Clinical Coordinator
- Schedule treatments
- Track treatment compliance
- Coordinate patient assessments
- Maintain equipment logs

## 4. Definitions

| Term | Definition |
|------|------------|
| MT | Motor Threshold - minimum intensity to produce MEP |
| MEP | Motor Evoked Potential - observable motor response |
| rTMS | Repetitive Transcranial Magnetic Stimulation |
| iTBS | Intermittent Theta Burst Stimulation |
| DLPFC | Dorsolateral Prefrontal Cortex - common target for depression |

## 5. Equipment and Materials

- TMS device (FDA-cleared)
- Treatment coil (figure-8 or appropriate for indication)
- Positioning chair or table
- Ear protection (ear plugs)
- Treatment cap or head marking system
- Motor threshold determination tools
- Emergency equipment (as per emergency SOP)

## 6. Procedure

### 6.1 Pre-Treatment Assessment

#### 6.1.1 Initial Evaluation (First Treatment)
1. **Verify Prescription**
   - Diagnosis confirmed
   - Treatment protocol specified
   - Contraindications reviewed
   - Informed consent on file

2. **Safety Screening**
   Confirm absence of contraindications:
   - [ ] No ferromagnetic metal in head/neck
   - [ ] No implanted devices (pacemaker, cochlear implant, DBS)
   - [ ] No history of seizures (unless per protocol)
   - [ ] No unstable medical conditions
   - [ ] Current medications reviewed for seizure threshold effects
   - [ ] Pregnancy test negative (if applicable)

3. **Baseline Assessments**
   - PHQ-9 or HAM-D (depression)
   - Y-BOCS (OCD, if applicable)
   - Vital signs
   - Cognitive baseline if indicated

#### 6.1.2 Daily Pre-Treatment Check
Before each session:
- [ ] Patient identity verified
- [ ] Assess for new contraindications
- [ ] Confirm adequate sleep (>4 hours)
- [ ] Confirm no alcohol/illicit substances
- [ ] Confirm no significant medication changes
- [ ] Assess for current illness
- [ ] Review previous session tolerance

### 6.2 Motor Threshold Determination

**Required at:**
- First treatment session
- Any significant change in medications affecting neural excitability
- If treatment efficacy changes significantly
- Per physician order

**Procedure:**
1. Position patient comfortably
2. Place coil over motor cortex (M1) contralateral to dominant hand
3. Begin at 30-40% machine output
4. Deliver single pulses at 10-second intervals
5. Observe for thumb/finger movement (APB)
6. Increase intensity by 5% increments
7. Record lowest intensity producing 5 MEPs in 10 trials
8. Document MT and method used

| MT Parameter | Value |
|--------------|-------|
| Date | |
| Resting Motor Threshold (%) | |
| Target Muscle | |
| Number of Trials | |
| Determined By | |

### 6.3 Treatment Coil Positioning

#### 6.3.1 Left DLPFC Targeting (Standard Depression Protocol)
**5-cm Rule Method:**
1. Identify motor hotspot (from MT determination)
2. Measure 5 cm anteriorly along scalp surface
3. Mark position on treatment cap
4. Verify coil angle (45° to midline)

**Neuronavigation Method (if available):**
1. Register patient to MRI
2. Identify target coordinates
3. Position coil using navigation system
4. Document coordinates and trajectory

#### 6.3.2 Alternative Targets
- Right DLPFC (low-frequency protocol)
- Supplementary Motor Area (OCD)
- Other per protocol specification

### 6.4 Treatment Administration

1. **Patient Preparation**
   - Seat in treatment chair
   - Provide ear protection
   - Position head comfortably
   - Instruct patient on what to expect

2. **Equipment Setup**
   - Power on device and perform calibration
   - Select prescribed protocol
   - Set treatment parameters:
     | Parameter | Value |
     |-----------|-------|
     | Frequency (Hz) | |
     | Intensity (% MT) | |
     | Pulses per train | |
     | Inter-train interval | |
     | Total pulses | |
     | Duration | |

3. **Treatment Delivery**
   - Position coil at marked location
   - Maintain consistent coil contact
   - Begin treatment delivery
   - Monitor patient continuously
   - Pause if patient reports concerning symptoms

4. **Patient Monitoring During Treatment**
   Observe for:
   - Facial twitching (may indicate coil drift)
   - Signs of distress
   - Seizure warning signs
   - Excessive discomfort

### 6.5 Standard Treatment Protocols

#### Major Depressive Disorder - Standard rTMS
| Parameter | Left DLPFC |
|-----------|------------|
| Frequency | 10 Hz |
| Intensity | 120% MT |
| Train duration | 4 seconds |
| Inter-train interval | 26 seconds |
| Trains per session | 75 |
| Total pulses | 3,000 |
| Session duration | ~37.5 minutes |
| Total sessions | 30-36 |

#### Major Depressive Disorder - iTBS
| Parameter | Left DLPFC |
|-----------|------------|
| Pattern | 50 Hz bursts at 5 Hz |
| Intensity | 120% MT |
| Bursts per train | 10 (30 pulses) |
| Inter-train interval | 8 seconds |
| Total pulses | 600 |
| Session duration | ~3 minutes |
| Total sessions | 30-36 |

### 6.6 Post-Treatment

1. **Immediate Assessment**
   - Ask about side effects
   - Assess for headache, scalp pain
   - Evaluate mental status
   - Confirm safe to leave

2. **Documentation**
   Complete FRM-TMS-001 Treatment Log:
   - Date and session number
   - Treatment parameters used
   - Coil position
   - Patient tolerance
   - Any adverse effects
   - Operator signature

3. **Patient Instructions**
   - Mild headache/scalp discomfort common
   - OTC analgesics acceptable
   - Report severe/persistent symptoms
   - Confirm next appointment

### 6.7 Adverse Event Management

| Event | Severity | Action |
|-------|----------|--------|
| Scalp discomfort | Mild | Adjust position, OTC analgesic |
| Headache | Mild-Moderate | OTC analgesic, reduce intensity if persistent |
| Syncope | Moderate | Stop treatment, lie patient down, assess vitals |
| Seizure | Severe | Stop treatment, protect patient, follow seizure protocol |

**Seizure Response:**
1. Stop stimulation immediately
2. Note time
3. Protect patient from injury
4. Do not restrain
5. Call for help / activate emergency protocol
6. Monitor airway and breathing
7. Time seizure duration
8. Notify physician immediately
9. Complete incident report

## 7. Outcome Monitoring

| Assessment | Timing | Tool |
|------------|--------|------|
| Depression severity | Weekly | PHQ-9 or HAM-D |
| OCD severity (if applicable) | Weekly | Y-BOCS |
| Side effects | Each session | TMS side effect checklist |
| Treatment response | Sessions 10, 20, 30 | Physician evaluation |
| Remission assessment | End of acute course | Full clinical evaluation |

## 8. Documentation

- FRM-TMS-001 TMS Treatment Log
- FRM-TMS-002 Motor Threshold Record
- FRM-TMS-003 Side Effect Checklist
- Outcome assessment forms
- Equipment maintenance logs

## 9. References

- FDA clearance documentation
- Manufacturer operating manual
- Clinical practice guidelines (APA, CANMAT)
- Peer-reviewed TMS literature

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## Revision History

| Rev | Date | Description | Author |
|-----|------|-------------|--------|
| 1.0 | [DATE] | Initial release | [AUTHOR] |